Effects of a Nurse‐Led Common‐Sense Model of Self‐Regulation‐Based Heart Failure Self‐Care Program on Patient Outcomes: A Randomized Controlled Trial

Abstract

Background

Inadequate self‐care is reported among people with heart failure (HF), contributing to poor prognosis. Nurse‐led HF self‐care interventions underpinned by the Common‐Sense Model of Self‐Regulation may promote behavior change and improve health outcomes; however, their effectiveness has yet to be established.

Methods

A randomized controlled trial was conducted at a hospital in China from March to August 2023. Patients with HF were randomly assigned to either the intervention or control group (N=69 per group). Participants in the intervention group received a 6‐week, nurse‐led Common‐Sense Model of Self‐Regulation‐based HF self‐care program in addition to usual care, whereas the control group received only usual care. The primary outcomes were illness perceptions and self‐care behaviors and secondary outcomes included self‐care self‐efficacy, health‐related quality of life, depression, anxiety, symptom burden, sleep quality, health care service use, and mortality. Data were collected at baseline, 6 weeks (T1), and 3 months (T2) after enrollment. Intervention effects were estimated using generalized estimating equations or the Mann–Whitney U test.

Results

Of the 138 participants, 97 (70.3%) were male, and the mean±SD age was 63.95 (11.91) years. Participants in the intervention group revealed significant improvements in illness perceptions, self‐care behaviors, self‐care self‐efficacy, health‐related quality of life, depression, symptom burden, and sleep quality compared with the control group at T1 and T2. The intervention group also demonstrated a significant reduction in the number of HF‐related unscheduled outpatient department visits at T2.

Conclusions

This care model was effective in promoting behavior change and improving health outcomes among patients with HF during vulnerable phases of the condition.

Registration

URL: https://www.chictr.org; Unique Identifier: ChiCTR2300067270.

Nonstandard Abbreviations and Acronyms

CSM

Common‐Sense Model

HRQOL

health‐related quality of life

Clinical Perspective.

What Is New?

• This program was effective in improving illness perceptions, self‐care behaviors, self‐care self‐efficacy, health‐related quality of life, depression, symptom burden, and sleep quality, and reducing the number of heart failure‐related outpatient department visits among people with heart failure.

What Are the Clinical Implications?

• Nurse‐led self‐care services can effectively support patients during vulnerable phases of heart failure.

Heart failure (HF) is widely recognized as a significant global health care challenge, affecting an estimated 64.3 million individuals all over the world. ¹ , ² About 6.7 million Americans aged 20 and older have HF, and the prevalence is projected to reach 8.7 million by 2030. ³ In China, a large‐scale study including 50 million individuals aged 25 years and older revealed an HF prevalence of 1.1%, equating to ∼12.1 million people. ⁵ High mortality rates, ⁴ , ⁵ frequent hospitalizations, ⁴ , ⁵ depression, ⁶ anxiety, ⁷ symptom burden, ⁸ sleep problems, ⁹ and reduced health‐related quality of life (HRQOL) ¹⁰ , ¹¹ were usually observed in people with HF. Self‐care is an indispensable strategy for HF management, ¹² , ¹³ , ¹⁴ but its uptake among this clinical cohort remains suboptimal. ¹⁵ , ¹⁶ , ¹⁷ , ¹⁸ , ¹⁹ Our prior systematic review indicated that nurse‐led self‐care interventions may hold promise in improving self‐care maintenance, self‐care management, self‐care self‐efficacy, HRQOL, depression, anxiety, and symptom burden among patients with HF. ²⁰ , ²¹

Interventions that modify significant predictors of self‐care behaviors are crucial to promoting the uptake of self‐care practices, thereby improving patient prognosis. The Common‐Sense Model (CSM) of Self‐Regulation and existing evidence indicate that illness perceptions are key determinants of self‐care behaviors and health outcomes among people with HF. ²² , ²³ , ²⁴ , ²⁵ , ²⁶ , ²⁷ This model posits that individuals facing health threats develop illness perceptions, which influence their disease outcomes directly or indirectly, with the latter having coping procedures as mediators. ²³ Illness perceptions are central to the model and are categorized into cognitive and emotional perceptions. ²³ Cognitive perceptions include identity, timeline, consequences, personal control, treatment control, illness coherence, and cause, which are assumed to modulate objective health risks. ²³ In contrast, emotional perceptions are viewed as adjusters of negative emotions. ²³ Coping procedures are specific behaviors or strategies that individuals undertake in response to health threats. ²³ It has been reported that inaccurate illness perceptions are prevalent in Chinese patients with HF. ²⁶ , ²⁸ An unclear understanding of their diagnosis, a lack of knowledge in recognizing symptoms and signs of HF, and insufficient experience combined with misconceptions in interpreting the significance of worsening conditions can significantly affect patients’ causal belief and illness identity, contributing to delays in seeking care and confusion regarding treatment intentions. ²⁹ , ³⁰ The chronic and cyclical nature of HF, together with its severe physical, emotional, and social consequences, has a negative impact on patients’ coping procedures and prognosis. ²⁹ , ³⁰ Individuals living with HF also report decreased confidence in their ability to maintain a stable health status and make informed decisions about their care, as well as in the effectiveness of the therapies. ²⁹ Perceived low controllability over their conditions is related to poor adherence to self‐care and treatment regimens, resulting in negative health outcomes. ²⁹ , ³⁰ In addition, the investigators have shown that patients experience great emotional responses, including feelings of disappointment and hopelessness stemming from uncertainty about their illness, and a sense of loss regarding their independence and physical capacities. ²⁹ The model also suggests the moderating role of self‐efficacy between illness perceptions and coping behaviors. ²³ , ³¹ Therefore, drawing on this model, illness perceptions and self‐efficacy emerge as critical targets to prioritize in the design of effective nurse‐led self‐care interventions for individuals with HF.

