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. 2025 Nov 26;11:150. doi: 10.1186/s40814-025-01724-3

Atrial fibrillation and primary care prevention and rehabilitation – a feasibility study

Caroline M Elnegaard 1,2,3,✉, Maria K Pedersen 12, Ann-Dorthe O Zwisler 1,5,6, Britt Borregaard 1,2, Jesper F Eilsø 3, Tove Sommer 3, Claus Tveskov 7, Jeroen M Hendriks 1,8,13,14, Axel Brandes 9,10, Signe S Risom 4,6,11
PMCID: PMC12659113  PMID: 41299666

Abstract

Background

The increasing prevalence of atrial fibrillation (AF) poses a global healthcare challenge, necessitating effective management strategies. AF is associated with reduced health-related quality of life (HRQoL), higher mental distress, and frequent hospital readmissions. Interventions like patient education and physical exercise have shown promise in reducing these burdens, yet their integration into primary care in a complex intervention set-up lacks thorough qualification and evidence.

Aim

This study aimed to investigate the feasibility of delivering a comprehensive prevention and rehabilitation intervention for individuals with AF in a primary Healthcare Center. Secondary objectives explored participant experiences and acceptability, needs and preferences, and changes in HRQoL, anxiety, and depression as well as feasibility of collecting patient-reported outcome measures (PROMs).

Trial design

A single-arm, intervention, feasibility study was conducted.

Methods

The primary feasibility outcomes were to investigate acceptability among participants and impact on the key outcomes HRQoL, anxiety and depression. Participants were consecutively recruited from a university hospital outpatient AF-clinic and referred to a primary Healthcare Center. The complex intervention included patient education, physical exercise, Medicinal yoga, psychosocial support and risk factor management. Quantitative data were collected using PROMs for HRQoL, anxiety and depression, while qualitative data were obtained through focus group interviews and field notes. Data analysis involved descriptive statistics and thematic analysis in a mixed-methods evaluation.

Results

Of the 50 participants enrolled, 43 (86%) completed the intervention. The complex intervention was feasible in a primary Healthcare Center with high acceptability. HRQoL improved from baseline to end-intervention and maintained at two-month follow-up, and symptoms of anxiety and depression decreased. Qualitative findings highlighted the importance of support from healthcare professionals and peers, alongside increased knowledge and tools to manage AF symptoms.

Harms

No adverse events were reported.

Conclusions

The study demonstrated the feasibility of a complex prevention and rehabilitation intervention for individuals with AF in a primary care setting and valuable insights were gained into the potential effectiveness and acceptability of the intervention. These findings underscore the importance of implementing comprehensive AF management programs and warrant further evaluation through large-scale randomized controlled trials.

Trial registration

ClinicalTrials Identifier: NCT06337045.

Supplementary Information

The online version contains supplementary material available at 10.1186/s40814-025-01724-3.

Keywords: Atrial fibrillation, Prevention, Rehabilitation, Complex intervention, Primary healthcare, Feasibility, Mixed-methods

Key messages regarding feasibility

  • What uncertainties existed regarding the feasibility?

    It was unclear whether the current set-up of cardiac prevention and rehabilitation in primary care settings in Denmark could effectively deliver a multidimensional prevention and rehabilitation intervention for individuals with atrial fibrillation.

  • What are the key feasibility findings?

    Conducting the intervention in a primary care setting yielded positive outcomes and acceptability of the intervention, demonstrating its feasibility in such settings.

  • What are the implications of the feasibility findings for the design of the main study?

    The findings of this feasibility study can form the basis for a large, randomised controlled trial to test, whether these findings can be replicated.

Background

The prevalence of atrial fibrillation (AF) is continuously increasing, and the condition poses a significant challenge globally [1, 2]. With a prevalence of 2–4% in adults and a 1 in 3-lifetime risk in Europe, the incidence and prevalence of AF have increased over the past two decades, mainly due to an increasing life expectancy and burden of risk factors and comorbidities [1]. This trend emphasizes the urgent need for effective management strategies. AF is associated with mental distress, reduced health-related quality of life (HRQoL), and a high rate of hospital readmissions, contributing to substantial healthcare costs; approximately 30% have at least one annual hospital readmission, and 10% have two or more [1, 3].

Research suggests that patient education [4–11] and physical exercise [12–14] might improve HRQoL and reduce symptom burden and hospital readmissions in individuals with AF. These interventions promoted self-efficacy, reduced insecurities and validated emotional responses in relation to living with AF [15]. In Denmark and other developed countries, the responsibility for preventive and rehabilitative interventions has moved across sectors from hospital level to a primary care setting [16, 17]. Although national and international guidelines recommend systematic referral to rehabilitation, including identification and management of risk factors and concomitant diseases, patient education and physical exercise [1, 18, 19], the integration of AF management into primary care provided rehabilitation lacks further qualification and evidence. To compare, cardiac rehabilitation (CR) for individuals with ischemic heart disease (IHD) and heart failure (HF) is well-established and based on a complex (i.e. multidimensional) intervention, including physical exercise, patient education, psychosocial healthcare, dietary intervention, smoking cessation and other risk factor management [20]. These interventions might also be relevant in AF.

Patient-centered, integrated care has gained traction internationally, emphasizing the importance of a comprehensive approach to prevention and rehabilitation interventions in AF across sectors and healthcare providers [1, 21–24]. Integrated care follows a holistic and comprehensive approach, focusing on medical treatment as well as non-pharmacological interventions such as physical exercise, patient engagement including patient education, psychosocial management and lifestyle interventions. Also, Mind–body interventions such as yoga have shown promise in improving mental health, HRQoL and blood pressure in individuals with AF, and yoga was experienced as a usable tool to handle emotions and symptoms related to AF episodes [25–29]. Despite the existing evidence, there is still a need for comprehensive evaluation of these interventions, using mixed-methods approaches to provide a broader understanding of their impact. Moreover, it is unclear whether the current set-up of CR and prevention in primary care settings in Denmark can effectively deliver integrated, complex prevention and rehabilitation interventions for individuals with AF.

Aim and objectives

Therefore, the primary aim of this study was to investigate the feasibility of delivering such an intervention for individuals with AF in a primary Healthcare Center. Further objectives of the study were:

  1. To explore the participant’s experiences and acceptability of participating in the intervention.

  2. To explore the participant’s needs and preferences for the intervention.

  3. To measure changes in HRQoL, anxiety and depression.

  4. To explore the feasibility of collecting patient-reported outcome measures as part of the intervention.

Methods

Design

This study was designed as a prospective, non-randomized, single-arm, intervention, feasibility study. A convergent mixed-methods design was used, i.e. the quantitative and qualitative data were collected within the same timeframe to enable a more comprehensive understanding of the study results and feasibility [30].

