ABSTRACT
Background and Aims
This study aimed to evaluate the impact of the Transitional Care Model (TCM) on quality of life (QoL) and caregiver burden among family caregivers of patients with multiple chronic conditions (MCCs).
Methods
A two‐arm, single‐blind (data analysts blinded) randomized clinical trial was conducted from April to November 2024. Sixty‐eight family caregivers of hospitalized patients with MCCs were enrolled via sequential sampling and randomized into two groups using block randomization (block size = 4). The intervention group (n = 34) received routine care plus TCM from hospitalization through 2 months postdischarge, while the control group (n = 34) received routine care only. Data were collected using sociodemographic and clinical questionnaires, a validated QoL scale, and a caregiver burden scale. Analyses were performed with SPSS version 24 using descriptive and inferential statistics.
Results
Postintervention, the intervention group showed a significant increase in overall QoL scores (59.27 ± 17.66 to 63.30 ± 19.34; p = 0.02), with significant improvements in the physical, social, and environmental domains (p ≤ 0.01). No significant change was observed in the mental health domain (p = 0.06). Caregiver burden scores decreased significantly (52.48 ± 15.86 to 49.09 ± 15.89; p < 0.001). In the control group, overall QoL, physical health, and mental health scores decreased significantly (p ≤ 0.02), while caregiver burden increased significantly (59.31 ± 14.30 to 61.34 ± 14.03; p < 0.001). Between‐group comparisons post‐intervention revealed higher overall QoL and physical, mental, and environmental health scores (p ≤ 0.01) and lower caregiver burden (p = 0.004) in the intervention group; social relations did not differ (p = 0.51).
Conclusion
The TCM appears to be a promising approach for reducing caregiver burden and improving quality of life among family caregivers of patients with MCCs. However, given the relatively small sample size, further large‐scale studies are warranted to confirm and extend these findings.
Keywords: caregiver burden, caregivers, chronic disease, multiple chronic conditions, quality of life, transitional care
1. Introduction
1.1. Multiple Chronic Conditions Overview
Multiple chronic conditions (MCCs) are defined as the coexistence of two or more chronic diseases [1]. In 2023, 51.4% of US adults (approximately 130 million individuals) reported having MCCs, with prevalence rates of 27.1%, 52.7%, and 78.8% among young, midlife, and older adults, respectively. Among young adults, the prevalence of MCCs increased significantly from 21.8% in 2013 to 27.1% in 2023 [2].
The most common MCCs include diabetes, cardiovascular disease, hypertension, chronic obstructive pulmonary disease, chronic kidney disease, cancer, arthritis, and depression [3].
1.2. Focus on Diabetes Among MCCs
Diabetes is highly prevalent among individuals with MCCs [4]. Diabetes mellitus is a complex and challenging chronic condition characterized by elevated blood glucose levels due to impaired β‐cell function and insulin action. If not appropriately managed, particularly in the presence of additional comorbidities, it may lead to serious complications and adverse health outcomes [5]. The global prevalence of diabetes among adults aged 20–79 years was estimated at 10.5% (536.6 million people) in 2021 and is projected to rise to 12.2% (783.2 million people) by 2045 [6]. In Iran, baseline data from a cohort study reported a diabetes prevalence of 9.9% [7]. Beyond its prevalence, type 2 diabetes often serves as a central condition in multimorbidity patterns due to its progressive nature, need for continuous self‐management, and risk of systemic complications. These characteristics make it a particularly relevant condition when examining the impact of MCCs on family caregiving [8].
The two predominant forms of diabetes are type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM), both diagnosed using established clinical criteria [5]. T1DM results from autoimmune β‐cell destruction and typically manifests in childhood, whereas T2DM is characterized by insulin resistance and relative insulin deficiency. T2DM is strongly associated with genetic predispositions and lifestyle factors, such as obesity and physical inactivity [9], and accounts for over 96% of all diabetes cases [10].
1.3. Diabetes and Cardiovascular Comorbidities
Most adults with T2DM have at least one additional chronic condition [11]. Individuals with T2DM are at approximately 2.3 times higher risk of cardiovascular disease than those without diabetes [5], with heart failure (HF) being one of the most frequent cardiovascular manifestations [10]. The coexistence of HF and diabetes affects nearly 40% of patients [12].
The exact pathophysiological mechanisms linking diabetes and HF remain unclear, but hyperglycemia, insulin resistance, and hyperinsulinemia appear to initiate and perpetuate disease progression [13]. Patients with comorbid HF and diabetes exhibit distinct metabolic, neurohormonal, and structural cardiac abnormalities, leading to a worse prognosis than either condition alone [14]. Consequently, these patients face a high risk of health status deterioration, hospitalization, or death [15].