Empirical research underpinned by the CSM of Self‐Regulation has demonstrated its effects in improving health behaviors and patient outcomes across various disease contexts, ²⁷ , ³² , ³³ , ³⁴ , ³⁵ , ³⁶ , ³⁷ but evidence on HF is insufficient and inconsistent. ²⁷ , ³⁷ Previous education interventions for HF are limited by neglect of the emotional aspects of illness perceptions and failure to incorporate behavior change techniques when designing interventions, ²⁷ , ³⁷ methodological flaws, ²⁷ and inadequate measurement of important outcomes including symptom burden, sleep quality, depression, anxiety, health care service use, and mortality. ²⁷ , ³⁷ Therefore, additional studies are warranted to bridge these knowledge gaps. Moreover, our prior systematic reviews have identified certain limitations in the existing nurse‐led HF self‐care interventions, including methodological shortcomings, absence or unclear descriptions of the relationship between intervention content and adopted theories, and insufficient evidence of the intervention effects on certain patient outcomes. ²⁰ , ²¹

To address these research gaps, we conducted a robust randomized controlled trial to examine the effects of a nurse‐led CSM of Self‐Regulation‐based self‐care program on illness perceptions, self‐care self‐efficacy, self‐care behaviors, HRQOL, depression, anxiety, symptom burden, sleep quality, health care service use, and mortality among Chinese people with HF. The findings provide insights for nurse‐led HF services in China and beyond.

METHODS

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Study Design

This single‐blind, 2‐arm, parallel‐group randomized controlled trial with repeated measurement was conducted at a hospital in China from March to August 2023 (ChiCTR2300067270). Ethical approval was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee. Participants endorsed written informed consent. The study followed the Consolidated Standards of Reporting Trials reporting guideline.

Study Participants

Participants were enrolled consecutively using convenience sampling. The researcher identified potential participants by reviewing their electronic medical records. Following this, the eligibility of the patients was assessed according to the inclusion and exclusion criteria. The researcher approached the identified patients in person at their bedside to evaluate their willingness to participate in the program, providing each individual with an informed consent form and elaborating its details. If the patients agreed to participate in the study, they were required to endorse the informed consent form, and then a card containing the contact information of the research team was provided to each patient. The inclusion criteria were (1) adults (ages ≥ 18 years); (2) diagnosed with HF; (3) classified as New York Heart Association functional class I‐IV; (4) able to complete the questionnaire; (5) able to communicate in Mandarin or Cantonese; (6) available for telephone follow‐up; and (7) willing to participate in the study. Patients were excluded if they had psychiatric disorders, severe physical illnesses, or had recently participated in other clinical trials.

Referring to our prior systematic review, the pooled effect sizes of nurse‐led self‐care interventions for illness perceptions, self‐care maintenance, and self‐care management are 2.01, 0.71, and 0.70, respectively. ²⁰ Using the G*Power 3.1 statistical software, ³⁸ it is estimated that 128 participants are needed to detect a 2‐sided significant difference between groups at a conservative estimate of effect size of 0.50 with a sufficient power of 0.8 at a significance level of 0.05. Given the attrition rate of 7.0%, ²⁷ , ³⁹ , ⁴⁰ , ⁴¹ , ⁴² , ⁴³ at least 138 patients with HF were required for this study.

Randomization and Blinding

Participants were randomly assigned in a 1:1 ratio to either the intervention (nurse‐led CSM of Self‐Regulation‐based HF self‐care program plus usual care) or the control group (usual care only) using block randomization with block sizes of 4 or 6. Randomization and allocation concealment were handled by an independent researcher. A list of the permuted block sequence of 2 group labels was generated using an online tool (https://www.sealedenvelope.com/). The allocation sequence was concealed using sequentially numbered opaque sealed envelopes. The outcome assessor responsible for posttest data collection was blinded.

Nurse‐Led CSM of Self‐Regulation‐Based HF Self‐Care Program

The 6‐week, nurse‐led CSM of Self‐Regulation‐based HF self‐care program consists of 1 60‐minute face‐to‐face individual education session in the hospital (week 1) followed by 1 20‐minute reinforcement telephone follow‐up session in the first week after discharge (week 2) and then 2 20‐minute biweekly (week 4 and week 6) reinforcement telephone follow‐up sessions. Participants were provided with education handbooks and self‐care logbooks. The intervention was delivered by the same intervener in accordance with the study protocol. We summarized the details of this program in Table 1. The development and pilot testing of the program have been published elsewhere. ⁴⁴ The education handbook contains the disease‐related knowledge (information on the definition, causes, clinical manifestations, physical and psychological impacts, course of HF, and on treatments for HF), self‐care knowledge and skills training (medication management, fluid management, nutrition management, exercise and rehabilitation management, smoking cessation, alcohol restriction and abstinence, emotional management, sleep management, leisure and entertainment, immunization and prevention of infections, and symptom monitoring, recognition, and management), and behavior change techniques (problem‐solving, decision‐making, goal‐setting, and action‐planning). Details are presented in Table S1. The self‐care logbook included structured forms (a goal‐setting and action‐planning record sheet, a problem‐solving skills practice sheet, a medication list, a health record sheet, an exercise record sheet, and a fluid intake record sheet) to help participants adhere to self‐care. ⁴⁴

Table 1.