Registration and reporting

The study was retrospectively registered at clinicaltrials.gov (NCT06337045). The reporting was guided by the Consolidated Standards of Reporting Trials (CONSORT) extension to pilot and feasibility trials [31] (see checklist in additional file 1). Certain non-applicable areas of the CONSORT guideline were left out as according to Lancaster and Thabane [32].

Feasibility outcomes

According to the CONSORT extension, a feasibility study aimed at informing a future randomized controlled trial (RCT) assesses whether a future trial can be done, should be done, and, if so, how it should be done [31]. The success of this study is determined by its ability to demonstrate feasibility within a primary care setting. Therefore, the primary feasibility outcomes of this study are to investigate the acceptability among participants and to assess whether there is a positive impact on key outcomes such as HRQoL, anxiety and depression. Our progression criteria related to the primary feasibility outcomes included stopping the study if intermediate analyses indicated increased anxiety, depression or decreased HRQoL due to the intervention, or if participants expressed significant worry or non-acceptability towards participation. In such cases, healthcare professionals (HCPs) working the primary Healthcare Center where the interventions were carried out would address the individual concerns by talking to the participant. If multiple such observation would occur, the study group agreed to convene to discuss the necessary actions, potentially including the termination of the study.

Participants

Participants were consecutively included from February to November, 2019 (i.e. ongoing enrollment), at a university hospital outpatient clinic during a consultation with an AF specialist nurse at a regular follow-up appointment. Patients were eligible for participation if they were diagnosed with AF at the cardiology department at the hospital and had symptomatic AF rated by the modified European Heart Rhythm Association (mEHRA) score [33]. An mEHRA-score ≥ 2B was the main inclusion criterion, i.e. participants were moderately affected (normal daily activity not affected but troubled by the symptoms), severely affected (normal daily activity affected) or disabled (normal daily activity discontinued) by AF. Besides eligibility based on the mEHRA-score, at least one risk factor (see Table 1) had to be present. The risk factors were determined by the AF nurse during the consultation based on data from patient records, patient-reported outcome measures (PROMs) and patient interviewing. Exclusion criteria were ongoing treatment adjustments due to HF, ongoing CR, or if participation was not possible due to dementia, mental illness, language barrier or comorbidity. Eligible participants gave informed consent for participation and were then referred to a complex prevention and rehabilitation intervention at a primary Healthcare Center. Figure 1 shows the flow of study and data collection timepoints.

Table 1.

Inclusion criteria risk factors and measurement scale

Risk factors Measured as
Hypertension Treatment with > 1 drug, diagnosis verified by home-blood pressure measurement, 24-h ambulatory blood pressure measurement, or consultation blood pressure measurement > 160/90 mmHg
Diabetes mellitus HbA1c > 58 mmol/mol unless higher values are accepted due to other aspects
Obesity Body Mass Index (BMI) ≥ 30
Smoking Active smoker
Alcohol consumption  > 7 units per week for women and > 14 units per week for men (according to The Danish Health Authority 2019 guidelines [34]), or motivation for reduction
Physical inactivity Less than the recommended 30 min per day [35]
Sleep apnea Known sleep apnea or STOP-bang Sleep Apnea Questionnaire score > 3 [36])
Symptoms of anxiety or depression Assessed using the self-reported PROM: Hospital Anxiety and Depression Scale (HADS) ≥ 8 [37]
Mental vulnerability Defined as self-evaluated burdened life with high perceived stress, small social network, and/or low educational level (this item was inspired by references [38–40], which defines mental vulnerability as an individual with many psychosomatic symptoms and who finds it difficult to socialize
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Fig. 1.

Fig. 1

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Study flow and data collection time points

Abbreviations: AF, Atrial Fibrillation, HCP, Healthcare Professional, PROMs, Patient Reported Outcome Measures. Box colours: blue: at the hospital; green: at the Primary Healthcare Center; orange: data collection time points

The danish healthcare system

The Danish healthcare system works across three levels: the state (national level), the regions (regional level) and the primary care settings administered by local goverments (local levels). The state sets the rules and oversees healthcare in general. The regions manage hospitals, including emergency care and psychiatry, as well as healthcare provided by general practitioners (GPs) and specialists in private practice. The local goverments handle primary healthcare and social services [41]. The local goverments offer comprehensive rehabilitation programmes for all citizens in need based in primary healthcare centres and includes: physical and mental training, patient education and other measures for restoring both functional abilities and the general ability to selfcare [41].

Setting

This study took place at a primary Healthcare Center located in the region of Southern Denmark. The primary Healthcare Center is working with prevention, health promotion and rehabilitation for the following chronic diseases: heart disease, cancer, diabetes type-2 or chronic obstructive pulmonary disease. The team of HCPs working at the primary Healthcare Center is multidisciplinary, consisting of physiotherapists, occupational therapists, nurses and dieticians. Based on needs assessment and motivational interviewing during a consultation between the individual and a HCP, a complex intervention is offered at the primary Healthcare Center [42]. This approach was also used in this study. The complex intervention normally includes physical exercise, smoking cessation, alcohol consumption counselling, dietary interventions and/or patient education based on individual needs [43], i.e. these are Danish-national recommendations.

Complex intervention

The Medical Research Councils (MRC) guidelines for complex interventions [44] were the overarching framework of the study. The complex intervention (afterwards called “the intervention”) included the national recommended interventions described above, although with the patient education targeted at AF. Furthermore, we included Medicinal yoga (MediYoga) due to the promising evidence of mind–body interventions and group-based psychosocial support due to the association between AF and mental distress. The interventions are in accordance with current international and national guidelines [1, 18, 45]. All participants started and ended their intervention with a consultation with a HCP (nurse or occupational therapist) in the primary Healthcare Center. The elements and duration of the intervention are described in Fig. 2. All activities were optional and based on the individual needs assessment done in the starting consultation with the HCP, and the participants’ motivation and preferences towards the intervention components. Thus, the total time spent as part of the intervention varied for each participant and all participants entered into their individual collection of interventions once referral procedure was done. Furthermore, if the participant found it relevant and important to their treatment course, significant others were allowed to participate in the patient education, group-based psychosocial support interventions and in the individual consultations with the HCP. Only some participants chose this option and we did not collect any data or had separate questions for significant others.

Fig. 2.