1.4. Health‐Related Decline and Caregiving
The health‐related decline in patients with MCCs often necessitates increased caregiving from family members or friends [16]. However, informal caregivers are frequently unprepared for long‐term caregiving responsibilities, which can adversely affect family functioning and health [17, 18].
Caring for patients with MCCs is associated with increased caregiver burden [19, 20] and diminished quality of life (QoL) among caregivers [19, 21].
1.5. Caregiver Burden and QoL
Caregiver burden refers to the caregivers multifaceted strain experienced by caregiver in ‘roviding care' for their family members or loved ones over time [22], and includes the physical, financial, and psychosocial hardships of caring for individual struggling with medical conditions For example, Dings study reported that 71.8% of caregivers of patients with MCC perceived a significant level of burden.
Caregiver burden refers to the multifaceted strain experienced by caregivers in providing care to family members or loved ones over time [22]. It encompasses physical, financial, and psychosocial hardships associated with caring for individuals with medical conditions [23]. For instance, one study reported that 71.8% of caregivers of patients with MCCs perceived a significant burden [24].
Caregiver burden is also a major predictor of QoL [25]. The World Health Organization defines QoL as “an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns” [26]. Prior studies indicate that family caregivers are at risk of poor QoL due to their caregiving experiences [27, 28].
The consequences of caregiver burden are profound, including reduced care delivery, physical and psychological deterioration, and diminished QoL for both caregivers and care recipient [22]. Therefore, assessing caregiver burden and QoL is essential to develop targeted interventions and support mechanisms.
1.6. Transitional Care and the Transitional Care Model (TCM)
Previous studies suggest that structured discharge planning effectively prepares family caregivers for their responsibilities [18, 29]. However, despite efforts to ensure safe transitions from hospital to home, family caregivers often struggle to fulfill their duties during this phase due to limited knowledge of disease management [30, 31].
Transitional care programs aim to reduce post‐discharge complications and readmission rates by ensuring continuity of care during transfers between healthcare settings. The TCM comprises 10 interconnected components, emphasizing continuity of care (consistent, coordinated, and seamless delivery of medical and support services across providers and settings), collaboration with patients, families, and healthcare professionals, patient and family education, and nurse‐led coordination.
Naylor et al. describe this type of transitional care as a coordinated set of activities designed to ensure continuity and coordination of healthcare as patients move between care settings, further emphasizing the importance of a structured approach during these vulnerable periods [32]. Although developed countries prioritize transitional care during discharge [18], evidence indicates a lack of suitable guidelines in Iran [33].
A qualitative study in Iran exploring family caregivers' experiences of transitional care for patients with diabetes and MCCs revealed unsafe transitions (e.g., unplanned discharge, poor communication, lack of patient‐centered care, and unavailable healthcare teams), leading to erosive efforts (e.g., financial burden, psychological stress, physical exhaustion, and lack of support resources) [18]. In contrast, implementing TCM has been shown to improve QoL, enhance disease knowledge, and reduce readmissions [34, 35].
1.7. Research Gap and Study Objective
The findings of prior studies and caregivers' experiences highlight a significant gap in research conducted in iran regarding TCM interventions focused on family caregivers of patients with MCCs. Most existing studies have prioritized patients, with less attention to caregivers' needs, burden, and QoL. Therefore, designing and implementing a caregiver‐focused transitional care program for patients with MCCs is essential. Accordingly, this study investigated the effects of a TCM‐based intervention on caregiver burden and QoL among family caregivers of hospitalized patients with MCCs at selected hospitals affiliated with Isfahan University of Medical Sciences in 2024.
2. Methods
2.1. Study Design and Settings
This two‐arm, single‐blind (data analysts blinded) randomized clinical trial was conducted from April to November 2024 at two hospitals affiliated with Isfahan University of Medical Sciences, Iran. Isfahan, one of Iran's largest cities, is characterized by a diverse population and rich traditional culture. In this cultural context, strong familial bonds play a pivotal role in patient support, encompassing clinical assistance, comprehensive caregiving, and emotional support during hospitalization and post‐discharge [18]. The study was conducted at Shahid Chamran and Khorshid Hospitals, two specialized cardiovascular centers in Isfahan where patients with HF are predominantly admitted. Cardiac units were selected because the target population consisted of patients with coexisting type 2 diabetes and HF, and these departments facilitated the identification and recruitment of eligible participants with both conditions.