Outline of the Nurse‐Led Common‐Sense Model of Self‐Regulation‐Based HF Self‐Care Program

Week	Themes	Goals	Contents
1	Discharge education on HF self‐care	(1) To assist participants in developing accurate perceptions of HF and confidence in self‐care (2) To emphasize the significance of self‐care while equipping participants with essential self‐care knowledge and skills (3) To facilitate self‐care among participants	Implement individual assessments of the participants’ illness perceptions Identify inaccurate perceptions of HF and provide information via education handbook to establish accurate illness perceptions Emphasize the significance of self‐care and perform individual assessments of the participants’ self‐care self‐efficacy and self‐care behaviors Identify problems with self‐care and use the education handbook to provide the participants with self‐care knowledge and skills training to enhance self‐care self‐efficacy and self‐care behaviors Teach the participants how to use problem‐solving skill to make decisions on managing individual self‐care problems using education handbook and self‐care logbook Guide the participants on how to establish self‐care goals and action plans using education handbook and self‐care logbook
2, 4, and 6	Reinforcement telephone follow‐up	(1) To assess and monitor the participants’ self‐care performance (2) To reinforce the significance of self‐care practices (3) To encourage and support participants in their self‐care	Review participants’ goal achievement Provide positive feedback on the participants’ efforts to adhere to self‐care Point out any discrepancies between current behaviors and goals Discuss barriers to and problems in implementing self‐care Encourage the participants to continue to use problem‐solving skills to make decisions in managing individual self‐care problems Encourage the participants to continue following action plans and working toward goals or to modify these, as appropriate Remind participants to use the education handbook and self‐care logbook

HF indicates heart failure.

Usual Care

The usual care contains standard medical services provided by physicians, nurses, and therapists. These services encompass routine treatment, nursing care, discharge instruction, and 1 telephone follow‐up during the first week after the patient is discharged from the hospital.

Intervention Fidelity

In our study, we ensured intervention fidelity by adhering to the recommendations from the National Institutes of Health Behavior Change Consortium, which focuses on 5 areas: study design, training provider, delivery of treatment, receipt of treatment, and enactment of treatment. ⁴⁵ A checklist was created to ensure that the intervention aligned with the theoretical framework, and a detailed intervention protocol outlining the treatment dosage was also developed. The intervention was administered by the same intervener according to the established study protocol to maintain consistency. The intervener is the first author, a registered nurse and nursing researcher specializing in HF self‐care and behavior research. To monitor and enhance intervention receipt, the intervener reiterated the program’s objectives at the beginning of each session. Additionally, the intervener employed the teach‐back method to confirm that participants had effectively acquired the necessary self‐care knowledge and skills. Participants were provided with educational handbooks and self‐care logbooks to facilitate their self‐care practices. The intervener conducted assessments and provided feedback on participants’ progress toward predefined goals and the application of relevant skills.

Data Collection and Outcomes Measures

Data collection was conducted at baseline (T0), 6 weeks (T1, primary time point), and 3 months (T2) after enrollment. Data on health care service use and mortality were collected only at T1 and T2. The primary outcomes were illness perceptions (measured using the 9‐item Brief Illness Perception Questionnaire) ⁴⁶ , ⁴⁷ and self‐care behaviors (measured using the 29‐item Self‐Care of Heart Failure Index version 7.2). ⁴⁸ , ⁴⁹ The secondary outcomes included self‐care self‐efficacy, HRQOL, depression, anxiety, symptom burden, sleep quality, health care service use, and mortality, which were obtained using the Self‐Care Self‐Efficacy Scale, ⁵⁰ , ⁵¹ the Minnesota Living with Heart Failure Questionnaire, ⁵² , ⁵³ the Patient Health Questionnaire, ⁵⁴ , ⁵⁵ the Generalized Anxiety Disorder, ⁵⁶ , ⁵⁷ the Memorial Symptom Assessment Scale–Heart Failure, ⁵⁸ , ⁵⁹ the Pittsburgh Sleep Quality Index, ⁶⁰ , ⁶¹ and a self‐designed table, respectively. In addition, we collected participants’ sociodemographic and disease‐related information. Detailed descriptions of each outcome measure can be found in Table S2.