Fig. 2

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The complex intervention in the primary Healthcare Center

Abbreviations: HCPs, Healthcare Professionals, AF, Atrial Fibrillation, MediYoga, Medicinal Yoga

Data collection

Sample size

As the primary objective was investigating feasibility, no formal sample size calculation was performed. According to Billingham et al., the median sample size per arm reported in feasibility studies are 36 (IQR: 25–50) [46]. As our study was single-armed, we sought to reach a minimum of 36 participants. Related to the primary feasibility outcomes, we assessed that a sample size of minimum 36 participants would be sufficient to assess impact on the key outcomes and acceptability among participants.

Quantitative

Baseline characteristics of the participants were collected from hospital patient records. Two PROMs were used and collected at three time points: T0 (hospital consultation with the AF nurse), T1 (the end of the intervention, in the primary Healthcare Center) and T2 (two-month follow-up) (Fig. 1). The participants also responded to four evaluative questions collected at T1. An overview of outcomes and measurement instruments is shown in Table 2. PROMs were administered by SurveyXact [47]. Paper-based versions were used at T0 and T1 if participants had not completed the online version before the consultations and subsequently entered into SurveyXact. At T2, the participants were at home, and non-respondents were phoned.

Table 2.

Overview of outcomes and measurement instruments

Outcome Instrument Items and scales Measured at timepoint
Health-related Quality of Life HeartQoL 14 items, 3 scales (global, physical and emotional). Measured on a 4-point Likert scale from 0–3, where a higher score represents better HRQoL T0, T1, T2
Symptoms of Anxiety and Depression The Hospital Anxiety and Depression Scale (HADS) 14 items, 2 scales (anxiety and depression). Measured on a 4-point Likert scale from 0–3, where 0 reflects the positive extreme (no symptoms), and 3 reflects the negative extreme of the scale (symptoms) T0, T1, T2
Four evaluative questions

Self-made instrument for participant evaluation of the total intervention:

1) Did the HCPs listen to you?

2) Did the HCPs prioritize what mattered most to you?

3) Did you experience a coherence in the intervention?

4) Did you experience the intervention as relevant to your situation?

 Rated on a 5-point Likert-scale with the values “Very much”, “Much”, “Maybe”, “Little”, and “Very little” T1
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Measures

The PROMs were the HeartQoL questionnaire measuring HRQoL [48, 49] and the Hospital Anxiety and Depression scale (HADS) measuring symptoms of anxiety and depression [37, 49]. HeartQoL contains three scales, a global overall scale and a physical- and emotional sub-scale. It has a 14-item self-assessment scale enabling the respondents to recall how much their heart problems have bothered them during the past four weeks on a 4-point Likert scale from 0–3, where a higher score represents better HRQoL. The global score reflects all items and is calculated by dividing the sum of the scored items by the number of scored items. The same principle applies to the physical and emotional subscales, which hold 10 items and 4 items, respectively [48, 49]. HADS is a 14-item self-assessment scale, 7 items for each domain. All items are rated on a 4-point Likert scale, where 0 reflects the positive extreme and 3 reflects the negative extreme of the scale. For each domain, a score ranging from 0 to 21 can be obtained and categorized as “normal” (0–7 points), “possible presence of a disorder” (8–10 points), and “probable presence of a disorder” (11–21 points) [49]. Lastly, four self-made questions for participant evaluation of the total intervention were constructed and applied at T1 (Table 2). All four questions were rated on a 5-point Likert-scale with the values “Very much”, “Much”, “Maybe”, “Little”, and “Very little”.

Qualitative

Focus group interviews were conducted twice among a convenience sample just before T1 (Fig. 1). A semi-structured interview guide covering participant experiences and acceptability, rehabilitation needs and intervention preferences was used. In total, 11 participants were invited to the two interviews randomly selected among participants who had almost finished the intervention at the time of the interview. Thereby minimizing their recall period as well as gaining a detailed picture of their experiences with the total intervention. Interviews were recorded and transcribed. Names were changed to ensure anonymization. One of the authors (TS), a nurse with interviewing experience, conducted the focus group interviews. The author (CME) took part in the interviews as observer of the group dynamics and ensured everybody could contribute with their experiences. Furthermore, field notes from HCPs collecting the data were used to evaluate the feasibility of collecting PROMs. Field notes were written during the intervention and collected at the end of the study.

Data analysis

Quantitative

Descriptive statistics (median, range, frequencies and percentages) were used to describe participant characteristics, needs and choices of interventions as well as levels of HRQoL and symptoms of anxiety and depression. The results of the four evaluative questions (see Table 2) were presented as frequencies.

Qualitative

Based on the research questions, we conducted an inductive, semantic thematic analysis guided by Braun and Clarke’s [50] six stages of thematic analysis. Both the focus group interview data and the field notes were integrated in the analysis. As the analysis was based on the research questions, codes were defined a priori as “Experiences of participating and acceptability”, “Needs and preferences of interventions”, “Changes in HRQoL, anxiety and depression” and “Collecting PROMs”. Based on these initial codes, the interviews and field notes were inductively and semantically analyzed, as the analysis was driven by the data content and explored meaning at the explicit level based on what was actually said [50]. Relevant data extracts were pooled under these codes and finally into themes. Two authors (CME and MKP), independently of each other, analyzed the qualitative data based on the codes and reflected on themes. Three of the authors (CME, MKP and SSR) met and discussed the themes. NVivo 14 [51] was used for analysis of the qualitative data. A Table presented in additional file 2 describes the entire analysis process.

Mixed-methods analysis

The mixed-methods analysis involved merging the quantitative and qualitative data according to the secondary objectives of the study into side-by-side joint displays (visual presentation) [52], followed by a thorough discussion of the results. A quantitative and qualitative summary was provided along with mixed-methods inferences (meta-inferences) to evaluate the alignment between the findings. The alignment was evaluated as either confirmation (findings support each other), expansion (findings provided further insights) or discordance (findings contradicted each other) [30, 52].

Results

An adjusted CONSORT flowchart shows the flow of the study participants (Fig. 3). In total, 50 individuals agreed to participate, and 43 participants (86%) completed the intervention. Thus, the required minimum sample size was reached. Table 3 presents the baseline characteristics of the participants who completed the intervention. The median age was 66 years (range from 52–81 years) and 53% were female. Most (49%) were retired from work and living with partner (58%).

Fig. 3.

Fig. 3

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Flowchart

Abbreviations: HF, Heart Failure, CR, Cardiac Rehabilitation. *These were six males and one female. Age from 53 to 76 years. Two were still working and one seeking employment, four retired. Six of them were overweight/obese; one smoked and over-consumed alcohol. Their T0 HeartQoL global was 2.64, HADS-A was 2, HADS-D was 4. Flowchart based on the CONSORT extension to pilot and feasibility trials

Table 3.