2.2. Study Participants
Family caregivers of patients with MCCs who met the inclusion criteria were identified and approached by the research team in hospital wards. After obtaining institutional approvals and completing necessary coordination, the researcher visited Shahid Chamran and Khorshid Hospitals on consecutive weekdays (Saturday to Thursday) from 8:00 am to 13:00 pm. Using convenience sampling, patients admitted within the previous 48 h were screened based on the study inclusion criteria. The study objectives were explained, and written informed consent was obtained from eligible caregivers. The World Health Organization Disability Assessment Schedule, 12‐item version (WHODAS‐12), was then administered to caregivers to assess patient functional dependency. Caregivers of patients scoring > 24 (indicating severe disability) were enrolled. After 35 visits, 68 caregivers meeting the inclusion criteria were recruited and equally allocated to the intervention (n = 34) and control (n = 34) groups using block randomization (block size = 4).
Participants were allocated to the intervention (A) or control (B) group using block randomization (block size = 4). Randomization sequences (AABB, ABAB, ABBA, BBAA, BABA, and BAAB) were prepared and randomly ordered. Eligible caregivers selected and opened sealed envelopes containing group assignments at enrollment, with the process repeated until the target sample size was achieved. Three participants from the intervention group withdrew due to unwillingness to continue and were excluded from analysis (Figure 1).
Figure 1.
Consort flow diagram.
The inclusion criteria for the family caregiver included; willing to participate in the study, being over 18 years of age, being able to speak Persian language, having the ability to provide patient care and administer prescribed medications, having no psychological problems based on self‐report, and being the person responsible for the care of a patient with both diabetes and HF, requiring home care due to disability that was determined based on the WHODAS‐12 (If a patient scored higher than 24, their caregiver was enrolled in the study). This tool was therefore used exclusively for screening purposes at baseline to ensure that only caregivers of patients with functional dependency were included in the study. Participants were excluded if the patient was unwilling to continue the intervention, was discharged or died during the study, or was concurrently enrolled in a similar study.
2.3. Sample Size
The sample size was calculated using G*Power software (version 3.1.9.7) based on an effect size of 0.7 from a prior study [36], a 95% confidence level, and 80% statistical power. This yielded a minimum of 28 participants per group. Accounting for an anticipated 30% attrition rate, the final sample size was set at 34 participants per group (total n = 68).
2.4. Intervention
The intervention was based on the TCM developed by Mary Naylor, which comprises 10 key components [32]. (see Table 1). Transitional care was initiated at hospital admission and continued for approximately 2 months after discharge through hospital and home visits, telephone follow‐ups, and virtual support.
Table 1.
Comparison of demographic characteristics between the two group.
| Variable | Intervention group (N = 31) | Control group (N = 34) | p value | |
|---|---|---|---|---|
| Age (mean (SD)) | 47.68 (12.58) (95% CI: 43.06–52.30) | 53.91 (13.85) (95% CI: 49.10–58.72) | 0.6 | |
| Number of children (mean (SD)) | 2.55 (2.06) (95% CI: 1.79–3.31) | 2.94 (1.59) (95% CI: 2.39–3.49) | 0.39 | |
| Number of hours of care per day (mean (SD)) | 17.81 (6.69) (95% CI: 15.36–20.26) | 18.85 (7.15) (95% CI: 16.35–21.35) | 0.54 | |
| Number of days of care per week (mean (SD)) | 5.87 (1.59) (95% CI: 5.28–6.46) | 5.79 (1.68) (95% CI: 5.21–6.37) | 0.85 | |
| Gender (n %) | Female | 28/31 (90.3%) | 24/34 (70.6%) | 0.06 |
| Male | 3/31 (9.7%) | 10/34 (29.4%) | ||
| Marital status (n %) | Married | 27/31 (87.1%) | 31/34 (91.2%) | 0.70 |
| Single | 4/31 (12.9%) | 3/34 (8.8%) | ||
| Relative to the patient (n %) | Son | 3/31 (9.7%) | 5/34 (14.7%) | 0.25 |
| Daughter | 9/31 (29.0%) | 4/34 (11.8%) | ||
| Wife | 14/31 (45.2%) | 19/34 (55.9%) | ||
| Brother | 0/31 (0%) | 1/34 (2.9%) | ||
| Sister | 3/31 (9.7%) | 1/34 (11.8%) | ||
| Other | 2/31 (6.5%) | 0/34 (0%) | ||
| Job (n %) | Self‐employed | 2/31 (6.5%) | 4/34 (11.8%) | 0.35 |
| Office worker | 1/31 (3.2%) | 4/34 (11.8%) | ||
| Student | 0/31 (0%) | 0/34 (0%) | ||
| Unemployed | 0/31 (0%) | 0/34 (0%) | ||
| Housekeeper | 27.31 (87.1%) | 23/34 (67.6%) | ||
| Retired | 1/31 (3.2%) | 3/34 (8.8%) | ||
| Education (n %) | Under diploma | 14/31 (45.2%) | 24/34 (75.0%) | 0.13 |
| Diploma | 13/31 (41.9%) | 6/34 (17.6%) | ||
| Bachelor's degree | 2/31 (6.5%) | 2/34 (5.9%) | ||
| Master's degree and above | 2/31 (6.5%) | 2/34 (5.9%) | ||
| History of illness (n %) | Yes | 18/31 (58.1%) | 21/34 (61.8%) | 0.80 |
| No | 13/31 (41.9%) | 13/34 (38.2%) | ||
Abbreviations: CI, confidence intervals; n, number; SD, standard deviation.