Statistical Analysis

Statistical analyses were conducted using IBM SPSS version 27.0. A 2‐sided P < 0.05 was considered statistically significant. The significance level for the primary outcomes was set at 0.0125, considering 4 primary outcomes in this study. Descriptive statistics were used to summarize participant characteristics. The normality of continuous variables was examined by quantile‐quantile plots, along with skewness and kurtosis statistics. ⁶² , ⁶³ We assessed the homogeneity of the participants’ baseline data between 2 groups using the independent t test, Mann–Whitney U test, chi‐square test, and Fisher’s exact test, as appropriate. Generalized estimating equations with a first‐order autoregressive working correlation structure were used to examine the interaction (Group*Time) treatment effects in terms of differential changes in outcome variables, including illness perceptions, self‐care behaviors, self‐care self‐efficacy, HRQOL, depression, anxiety, symptom burden, and sleep quality across time points between the study groups. In the generalized estimating equations analysis, a linear scale response was selected, and the model included the group, time point (T1 and T2), and the group‐by‐time point interaction (Group*T1 and Group*T2), with the control group and T0 set as reference levels. The regression coefficients for group represent the mean baseline difference between the study groups, where those for T1 and T2 refer to the mean changes in the outcomes in the control group at T1 and T2 relative to T0. The regression coefficients for Group*T1 and Group*T2 indicate the additional increments in the outcomes at T1 and T2 relative to T0 in the intervention group compared with the control group. Missing data were handled by the quasi‐likelihood method in generalized estimating equations analysis. The Little missing completely at random tests showed that the data were missing completely at random. The results of health care service use were presented as means and ranges due to the small number of cases included. Mann–Whitney U test (where U is the test statistic) was used to compare the differences in health care service use between the intervention and the control groups at T1 and T2. As the overall attrition rate was minimal, the health care service use outcomes were compared between groups based on complete cases.

RESULTS

A total of 175 patients with HF were screened for eligibility. Of these, 138 participants consented to take part in the study and were randomly allocated to either the intervention group (n=69) or the control group (n=69). The study was completed by 133 participants, yielding an overall attrition rate of 3.6% (1.4% in the intervention group and 5.8% in the control group) (Figure). The mean age of participants was 63.95 years (SD=11.91), of whom 70.3% were male. Detailed baseline data of the participants are presented in Table 2. No significant differences were noted in baseline data between the intervention and control groups nor between completers and noncompleters.

Figure 1. Consolidated Standards of Reporting Trials flow chart for participants in the study.

Table 2.

Baseline Data of Participants

Characteristics	Total (n=138)	Control (n=69)	Intervention (n=69)
	Mean±SD/n (%)/median (P25, P75)	Mean±SD/n (%)/median (P25, P75)	Mean±SD/n (%)/median (P25, P75)
Sociodemographic characteristics
Age, y	63.95±11.91	64.74±12.18	63.19±11.67
Sex
Male	97 (70.3)	52 (75.4)	45 (65.2)
Female	41 (29.7)	17 (24.6)	24 (34.8)
Marital status
Married	134 (97.1)	66 (95.7)	68 (98.6)