Participant characteristics at baseline

N = 43
Variable Level Median (range) Number (percentage)
Age Continuous 66 (52–81)
Sex Male 20 (47)
Female 23 (53)
Inclusion criteria
mEHRA1-score IIB 13 (30)
III 30 (70)
Risk factors
Hypertension2 Yes 18 (42)
Diabetes3 Yes 3 (7)
Obesity BMI4 ≥ 30 16 (37)
BMI, continuous 28.1 (19.5–45)
Smoking Yes 7 (16)
Alcohol overconsumption5 Male overconsumption 1 (2)
Female overconsumption 3 (7)
Physical inactivity6 Less than recommendation 36 (84)
Sleep apnoea7 STOP-bang score > 3 25 (58)
STOP-bang score, continuous 3 (0–7)
Anxiety or depression8 HADS-A or HADS-D ≥ 8 19 (44)
HADS-A, continuous 7 (0–15)
HADS-D, continuous 4 (0–13)
Mental vulnerability9 Yes 22 (51)
More than one risk factor Yes 37 (86)
Type of AF Paroxysmal 24 (56)
Persistent 12 (28)
Permanent 4 (9)
Atrial flutter 3 (7)
Time since diagnosis Less than one year 16 (37)
More than one year 27 (63)
Experience of relapses Yes 29 (67)
CHA2DS2-VASc Score10 Low risk, male/female 1 (2) / 7 (16)
Moderate risk, male/female 9 (21) / 8 (19)
High risk, male/female 10 (23) / 8 (19)
Civil status Living with partner 25 (58)
Living alone 18 (42)
Occupational status Working 11 (26)
Reduced hours working (flexible job) 3 (7)
Sick leave 4 (9)
Retired 21 (49)
Early retirement 4 (9)
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1mEHRA: modified European Heart Rhythm Association-score

2Hypertension (treatment with > 1 medicament, or diagnosis verified by home-blood pressure or ambulatory blood pressure in 24 h or if blood pressure is measured in the AF-clinic > 160/90)

3Diabetes mellitus (HbA1c > 58 mmol/mol unless higher values are accepted due to other aspects)

4BMI: Body Mass Index

5Alcohol consumption (> 7/14 units per week for women/men [34], or motivation for reduction)

6Physical inactivity (less than the recommended 30 min per day [35])

7Known sleep apnea or STOP-bang Sleep Apnea Questionnaire score > 3 [36])

8Anxiety or depression (the Hospital Anxiety and Depression Scale (HADS) > 7 [37])

9Mental vulnerability (inspired by [38–40]), locally translated to self-evaluated strain in life based on low educational level, small social network, high perceived stress, etc.

10CHA2DS2-VASc Score [1]: Low risk is a score of 0 in men and 1 in women. Moderate risk is a score of 1 in men and 2 in women, oral anticoagulation therapy should be considered. High risk is a score of 2 or higher in men, and 3 or higher in women, oral anticoagulation therapy is indicated

The results of PROMs, based on median score changes, show that HRQoL increased from baseline (T0: 1.93) to the end of intervention (T1: 2.36) and maintained this level two months after ending the intervention (T2: 2.43). Symptoms of anxiety and depression decreased from baseline (T0, HADS-A: 7 and HADS-D: 4) to the end of intervention (T1, HADS-A: 3 and HADS-D: 1) and maintained this level two months after ending the intervention (T2, HADS-A: 4 and HADS-D: 2). For the possible presence of symptoms of anxiety and depression indicated by a HADS score ≥ 8, results show that the percentage decreased accordingly. These results can be seen in the table presented in Figure 7.

Fig. 7.

Fig. 7

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Joint display regarding changes in HRQoL, anxiety and depression

Qualitative results

The eleven informants in the two focus group interviews were six females and five males. They were aged 52–79 years. A Table in additional file 3 presents age and sex information for each informant ID number.

Figure 4 presents the codes and themes of the thematic analysis. In the end, nine themes were agreed upon and the headings of the themes were: Being understood and supported; Including family members in rehabilitation; What comes next; Knowing what you need; Needs and preferences related to specific interventions; Gaining tools and knowledge from the intervention; Relation; Using data; and Academic systematism.

Fig. 4.

Fig. 4

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Codes and themes of the thematic analysis

Abbreviations: HRQoL, Health-related Quality of Life, PROMs, Patient Reported Outcome Measures. The four bobbles in the shaded area represents the codes and the white area represents the themes

Mixed-methods results

The side-by-side joint displays (Figures 5, 6, 7 and 8) showed that the quantitative and qualitative results mutually expanded the understanding of the findings. The joint display regarding “experiences of participating and acceptability” related to the primary care complex intervention showed that the participants felt listened to and supported by HCPs and peers, which were very valuable and led to an experience of coherence (Fig. 5). The joint display regarding the “needs and preferences of the interventions” showed that it was difficult for the participants to know what they needed when they had just been diagnosed with a heart disease, and the most important thing was the availability of a prevention and rehabilitation offer (Fig. 6). The joint display regarding “changes in HRQoL, anxiety and depression” showed the participants’ decreased symptoms of anxiety and depression and increased HRQoL, and the participants experienced that gaining tools and knowledge from the interventions originated these effects (Fig. 7). The joint display regarding the feasibility of “collecting PROMs” pointed to some important aspects of a successful data collection, such as establishing and maintaining a trusting relationship with the participants and using PROMs for purposes other than statistics like consultation tools and tools for case discussion across sectors (Fig. 8).

Fig. 5.

Fig. 5

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Joint display regarding the experience of participating in the intervention and acceptability

Fig. 6.

Fig. 6

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Joint display regarding needs and preferences of the interventions

Fig. 8.

Fig. 8

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Joint display regarding the feasibility of collecting PROMs

Harms

There were no adverse events reported (deaths, hospital readmissions, unintended consequences or harms) due to the intervention during the study. This evaluation was based on “nothing mentioned” by HCPs in cooperative project meetings between the HCPs in the primary Healthcare Center and HCPs from the hospital department as well as no participants reported any adverse events or lack of acceptability during the study. Furthermore, the results of the PROMs did not indicate that the participants were affected negatively by participating. Thus, no observations were made that would terminate the study.