Within 24 h of hospital admission, the researcher met with each patient and their primary caregiver to conduct an educational needs assessment using validated questionnaires. Based on these findings, a personalized face‐to‐face educational session was held, covering topics such as disease characteristics and prognosis, treatment and recovery process, medication and dietary management, rest and activity recommendations, potential complications, danger signs, and appropriate times to seek medical attention. Caregivers were also provided with comprehensive educational booklets on diabetes and HF summarizing the content of these sessions. To further clarify ambiguities and answer questions, a virtual group discussion was organized through the Eitaa platform.
During hospitalization, daily visits were conducted for the first 4 days. Within 24 h of discharge, a comprehensive follow‐up visit was carried out to monitor the patient's condition. This assessment included complete recording of vital signs, blood glucose, weight, respiratory function, and organ status; evaluation of assistive device use, rest/activity balance, mood, diet, medication adherence, and compliance with care instructions. Patients were re‐educated about recognizing danger signs that require immediate transfer to the nearest emergency department without prior contact with the researcher. Caregivers were instructed that they could contact the researcher at any time if concerns or problems arose. Collaborative consultations with patients and their caregivers were used to make post‐discharge care decisions aligned with their individual preferences and goals.
A comprehensive assessment was conducted during hospitalization, evaluating patients' and caregivers' goals, illness characteristics (nature, duration, and severity), comorbid conditions, physical, cognitive, and emotional health, health behaviors and self‐care skills, and the adequacy of social support systems. Education was continuously provided regarding patient care, identification of danger signs, and appropriate responses. The care plan emphasized patient and caregiver engagement through clearly stated treatment and care goals and collaborative participation.
To ensure continuity of care, patients and caregivers were informed about physician appointment schedules and procedures for arranging follow‐up visits. When rehabilitation services were required, the program details were explained, and coordination for continued care was established. A trusting, therapeutic relationship was maintained between the researcher, patients, and caregivers throughout the intervention.
Following discharge, weekly telephone follow‐ups (at least one per week) were conducted for 2 months. These calls assessed vital signs, blood glucose, weight, limb swelling, pressure ulcers, leg sensitivity, shortness of breath, diet, urinary and fecal elimination, appetite, medication adherence and interactions, sleep/rest patterns, and depressive symptoms. Additional education and counseling were provided as needed. A standardized screening tool was applied to identify patients at risk, and identified needs were communicated to the nurse responsible for patient care. A personalized discharge plan was jointly developed with each patient and their caregiver and implemented collaboratively. Ongoing reassessment of clinical risks and care needs continued throughout the follow‐up period.
2.5. Data Collection and Analysis
-
1.
Demographic checklist
A structured checklist was used to collect caregivers' sociodemographic and caregiving‐related information, including gender, age, medical history, marital status, education level, number of children, hours and days of caregiving per week, and relationship to the patient.
-
2.
Zarit Burden Interview (ZBI)
The ZBI, developed by Zarit et al., is a 22‐item instrument assessing caregiver burden across physical, psychological, financial, and social domains. Items are rated on a 5‐point Likert scale (0 = never to 4 = always), yielding a total score ranging from 0 to 88. Burden levels are categorized as: no to little (0–20), mild to moderate [21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40], moderate to severe [41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60], and severe (61–88). Content validity was established in Iran by Pahlavanzadeh et al. with test‐retest reliability of 0.94 [37]. In this study, internal consistency was confirmed with Cronbach's α = 0.93.
-
3.