Single/divorced/separated/widowed	4 (2.9)	3 (4.3)	1 (1.4)
Educational level
Primary or less	40 (29.0)	23 (33.3)	17 (24.6)
Secondary	77 (55.8)	38 (55.1)	39 (56.5)
Tertiary or above	21 (15.2)	8 (11.6)	13 (18.9)
Employment status
Employed	25 (18.1)	10 (14.5)	15 (21.7)
Unemployed	113 (81.9)	59 (85.5)	54 (78.3)
Place of residence
Urban	73 (52.9)	33 (47.8)	40 (58.0)
Rural	65 (47.1)	36 (52.2)	29 (42.0)
Living arrangement
Living alone	7 (5.1)	3 (4.3)	4 (5.8)
Living with others	131 (94.9)	66 (95.7)	65 (94.2)
Smoking history
No	84 (60.9)	40 (58.0)	44 (63.8)
Ex‐smoker	22 (15.9)	13 (18.8)	9 (13.0)
Smoking	32 (23.2)	16 (23.2)	16 (23.2)
Drinking history
No	100 (72.5)	46 (66.7)	54 (78.3)
Ex‐drinker	14 (10.1)	8 (11.6)	6 (8.7)
Drinking	24 (17.4)	15 (21.7)	9 (13.0)
Clinical characteristics
Cause of heart failure
Coronary artery disease	60 (43.5)	33 (47.8)	27 (39.1)
Cardiomyopathy	38 (27.5)	15 (21.7)	23 (33.3)
Valvular heart disease	58 (42.0)	25 (36.2)	33 (47.8)
Arrhythmias	50 (36.2)	26 (37.7)	24 (34.8)
Hypertension	53 (38.4)	31 (44.9)	22 (31.9)
Infection	12 (8.7)	7 (10.1)	5 (7.2)
Diabetes	40 (29.0)	24 (34.8)	16 (23.2)
Hyperthyroidism	4 (2.9)	3 (4.3)	1 (1.4)
Hyperlipidemia	12 (8.7)	6 (8.7)	6 (8.7)
Anemia	1 (0.7)	1 (1.4)	0 (0.0)
Number of hospitalization (time)	2.67±1.36	2.84±1.40	2.49±1.30
Duration of diagnosis (month)	1.00 (1.00, 9.00)	1.00 (1.00, 12.00)	1.00 (1.00, 9.00)
Left ventricular ejection fraction, %	42.49±16.51	44.14±15.29	40.84±17.60
New York Heart Association functional classification
Class I to II	54 (39.1)	23 (33.3)	31 (44.9)
Class III to IV	84 (60.9)	46 (66.7)	38 (55.1)
Charlson Comorbidity Index	3.79±1.63	4.00±1.74	3.58±1.49
Body mass index, kg/m2	23.30±3.30	23.26±3.31	23.34±3.32
Systolic blood pressure, mm Hg	117.40±19.72	117.28±21.15	117.52±18.33
Diastolic blood pressure, mm Hg	72.25±13.73	70.81±13.64	73.70±13.77
Heart rate, beats per min	81.59±16.94	79.25±17.63	83.94±16.00
N‐terminal pro‐B‐type natriuretic peptide, pg/mL	2412.50 (1032.25–6822.75)	2748.00 (1028.50–7515.00)	2382.00 (1028.00–6713.00)
Total cholesterol, mmol/L	4.05±1.15	3.93±1.27	4.16±1.02
Triglyceride, mmol/L	1.10 (0.83–1.44)	1.11 (0.79–1.37)	1.08 (0.84–1.55)
High‐density lipoprotein, mmol/L	0.95 (0.85–1.15)	0.94 (0.85–1.11)	1.02 (0.85–1.20)
Low‐density lipoprotein, mmol/L	2.48±0.81	2.42±0.92	2.55±0.70
Urea, mmol/L	7.45 (5.68–9.90)	8.00 (5.75–10.30)	7.00 (5.65–9.15)
Creatinine, mmol/L	94.00 (71.00–116.00)	94.00 (75.50–119.50)	95.00 (67.00–112.00)
Glycated hemoglobin, %	5.97 (5.56–6.78)	6.13 (5.58–6.88)	5.94 (5.55–6.47)
Medications
Angiotensin receptor blocker	1 (0.7)	1 (1.4)	0 (0.0)
Angiotensin receptor neprilysin inhibitor	115 (83.3)	59 (85.5)	56 (81.2)
Beta blocker	108 (78.3)	51 (73.9)	57 (82.6)
MRA	102 (73.9)	53 (76.8)	49 (71.0)
Sodium‐glucose cotransporter‐2 inhibitors	101 (73.2)	53 (76.8)	48 (69.6)
Diuretics (excluding MRA)	117 (84.8)	58 (84.1)	59 (85.5)
Statin	110 (79.7)	56 (81.2)	54 (78.3)
Digitalis	19 (13.8)	10 (14.5)	9 (13.0)
Frailty	4.62±1.62	4.81±1.62	4.42±1.61
Outcome variables
Illness perceptions	45.89±8.58	46.71±8.17	45.07±8.94
Self‐care self‐efficacy	34.64±12.40	34.49±12.87	34.78±12.01
Self‐care behaviors
Self‐care maintenance	22.45±8.51	21.70±8.46	23.19±8.55
Symptom perception	21.72±11.86	21.05±11.14	22.40±12.59
Self‐care management	42.89±10.69	41.41±10.66	44.36±10.66
Health‐related quality of life	41.53±11.47	42.96±11.12	40.10±11.71
Depression	4.83±2.72	4.97±2.68	4.69±2.77
Anxiety	4.30±2.88	4.59±2.69	4.01±3.05
Symptom burden	0.61±0.28	0.62±0.27	0.60±0.30
Sleep quality	12.42±3.79	12.65±3.64	12.20±3.96