Discussion

The findings of this study provide valuable insights into the feasibility, acceptability and potential outcomes of a complex prevention and rehabilitation intervention for individuals with AF provided in a primary Healthcare Center. Conducting the intervention in a primary care setting yielded positive results, demonstrating its feasibility, acceptability and viability in such settings. The participants improved outcomes in terms of HRQoL, anxiety and depression and the intervention was well received as participants felt supported and highlighted the importance of the intervention. Similar findings were shown in another feasibility study from a real-world, English set-up testing an exercise-based cardiac rehabilitation intervention with education sessions. The study found lower anxiety and depression and improved six-minute walk test [53]. Our mixed-methods analysis provided an expanded understanding of the findings revealing the significance of support from HCPs and peers as well as increased knowledge of AF and tools to tackle AF, which contributed to the perceived effectiveness of the intervention. Additionally, participants' highlighted relying on individual consultations with HCPs to determine relevant interventions, emphasizing the importance of a tailored, comprehensive care offer. Furthermore, the feasibility of collecting PROMs during the intervention was demonstrated, with participants willing to respond and valuing their use beyond statistical purposes.

The study adhered to the guidelines recommending multi-dimensional, integrated, tailored care [1, 19] across sectors and disciplines [1, 18]. Thus, in this study, participants received evidence-based care tailored to their individual needs. The intervention specifically targeted the management of risk factors and lifestyle modifications, patient education including medication adherence, and psychosocial management, as according to the integrated care model [1]. The medical treatment (i.e. stroke prevention, symptom control and management of comorbidities) was managed at the hospital. The positive outcomes observed in this study provide additional support for the efficacy of integrated care with guideline-concordant interventions, which is also shown in other studies (however, mostly focused on physical exercise and patient education) [5, 8, 9, 54–56]. Furthermore, the results of a meta-analysis showed a 49% and 42% decrease in all-cause mortality and cardiovascular hospitalizations, respectively, with integrated care [22]. Implementation of integrated care requires a change in the approach to patient care, which involves key stakeholders as well. This can be further discussed by looking at the framework for complex interventions [44]. This study went through the development of the intervention and investigation of its feasibility always considering the core elements of the framework like context, key stakeholders and economic considerations. To complete the framework, the intervention still needs large-scale evaluation and implementation. Based on this feasibility study, we can already consider core elements related to implementation. The Danish context in which the integrated complex intervention was provided is dynamic and multi-dimensional. Key dimensions include physical, spatial, organizational, social, cultural, political and economic features in the healthcare system [44]. In many European countries, key stakeholders representing the context are politicians who allocate funds to specific objectives based on a political agreement. This applies to both the state, region, and local levels [41]. In the local governments, the politicians’ need to be convinced that the limited funds available should also be allocated to support an integrated, complex intervention set-up in AF. Thus, making the politicians confident with the efficacy of the intervention to get it on the political agenda is key to implementation. A good and valid argument could be cost savings related to AF. A study focusing on costs in the ‘Atrial fibrillation Better Care’ (ABC) pathway showed a cost saving of 542 dollars per 1-patient-year for ‘C’ vs. ‘non-C’ in a non-fatal cardiac event or ischemic stroke [57]. ‘C’ means the identification and management of concomitant diseases, risk factors and unhealthy lifestyle which prevents and reduces AF burden and symptom severity [1]. In Denmark, the local governments co-finance the hospitals [41], and it would be a prioritization to lower the costs of hospital readmissions. The HCP hours were not calculated in this study, but it would be important to consider the costs of educating the HCP on this specific patient group and the HCP hours to deliver the intervention.

Methodological considerations

The study's generalizability should be considered in light of the recruitment strategy and intervention design. Participant selection from the hospital outpatient clinic based on AF symptoms and risk factors introduces selection bias, limiting applicability to the broader AF population.

Also, it is well-known in rehabilitation research that it tends to attract participants who may not be socially vulnerable, in low socio-economic status, and/or with high comorbidity, etc., potentially skewing the findings [58]. However, the intervention's real-world resemblance in primary care settings suggests potential applicability to similar settings.

Strengths of the study include adherence to established methodological guidelines such as MRC guidelines for complex interventions [44] and CONSORT extension to pilot and feasibility trials [31], ensuring the methodological robustness. The convergent mixed-methods design allowed for a nuanced understanding of the feasibility, acceptability and potential effectiveness. Merging the quantitative and qualitative data into joint displays revealed confirming and expanding meta-inferences and led to a better understanding of the study results [30, 52]. Allthough it can be stated that our thematic analysis approach was initially deductive (through the lens of the objectives), we believe it was a strength that we continued in an inductive, semantic approach, driven by the data content and exploring meaning by what was actually said. This opened our analysis to focusing on what was at stake and important to the participants. Thus, the analysis provided a detailed examination of the qualitative data [50]. We reached the minimum inclusion target of at least 36 participants [46], and together with the use of validated PROMs and achieving a high response rate, this enhanced the reliability of the outcomes. The enrollment was ongoing, which we believe a strength of the study, as it replicated the real-world scenario.

Some limitations must be acknowledged. First, in many mixed-methods studies, data collection is designed to explore the same themes. For example, an interview guide may elaborate on the items in PROMs, which helps the process of integrating results directly with each other. However, this study did not follow that approach, as it was not the purpose, and the interview guide was designed according to the secondary objectives. Though limiting direct integration of results [30]. Second, though reaching 43 participants, the small sample size and non-normal distribution of data precluded formal statistical analysis of intervention effects or using measures like minimal important difference [59], thus warranting descriptive analysis. Third, absence of a control group means that we could not out-rule that the observed effect could have occurred by itself over time. Participants in the interviews highlighted the value of being with peers and we could not out-rule a peer-to-peer effect either. Another study showed increased HRQoL and decreased anxiety and depression following a peer-mentor intervention among individuals with myocardial infarction [60], indicating potential peer-to-peer effect. Fourth, inability to evaluate individual intervention effects are a limitation to the study. Had many more participants been included in the study, it would have been relevant to conduct multifactorial analysis to determine if a specific intervention was more effective than others [61]. Fifth, a small proportion of missing data was seen at T2 as we had nine individuals (21%) who did not respond to PROMs at T2, and this warrants consideration for the impact on the overall findings. Applying their scores from T1 at T2 (assuming no further increase or decrease) did not change the median results on anxiety and depression, and the results on HRQoL decreased a bit but were almost the same compared to the table presented in Figure 7 at T1 (see additional file 4). Thus, the impact of missing data is considered limited.

Implications for clinical practice

The findings of this study showed that it was feasible to conduct a complex prevention and rehabilitation intervention for individuals with AF in a primary Healthcare Center. Thus, clinical practice can draw inspiration from this study to implement similar interventions for individuals with AF working closely together in primary and secondary care. HCPs can also draw inspiration from the insights gained from the participants’ experiences and preferences to tailor care to individual needs as recommended in international guidelines [1]. A concrete example is that of the participants finding it difficult to know what they need by themselves, and therefore rely on the guidance of HCPs. Moreover, collecting PROMs underlined the importance of incorporating individual perspectives into AF management in clinical practice and is also recommented by experts in the field [62], this study gives a concrete example of how to do this in practice.

Future research

Future research should prioritize large, multicenter RCTs based on a sample size calculation, testing a complex intervention design to confirm and expand the promising results of this study. Adopting a complex intervention approach tailored to the multifaceted nature of AF is essential, incorporating various components such as psychosocial support, mind–body interventions and lifestyle modifications. Utilizing mixed-methods and multifactorial designs can provide a more comprehensive understanding of intervention impact, accounting for the diverse factors influencing outcomes in individuals with AF. By further evaluating the intervention's efficacy and scalability, such RCT can provide valuable evidence to inform the development and implementation of comprehensive AF prevention and rehabilitation programs. These strategies will further enhance the validity and generalizability of study findings, potentially impacting management approaches for individuals with AF.

Conclusion

In conclusion, this study found it feasible to deliver a complex prevention and rehabilitation intervention for individuals with AF in a primary care setting. Through the exploration of participant experiences, needs and preferences, as well as the assessment of changes in HRQoL, anxiety and depression, valuable insights were gained into the potential effectiveness and acceptability of the intervention. Moreover, the feasibility of collecting PROMs as part of the intervention was demonstrated. These findings lay a solid foundation for implementing a future full-scale RCT.

Supplementary Information

Additional file 1. (230.5KB, doc)
Additional file 2. (182.6KB, pdf)
Additional file 3. (182.2KB, pdf)
Additional file 4. (280.5KB, pdf)
Additional file 5. (15.6KB, docx)

Acknowledgements

The authors would like to acknowledge and thank all participants who took part in this study. Thanks to the nurses at the atrial fibrillation clinic at Svendborg Hospital, Odense University Hospital, Region of Southern Denmark, for including participants to the study. Thanks to the healthcare professionals working in the primary Healthcare Center in the local government Svendborg, Region of Southern Denmark, for conducting the intervention and collecting data. Thanks to the Danish Heart Association at Funen and their local committee in Svendborg for participating actively with advice and guidance, and for allocating representatives who participated and peer-mentored with the participant.

Abbreviations

ABC

Atrial fibrillation Better Care

AF

Atrial fibrillation

BMI

Body Mass Index

CHA2DS2-VASc Score

CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk

CONSORT

The Consolidated Standards of Reporting Trials

CR

Cardiac rehabilitation

EHRA

European Heart Rhythm Association

ESC

European Society of Cardiology

GPs

General practitioners

HADS

The Hospital Anxiety and Depression Scale

HF

Heart failure

HCPs

Healthcare professionals

HRQoL

Health-related quality of life

IHD

Ischemic heart disease

MediYoga

Medicinal yoga

MRC

Medical Research Councils

PROMs

Patient reported outcome measures

RCT

Randomized controlled trial

Authors’ contributions

CME: Design, acquisition of data, data analysis, interpretation of data, responsible for drafting the manuscript. MKP: Data analysis, interpretation of data, drafted manuscript, revised manuscript. ADOZ: Conception, design, interpretation of data, revised manuscript. BB: Interpretation of data, revised manuscript. JFE: Conception, design, interpretation of data, revised manuscript. TS: Conception, design, acquisition of data, interpretation of data, revised manuscript. CT: Conception, design, interpretation of data, revised manuscript. JMH: Interpretation of data, revised manuscript. AB: Interpretation of data, revised manuscript. SSR: Conception, design, data analysis, interpretation of data, drafted manuscript, revised manuscript. All authors approved the final submitted manuscript and agree to be personally accounTable for their contributions and to the accuracy and integrity of the work.

Funding

Open access funding provided by University of Southern Denmark The primary Healthcare Center in cooperation with the Department of Cardiology at the local hospital (2018–2020), received funding from the Danish Health Authority to develop, trial and evaluate a complex intervention aimed at individuals with AF. This project is part of a PhD partially funded by a PhD faculty scholarship from the University of Southern Denmark, a PhD stipendium from the Region of Southern Denmark and running costs from the fund to support independent, strategic clinical research in the Region of Southern Denmark.

Data availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethics approval and consent to participate

The study was retrospectively registered at clinicaltrials.gov (NCT06337045). The study conformed with the principles outlined in the Declaration of Helsinki. Participants have provided written informed consent to participate in the study and data collection. The Danish Health Authority approved the use of the data in this study. Data were collected during the year 2019. The study is registered at the Regional Committees on Health Research Ethics for Southern Denmark (20222000–24) as well as at the Region of Southern Denmark’s record of data processing activities (22/28369).

Consent for publication

Along with the consent to participate, the participants were informed about the publication of results and also consented to this.

Competing interests

The authors declare that they have no competing interests.