MRA indicates mineralocorticoid receptor antagonist.

Primary Outcomes

Compared with the control group, participants in the intervention group exhibited greater improvements in illness perceptions at T1 (β, −15.75 [95% CI, −18.16 to −13.34], P < 0.001) and T2 (β, −17.32 [95% CI, −20.10 to −14.53], P < 0.001). Participants in the intervention group also demonstrated significantly greater improvements in self‐care maintenance (T1: β, 16.67 [95% CI, 14.05− 19.28], P < 0.001; T2: β, 21.72 [95% CI, 18.84− 24.59], P < 0.001), symptom perception (T1: β, 24.44 [95% CI, 20.86− 28.02], P < 0.001; T2: β, 30.34 [95% CI, 26.27− 34.41], P < 0.001), and self‐care management (T1: β, 21.33 [95% CI, 18.07− 24.59], P < 0.001; T2: β, 27.29 [95% CI, 23.50− 31.07], P < 0.001) than those in the control group (Table 3). The differences in self‐care behavior scores between the study groups at both T1 and T2 also indicated that a minimal clinically important difference was achieved.

Table 3.

Generalized Estimating Equation Models for the Comparison of Each Outcome Across Time Between the Study Groups

Outcome	Time point	Intervention group	Control group	Group effect		Time effect		Group×time effect
				β (95% CI)	P value	β (95% CI)	P value	β (95% CI)	P value
Illness perceptions	T0	45.07±8.94	46.71±8.17	−1.64 (−4.48 to 1.20)	0.258
	T1	22.01±7.90	39.28±9.78			−7.28 (−8.77 to −5.79)	<0.001	−15.75 (−18.16 to −13.34)	<0.001
	T2	17.81±7.24	36.62±10.11			−9.98 (−11.81 to −8.15)	<0.001	−17.32 (−20.10 to −14.53)	<0.001
Self‐care maintenance	T0	23.19±8.55	21.70±8.46	1.49 (−1.33 to 4.30)	0.302
	T1	52.02±7.22	33.58±5.80			12.16 (10.39 to 13.93)	<0.001	16. 67 (14.05 to 19.28)	<0.001
	T2	56.25±6.86	32.88±5.54			11.34 (9.40 to 13.29)	<0.001	21.72 (18.84 to 24.59)	<0.001
Symptom perception	T0	22.40±12.59	21.05±11.14	1.36 (−2.58 to 5.29)	0.500
	T1	62.67±8.03	36.51±8.52			15.82 (13.59 to 18.05)	<0.001	24.44 (20.86 to 28.02)	<0.001
	T2	65.61±8.93	33.72±9.29			12.87 (10.36 to 15.38)	<0.001	30.34 (26.27 to 34.41)	<0.001
Self‐care management	T0	44.36±10.66	41.41±10.66	2.94 (−0.58 to 6.46)	0.101
	T1	77.73±7.24	53.38±9.64			12.06 (9.75 to 14.36)	<0.001	21.33 (18.07 to 24.59)	<0.001
	T2	85.52±7.06	55.20±8.61			13.84 (11.38 to 16.30)	<0.001	27.29 (23.50 to 31.07)	<0.001
Self‐care self‐efficacy	T0	34.78±12.01	34.49±12.87	0.29 (−3.83 to 4,41)	0.890
	T1	74.02±9.84	47.38±8.99			13.21 (10.95 to 15.47)	<0.001	26.05 (22.50 to 29.60)	<0.001
	T2	80.92±9.36	48.58±9.25			14.27 (12.04 to 16.50)	<0.001	31.78 (28.07 to 35.48)	<0.001
Health‐related quality of life	T0	40.10±11.71	42.96±11.12	−2.86 (−6.64 to 0.93)	0.139
	T1	10.50±6.46	21.77±9.64			−21.03 (−23.29 to −18.76)	<0.001	−8.72 (−12.06 to −5.37)	<0.001
	T2	5.99±3.85	17.97±9.49			−24.90 (−27.31 to −22.49)	<0.001	−9.29 (−12.82 to −5.77)	<0.001
Depression	T0	4.69±2.77	4.97±2.68	−0.28 (−1.18 to 0.63)	0.550
	T1	0.74±0.95	2.88±2.17			−2.08 (−2.58 to −1.58)	<0.001	−1.89 (−2.65 to −1.13)	<0.001
	T2	0.69±1.48	2.26±2.22			−2.70 (−3.31 to −2.10)	<0.001	−1.32 (−2.17 to −0.46)	<0.001
Anxiety	T0	4.01±3.05	4.59±2.69	−0.58 (−1.53 to 0.37)	0.232
	T1	1.01±1.54	1.98±2.15			−2.57 (−3.14 to −1.99)	<0.001	−0.46 (−1.23 to 0.32)	0.248
	T2	0.41±0.92	1.15±1.66			−3.42 (−4.01 to −2.83)	<0.001	−0.20 (−1.09 to 0.70)	0.669
Symptom burden	T0	0.60±0.30	0.62±0.27	−0.023 (−0.12 to 0.07)	0.602
	T1	0.08±0.07	0.24±0.16			−0.38 (−0.42 to −0.33)	<0.001	−0.14 (−0.22 to −0.06)	<0.001
	T2	0.05±0.07	0.20±0.14			−0.42 (−0.47 to −0.37)	<0.001	−1.12 (−0.21 to −0.04)	0.005
Sleep quality	T0	12.20±3.96	12.72±3.63	−0.52 (−1.78 to 0.74)	0.416
	T1	6.16±2.47	9.57±3.73			−3.30 (−3.67 to −2.39)	<0.001	−3.05 (−4.05 to −2.06)	<0.001
	T2	4.69±3.01	9.66±3.53			−2.98 (−3.68 to −2.28)	<0.001	−4.59 (−5.75 to −3.43)	<0.001

T0 indicates baseline; T1, 6 weeks after enrollment; and T2, 3 months after enrollment.

Secondary Outcomes

Compared with the control group, participants in the intervention group had significantly greater improvements in self‐care self‐efficacy (T1: β, 26.05 [95% CI, 22.50−29.60], P < 0.001; T2: β, 31.78 [95% CI, 28.07−35.48], P < 0.001), HRQOL (T1: β, −8.72 [95% CI, −12.06 to −5.37], P < 0.001; T2: β, −9.29 [95% CI, −12.82 to −5.77], P < 0.001), depression (T1: β, −1.89 [95% CI, −2.65 to −1.13], P < 0.001; T2: β, −1.32 [95% CI, −2.17 to −0.46], P < 0.001), symptom burden (T1: β, −0.14 [95% CI, −0.22 to −0.06], P < 0.001; T2: β, −1.12 [95% CI, −0.21 to −0.04], P=0.005), and sleep quality (T1: β, −3.05 [95% CI, −4.05 to −2.06], P < 0.001; T2: β, −4.59 [95% CI, −5.75 to −3.43], P < 0.001). The time‐by‐group interaction effect on anxiety was not statistically significant at either time point. Although improvements in anxiety were observed for participants in the intervention group at both T1 and T2 compared with the controls, these changes did not reach statistical significance (Table 3). Participants in the intervention group exhibited statistically significant reductions in the number of HF‐related unscheduled outpatient department visits compared with the control group (P = 0.020) at T2. However, nonsignificant differences were observed between groups regarding HF‐related hospital readmissions, hospital days, and emergency department visits at T1 and T2 (Table 4). No deaths were reported during the study period.

Table 4.