Footnotes

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

  • 1.Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). European heart journal. 2020.
  • 2.Global Burden of Disease (GBD). GBD Compare 2019 [Available from: https://vizhub.healthdata.org/gbd-compare/#.
  • 3.Steinberg BA, Kim S, Fonarow GC, Thomas L, Ansell J, Kowey PR, et al. Drivers of hospitalization for patients with atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. 2014;167(5):735-42.e2. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 4.Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, et al. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. European heart journal. 2012;33(21):2692–9. [DOI] [PubMed]
  • 5.Risom SS, Zwisler AD, Rasmussen TB, Sibilitz KL, Madsen TL, Svendsen JH, et al. Cardiac rehabilitation versus usual care for patients treated with catheter ablation for atrial fibrillation: results of the randomized CopenHeartRFA trial. Am Heart J. 2016;181:120–9. [DOI] [PubMed] [Google Scholar]
  • 6.Clarkesmith DE, Pattison HM, Lip GY, Lane DA. Educational intervention improves anticoagulation control in atrial fibrillation patients: the TREAT randomised trial. PLoS ONE. 2013;8(9):e74037. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 7.Fuenzalida C, Hernandez G, Ferro I, Siches C, Ambros A, Coll-Vinent B. Long-term benefits of education by emergency care nurses at discharge of patients with atrial fibrillation. Int Emerg Nurs. 2017;35:7–12. [DOI] [PubMed] [Google Scholar]
  • 8.Hendriks JM, Vrijhoef HJ, Crijns HJ, Brunner-La Rocca HP. The effect of a nurse-led integrated chronic care approach on quality of life in patients with atrial fibrillation. Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2014;16(4):491–9. [DOI] [PubMed] [Google Scholar]
  • 9.Joensen AM, Dinesen PT, Svendsen LT, Hoejbjerg TK, Fjerbaek A, Andreasen J, et al. Effect of patient education and physical training on quality of life and physical exercise capacity in patients with paroxysmal or persistent atrial fibrillation: A randomized study. J Rehabil Med. 2019;51(6):442–50. [DOI] [PubMed] [Google Scholar]
  • 10.Palm P, Qvist I, Rasmussen TB, Christensen SW, Håkonsen SJ, Risom SS. Educational interventions to improve outcomes in patients with atrial fibrillation—a systematic review. Int J Clin Pract. 2020;74:1–13. [DOI] [PubMed] [Google Scholar]
  • 11.Carter L, Gardner M, Magee K, Fearon A, Morgulis I, Doucette S, et al. An integrated management approach to atrial fibrillation. J Am Heart Assoc. 2016. 10.1161/JAHA.115.002950. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 12.Risom SS, Zwisler AD, Johansen PP, Sibilitz KL, Lindschou J, Gluud C, et al. Exercise-based cardiac rehabilitation for adults with atrialfibrillation (Review). Cochrane Database of Systematic Reviews. 2017(2):CD011197. [DOI] [PMC free article] [PubMed]
  • 13.Smart NA, King N, Lambert JD, Pearson MJ, Campbell JL, Risom SS, et al. Exercise-based cardiac rehabilitation improves exercise capacity and health-related quality of life in people with atrial fibrillation: a systematic review and meta-analysis of randomised and non-randomised trials. Open Heart. 2018;5(2):e000880. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14.Malmo V, Nes BM, Amundsen BH, Tjonna AE, Stoylen A, Rossvoll O, et al. Aerobic interval training reduces the burden of atrial fibrillation in the short term: a randomized trial. Circulation. 2016;133(5):466–73. [DOI] [PubMed] [Google Scholar]
  • 15.Risom SS, Lind J, McCabe PJ, Berg SK. Patient perspectives of participating in the cardiac CopenHeartRFA rehabilitation program for patients treated with ablation for atrial fibrillation. J Multidiscip Healthc. 2018;11:167–74. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16.Anderson L, Sharp GA, Norton RJ, Dalal H, Dean SG, Jolly K, et al. Home-based versus centre-based cardiac rehabilitation. The Cochrane database of systematic reviews. 2017;6(6):Cd007130. [DOI] [PMC free article] [PubMed]
  • 17.Royal College of Nursing. Moving care to the community: an international perspective. 2012.
  • 18.Risom SS. Danish national clinical guideline for rehabilitation in patients with atrial fibrillation, atrial flutter, patients wit endocarditis and patients treated with an ImplanTable Cardioverter Defibrillator (ICD). Copenhagen: Center for Heart, Vascular, Lung and Infectious Diseases, Rigshospitalet; 2019. [Google Scholar]
  • 19.Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2024;149(1):e1-e156. [DOI] [PMC free article] [PubMed]
  • 20.The Danish Health Authority. Danish national clinical guideline for cardiac rehabilitation 2013. Copenhagen: Danish Health Authority; 2015. [Google Scholar]
  • 21.Gallagher C, Hendriks JM, Middeldorp ME, Elliott AD, Lau DH, Sanders P. Reducing the burden of atrial fibrillation cost: is integrated care the answer? Can J Cardiol. 2019;35(9):1094–6. [DOI] [PubMed] [Google Scholar]
  • 22.Gallagher C, Elliott AD, Wong CX, Rangnekar G, Middeldorp ME, Mahajan R, et al. Integrated care in atrial fibrillation: a systematic review and meta-analysis. Heart. 2017;103(24):1947–53. [DOI] [PubMed] [Google Scholar]
  • 23.Hendriks JM, Heidbüchel H. The management of atrial fibrillation: an integrated team approach - insights of the 2016 European Society of Cardiology guidelines for the management of atrial fibrillation for nurses and allied health professionals. Eur J Cardiovasc Nurs. 2019;18(2):88–95. [DOI] [PubMed] [Google Scholar]
  • 24.Ski CF, Cartledge S, Foldager D, Thompson DR, Fredericks S, Ekman I, et al. Integrated care in cardiovascular disease: a statement of the Association of Cardiovascular Nursing and Allied Professions of the European Society of Cardiology. Eur J Cardiovasc Nurs. 2023;22(5):e39–46. [DOI] [PubMed] [Google Scholar]
  • 25.Wahlstrom M, Rosenqvist M, Medin J, Walfridsson U, Rydell-Karlsson M. MediYoga as a part of a self-management programme among patients with paroxysmal atrial fibrillation - a randomised study. Eur J Cardiovasc Nurs. 2019. 10.1177/1474515119871796. [DOI] [PubMed] [Google Scholar]
  • 26.Wahlstrom M, Rydell Karlsson M, Medin J, Frykman V. Effects of yoga in patients with paroxysmal atrial fibrillation - a randomized controlled study. Eur J Cardiovasc Nurs. 2017;16(1):57–63. [DOI] [PubMed] [Google Scholar]
  • 27.Murugesan M, Taylor AG. Effect of yoga on the autonomic nervous system: clinical implications in the management of atrial fibrillation. Journal of Yoga and Physiotherapy. 2017;2(5):001–0017. [Google Scholar]
  • 28.Augsburg JB, Dar MI, Wood K, Rasmussen TB, Risom SS. A systematic literature review of the effect of mind-body interventions on mental health among patients with atrial fibrillation. Mental Health & Prevention. 2022;28:200245. [Google Scholar]
  • 29.Wahlström M, Karlsson MR, Medin J. Perceptions and experiences of MediYoga among patients with paroxysmal atrial fibrillation—an interview study. Complement Ther Med. 2018;41:29–35. [DOI] [PubMed] [Google Scholar]
  • 30.Creswell JW, Clark VLP. Designing and conducting mixed methods research. 3rd ed. Los Angeles: SAGE Publications; 2018. [Google Scholar]
  • 31.Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ - RESEARCH METHODS AND REPORTING. 2016;355:i5239. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 32.Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot and Feasibility Studies. 2019;5(114). [DOI] [PMC free article] [PubMed]
  • 33.Wynn GJ, Todd DM, Webber M, Bonnett L, McShane J, Kirchhof P, et al. The European Heart Rhythm Association symptom classification for atrial fibrillation: validation and improvement through a simple modification. Europace. 2014;16:965–72. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 34.The Danish Health Authority. Alcohol prevention 2018 [Available from: https://sst.dk/-/media/Udgivelser/2018/Forebyggelsespakker/Alkohol.ashx.
  • 35.The Danish Health Authority. Recommendations for physical activity for adults +65 years 2019 [Available from: https://www.sst.dk/da/viden/Forebyggelse/Fysisk-aktivitet/Anbefalinger-om-fysisk-aktivitet/_65-aarige.
  • 36.Chung F, Abdullah HR, Liao P. STOP-bang questionnaire: a practical approach to screen for obstructive sleep apnea. Chest. 2016;149(3):631–8. [DOI] [PubMed] [Google Scholar]
  • 37.Lemay KR, Tulloch HE, Pipe AL, Reed JL. Establishing the minimal clinically important difference for the Hospital Anxiety and Depression Scale in patients with cardiovascular disease. J Cardiopulm Rehabil Prev. 2019;39(6):E6-e11. [DOI] [PubMed] [Google Scholar]
  • 38.European Society of Cardiology. Mental vulnerability associated with increased risk of fatal and non-fatal cardiovascular disease independently of classical risk factors - Predictive ability is less clearly defined: European Society of Cardiology; 2013 [Available from: https://www.escardio.org/The-ESC/Press-Office/Press-releases/Mental-vulnerability-associated-with-increased-risk-of-fatal-and-non-fatal-cardi.
  • 39.Borglykke A, Ebstrup J, Jørgensen T, et al. Mental vulnerability as a predictor of cardiovascular disease and death: Presented at EuroPRevent 2013 congress. Final Programme Number P52; 2013 [Available from: https://liguecardioliga.be/actualiteit/.
  • 40.Eplov LF, Jørgensen T, Birket-Smith M, Petersen J, Johansen C, Mortensen EL. Mental vulnerability—a risk factor for ischemic heart disease. J Psychosom Res. 2006;60(2):169–76. [DOI] [PubMed] [Google Scholar]
  • 41.Ministry of Health. Healthcare in Denmark - An overview: Ministry of Health; 2017 [Available from: https://sum.dk/Media/C/A/Healthcare-in%20denmark%20an%20overview%20english-V16-dec.pdf.
  • 42.Local government Svendborg. Healthcare Center Svendborg 2024 [Available from: https://sundhed.svendborg.dk/sundhedshus-svendborg.
  • 43.The Danish Health Authority. Recommendations for prevention services in citizens with chronic diseases. Copenhagen: Danish Health Authority; 2016. [Google Scholar]
  • 44.Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021. [DOI] [PMC free article] [PubMed]
  • 45.The Danish Health Authority. Recommendations for cross-sectoral health services in individuals with cardiac diseases. Copenhagen: Danish Health Authority; 2018. [Google Scholar]
  • 46.Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom clinical research network database. BMC Med Res Methodol. 2013;13:104. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 47.Ramboll. Xact by Ramboll 2024 [Available from: https://rambollxact.dk/.
  • 48.Kristensen MS, Zwisler A, Berg SK, Zangger G, Grønset CN, Risom SS, et al. Validating the HeartQoL questionnaire in patients with atrial fibrillation. Preventive Cardiology. 2016;0(00):1–8. [DOI] [PubMed]
  • 49.Rasmussen TB, Palm P, Herning M, Christensen AV, Borregaard B, Nielsen KSG, et al. Subgroup differences and determinants of patient-reported mental and physical health in patients with ischemic heart disease: results from the denheart study. J Cardiovasc Nurs. 2019;34(4):E11–21. [DOI] [PubMed] [Google Scholar]
  • 50.Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. [Google Scholar]
  • 51.Lumivero. About NVivo 2024 [Available from: https://help-nv.qsrinternational.com/20/win/Content/about-nvivo/about-nvivo.htm.
  • 52.Guetterman TC, Fetters MD, Creswell JW. Integrating quantitative and qualitative results in health science mixed methods research through joint displays. Ann Fam Med. 2015;13(6):554–61. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 53.Mills M, Johnson E, Zafar H, Horwood A, Lax N, Charlesworth S, et al. An exercise-based cardiac rehabilitation programme for AF patients in the NHS: a feasibility study. Br J Cardiol. 2020;27(2):20. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 54.Zhao K, Fu Z, Wang F, Wei X, Che X. Effects of nurse-led interventions on comprehensive rehabilitation of atrial fibrillation: a systematic review and meta-analysis. Altern Ther Health Med. 2024;30(1):36–43. [PubMed] [Google Scholar]
  • 55.Ashburner JM, Carmichael TD, Bhattacharya R, Bapat AC, Natarajan P, Atlas SJ, et al. A Lifestyle Modification Program for Secondary Prevention of Atrial Fibrillation: A Pilot Study. Res Sq. 2023. [DOI] [PMC free article] [PubMed]
  • 56.Buckley BJR, Risom SS, Boidin M, Lip GYH, Thijssen DHJ. Atrial fibrillation specific exercise rehabilitation: are we there yet? J Pers Med. 2022;12(4):610. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 57.Pastori D, Farcomeni A, Pignatelli P, Violi F, Lip GY. ABC (Atrial fibrillation Better Care) pathway and healthcare costs in atrial fibrillation: the ATHERO-AF study. Am J Med. 2019;132(7):856–61. [DOI] [PubMed] [Google Scholar]
  • 58.Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van ’t Hof A, Meindersma E, et al. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016;223:436–43. [DOI] [PubMed] [Google Scholar]
  • 59.Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102–9. [DOI] [PubMed] [Google Scholar]
  • 60.Pedersen M, Bennich B, Boateng T, Beck AM, Sibilitz K, Andersen I, et al. Peer-mentor support for older vulnerable myocardial infarction patients referred to cardiac rehabilitation: single-arm feasibility study. Pilot Feasibility Stud. 2022;8(1):172. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 61.de Figueiredo M, Giannoukos S, Wüthrich C, Zenobi R, Rutledge DN. A tutorial on the analysis of multifactorial designs from one or more data sources using AComDim. J Chemometrics. 2023;37(7):e3384. [Google Scholar]
  • 62.Seligman WH, Das-Gupta Z, Jobi-Odeneye AO, Arbelo E, Banerjee A, Bollmann A, et al. Development of an international standard set of outcome measures for patients with atrial fibrillation: a report of the International Consortium for Health Outcomes Measurement (ICHOM) atrial fibrillation working group. Eur Heart J. 2020;41(10):1132–40. [DOI] [PMC free article] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Additional file 1. (230.5KB, doc)
Additional file 2. (182.6KB, pdf)
Additional file 3. (182.2KB, pdf)
Additional file 4. (280.5KB, pdf)
Additional file 5. (15.6KB, docx)

Data Availability Statement

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

Articles from Pilot and Feasibility Studies are provided here courtesy of BMC

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