Comparison of Health Care Service Use Between the Study Groups

Health care service use	Control (n=65)	Intervention (n=68)	U	P value
	Mean (range)	Mean (range)
Number of HF‐related hospital readmissions
T1	0.06 (0–1)	0.07 (0–1)	−0.274	0.784
T2	0.08 (0–1)	0.06 (0–1)	−0.414	0.679
Length of HF‐related hospital stays
T1	0.77 (0–27)	0.50 (0–10)	−0.243	0.808
T2	0.66 (0–21)	0.26 (0–6)	−0.476	0.634
Number of HF‐related unscheduled outpatient department visits
T1	0.08 (0–2)	0.04 (0–1)	−0.465	0.642
T2	0.08 (0–1)	0	−2.323	0.020
Number of HF‐related emergency department visits
T1	0.03 (0–1)	0	−1.452	0.147
T2	0.02 (0–1)	0	−1.023	0.306

HF indicates heart failure.

DISCUSSION

The results indicated that our program significantly improved illness perceptions, self‐care behaviors, self‐care self‐efficacy, depression, symptom burden, and sleep quality, and reduced the number of HF‐related unscheduled outpatient department visits. These findings support the integration of nurse‐led self‐care services into HF management.

The improvement in illness perceptions can be attributed to the intervention’s emphasis on all the components of illness perceptions. For example, after identifying each participant’s misconceptions about the perceived causes of HF, we provided accurate information in casual elements of their conditions and clarified the relationships between these factors and HF using prepared illustrations. A lack of clear understanding of the diagnosis and symptoms has been identified as a significant issue among people with HF. ²⁹ In this program, participants learned to recognize and interpret their symptoms and signs, which helped them to establish accurate beliefs about their illness and enhance their ability to connect their symptoms with the pathophysiology of HF. Additionally, we provided patients with information on the chronic nature and recurring patterns of HF, as well as its physical and psychosocial impacts, aiming to modify their inaccurate beliefs about its negative effects on daily life and to enhance their awareness of potential negative consequences. Importantly, we provided participants with practical self‐care guidance tailored to their acute needs and supported them in setting SMART goals, developing action plans, using 4‐step problem‐solving skills to make informed decisions about their care, and addressing barriers to their self‐care process during their transition from hospital to home. These approaches instilled confidence in participants that they could effectively manage their condition through personal actions. ²⁰ The introduction of detailed treatment regimens, including surgeries, medications, and self‐care activities, along with their relationship to disease control and recurrence prevention, reinforced participants’ beliefs about the benefits of these therapies. Furthermore, the provision of disease information and emotional regulation methods alleviated participants’ negative emotional responses to their condition. Collectively, all these adopted strategies contributed to a sense of illness coherence.

This study identified statistically and clinically significant effects of our program on self‐care maintenance, symptom perception, and self‐care management. In our program, participants developed accurate perceptions of HF and acquired tailored knowledge and skills in sustaining stable physiological health, such as sodium restriction, medication management, exercise, and infectious prevention. This was complemented by strategies including goal‐setting, action‐planning, problem‐solving, decision‐making, positive feedback, and ongoing support to reinforce adherence. Despite the significant improvements, participants did not achieve adequate levels of self‐care maintenance. The reasons for this deficiency are set out below with reference to the problems identified during the intervention delivery and the analysis of items of self‐care maintenance. First, most participants reported that they rarely ate out, visited others, or had meals when visiting others during the study period. Second, nearly all the participants indicated they did not require specific reminders, such as medication storage boxes, because they could remember to take their medications, often with the assistance of caregivers. Third, participants showed a low willingness to receive vaccinations against influenza. Lastly, specific self‐care recommendations were provided on a case‐by‐case basis, with some participants not receiving strict instructions to limit sodium intake. With regard to symptom perception, our program provided participants with information on symptom observation, symptom detection, and medication side effects (eg, traffic light self‐monitoring tool), which enabled them to recognize, interpret, and label their symptoms. Participants were encouraged to adhere to the recommendations by setting individual goals and developing action plans. We also helped participants to reduce barriers that could hinder effective symptom monitoring and recognition. Despite these significant improvements, only 11.6% (8/69) of participants at T1 and 23.2% (16/69) at T2 reached sufficient symptom perception. Possible interpretations can be made. For one thing, our study allowed the frequency of monitoring symptoms, such as weight and edema assessments, to be dynamically adjusted according to participants’ circumstances and needs. Another thing is that participants were not required to document their symptoms during the study. Hence, the overall scores for symptom perception failed to reach the desired sufficiency level. Concerning self‐care management, participants in the intervention group perceived a clearer understanding of their condition and demonstrated the ability to respond effectively to the changes in their illness. They received specific suggestions and strategies for managing the onset or exacerbation of HF‐related symptoms. Furthermore, we guided them in applying 4‐step problem‐solving skills to determine appropriate strategies for managing their conditions. A majority (81.2%; 56/69) of participants achieved an adequate level of self‐care management at T1, and this figure increased to 95.7% (66/69) at T2. The analysis of self‐care management items indicated that this significant change was due to the adoption of problem‐solving skills and recommended strategies, such as further limiting sodium and fluid intake, seeking assistance from health care professionals and family members, identifying the causes of symptoms, and adjusting physical activity levels.

Comprehensive HF self‐care information and behavior change techniques have been found to significantly boost patients’ confidence in performing self‐care. ²⁰ , ⁴¹ , ⁴² , ⁶⁴ The improvement in HRQOL is not unexpected. Participants’ accurate beliefs about HF and enhanced self‐care abilities contributed to maintaining stable health and alleviating psychological distress, thereby reducing the negative impact of HF on their daily lives. ³⁰ , ⁶⁵ Investigators have shown that illness perceptions are independent factors contributing to depression among individuals with HF. ⁶⁶ This program provided participants with information to regulate negative beliefs about their condition and provided practical strategies to enhance their sense of control, ultimately mitigating depressive symptoms. We did not identify a significant intervention effect on anxiety. One possible explanation is that the presence of anxiety was contextually relevant, as participants were recruited during hospitalization, which may have led to elevated anxiety. ⁶⁴ This is further illustrated by the sharp decline in anxiety levels in both study groups after discharge. The beneficial effect on symptom burden may result from the enhanced understanding and controllability over HF. ²³ Participants received detailed information on the symptoms and signs that helped them identify and interpret the changes in their conditions. We also instructed participants to adhere to self‐care activities such as regularly taking medication, exercising, regulating negative emotions, preventing infections, and self‐monitoring their symptoms. Individuals who perceived less control over their condition and experienced a greater emotional impact faced more sleep problems. ⁶⁷ In our program, participants received information about common sleep disturbances and their influencing factors to enhance their understanding of this issue. We also provided appropriate strategies to address current and potential sleep‐related issues, such as stimulus control, relaxation exercises, sleep hygiene, and adjustments in diuretic use. Participants were instructed to use problem‐solving skills to tackle sleep‐related challenges effectively and were required to adhere to healthy sleep habits. Regarding the outcomes of health care service use and mortality, we observed a significant reduction only in the number of HF‐related unscheduled outpatient department visits. Greater engagement in self‐care is linked to decreased use of health care services. ¹² Participants received coaching to maintain health behaviors, monitor symptoms, and cope with potential risks, which reduced the need for outpatient visits. The ineffectiveness of other indicators may be attributed to the short evaluation timeframe of our study.

Study Strengths and Limitations

The present study has several strengths. First, it effectively closed the know‐do gap by addressing the barriers that limit the uptake of self‐care among people with HF. Second, the development of the intervention was guided by the CSM of Self‐Regulation and evidence‐based practices, with content tailored to the specific needs of the patients. Third, both cognitive and emotional perceptions were addressed using proper strategies. Fourth, the identified strategies used to address the variables posited in the CSM of Self‐Regulation were described clearly in this program, which facilitated the interpretation of the intervention effects and enhanced the possibility of replicating the research project for other settings and populations. Fifth, the study evaluated outcomes including symptom burden, sleep quality, depression, anxiety, health care service use, and mortality that had not been assessed in previous interventions grounded in the CSM of Self‐Regulation among patients with HF. Sixth, our findings added robust evidence supporting the benefits of nurse‐led HF self‐care interventions on illness perceptions, self‐care behaviors (self‐care maintenance, symptom perception, and self‐care management), self‐care self‐efficacy, HRQOL, symptom burden, sleep quality, and health care service use. Lastly, the study employed a methodologically rigorous research design.

This study has several limitations. The representativeness of our sample and the generalizability of the findings may have been affected by using convenience sampling. Most participants were newly diagnosed with HF or had a relatively short duration of the condition. The nature of behavioral research raises the possibility of social desirability bias when reporting outcomes, which could lead to an overestimation of the intervention effects. The study did not assess the long‐term effects of the intervention. In addition, the contributions of caregivers to patient self‐care were not evaluated.

IMPLICATIONS FOR CLINICAL PRACTICE AND RESEARCH

To begin with, we recommend that clinical nurses provide patients with tailored information on HF self‐care. This should be facilitated by a careful assessment of individual patient needs during discharge education and follow‐up counseling. Next, clinical nurses can leverage validated supporting materials to facilitate the delivery of HF self‐care information and improve patient adherence to self‐care activities. In addition to personalized self‐care information, appropriate behavior change techniques should be considered. A combined mode of delivery approach, including both individual face‐to‐face education and telephone follow‐up calls, may effectively improve self‐care services. Furthermore, it is essential that clinical nurses receive training to build and maintain competency in implementing the intervention and adhering to the established protocol. Last, this study underscores the pivotal role of nurses in disease management.

We also propose several implications for future research. First, future research ought to be conducted in different settings (eg, North, West, and East China, communities, and outpatient departments of hospitals) to recruit more representative samples. Second, future studies may consider using objective measures to quantify the actual performance of specific self‐care behaviors. Third, this study addressed knowledge gaps in applying the CSM of Self‐Regulation for patients with HF and provides a valuable guide for adopting this theoretical model in behavioral research for other chronic diseases. Lastly, our study contributes empirical evidence on the effects of nurse‐led interventions.

CONCLUSIONS

The nurse‐led CSM of Self‐Regulation‐based HF self‐care program was effective in improving illness perceptions, self‐care behaviors, self‐care self‐efficacy, HRQOL, depression, symptom burden, and sleep quality, and reducing the number of HF‐related outpatient department visits. This care model can be integrated into HF management to better support patients in vulnerable phases of HF.

Sources of Funding

None.

Disclosures

None.

Supporting information

Tables S1–S2