World Health Organization Quality of Life‐BREF (WHOQOL‐BREF)
The WHOQOL‐BREF, developed by the World Health Organization (1996), is a 26‐item instrument measuring QoL across four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items), plus two general items. Responses are scored on a 5‐point Likert scale. Raw domain scores are transformed to a 0–100 scale, with higher scores indicating better QoL. In Iran, Nedjat et al. reported Cronbach's α values of 0.70 (physical), 0.73 (psychological), 0.55 (social), and 0.84 (environmental), with test‐retest reliability of 0.70 [38]. In this study, overall internal consistency was confirmed with Cronbach's α = 0.94.
2.6. Data Analysis
Data were analyzed using IBM SPSS Statistics version 26 (IBM Corp., Armonk, NY, USA). Normality of continuous variables was assessed using the Kolmogorov–Smirnov test, with all distributions confirmed as normal (p > 0.05). Continuous variables (age, number of children, hours of care per day, days of care per week) are reported as means, standard deviations (SD) and 95% confidence intervals (CI). Categorical variables (gender, marital status, relationship to patient, employment status, education level, medical history) are presented as frequencies and percentages (n, %).
Between‐group comparisons of normally distributed continuous outcomes (QoL and caregiver burden) were performed using independent‐samples t‐tests (two‐sided). Within‐group pre‐post changes in QoL and caregiver burden were evaluated using paired‐samples t‐tests (two‐sided). Categorical variables were compared between groups using chi‐square tests or Fisher's exact tests, as appropriate. Between‐group comparisons of continuous sociodemographic variables (age, number of children, hours of care per day, days of care per week) were conducted using independent‐samples t‐tests. All statistical tests were two‐sided with a significance level of p < 0.05.
To strengthen internal validity and reduce potential bias, block randomization with sealed envelope allocation was used, data analysts were blinded to group assignment, validated outcome measures were applied, and baseline comparability between groups was confirmed.
3. Result
A total of 68 family caregivers of patients with diabetes and HF participated in the study, with 34 in the intervention group and 34 in the control group. During the study, three participants (8.82%) (3/34) in the intervention group withdrew, leading to incomplete post‐test and follow‐up data. The final analysis included 31 participants in the intervention group and 34 in the control group.
The mean (±SD) age of participants was 47.68 ± 12.58 years in the intervention group and 53.91 ± 13.85 years in the control group. In the intervention group, 9.7% (3/31) were male and 90.3% (28/31) were female, whereas in the control group, 29.4% (10/34) were male and 70.6% (24/34) were female. Other baseline demographic characteristics are presented in Table 1. There were no statistically significant baseline differences between the two groups with respect to age (p = 0.60), gender (p = 0.06), marital status (p = 0.70), education level (p = 0.13), relationship to the patient (p = 0.25), job status (p = 0.35), history of illness (p = 0.80), number of children (p = 0.39), hours of care per day (p = 0.54), or days of care per week (p = 0.85) (Table 1).
3.1. Within‐Group Comparisons
Paired‐sample t‐tests were used to compare pre‐ and post‐intervention scores within each group (Table 2).
Table 2.
Comparison of patients' outcome before and after the intervention between the two groups.
| Outcomes | Time | Intervention [31] | Control [34] | p value** | Cohen's d (95% CI) |
|---|---|---|---|---|---|
| Overall quality of life and general health | Before intervention | 59.27 (17.66) (95% CI: 52.78–65.76) | 56.16 (14.18) (95% CI: 51.22–61.10) | 0.50 | |
| After intervention | 63.30 (19.34) (95% CI: 56.20–70.40) | 53.90 (13.99) (95% CI: 49.02–58.78) | 0.010 | 0.55 (0.06–1.05) | |
| p‐value* | 0.020 | 0.020 | |||
| QOL. physical health | Before intervention | 61.17 (14.51) (95% CI: 55.84–66.50) | 59.78 (14.90) (95% CI: 54.59–64.97) | 0.70 | |
| After intervention | 63.82 (13.48) (95% CI: 58.87–68.77) | 54.79 (13.22) (95% CI: 50.18–59.40) | 0.009 | 0.68 (0.18–1.19) | |
| p‐value* | 0.010 | p < 0.001 | |||
| QOL. mental health | Before intervention | 55.64 (16.85) (95% CI: 49.45–61.83) | 53.68 (13.34) (95% CI: 49.03–58.33) | 0.59 | |
| After intervention | 57.79 (14.85) (95% CI: 52.34–63.24) | 49.21 (10.81) (95% CI: 45.44–52.98) | 0.010 | 0.68 (0.18– 1.18) | |
| p‐value* | 0.060 | p < 0.001 | |||
| QOL. social relations | Before intervention | 54.56 (22.34) (95% CI: 46.35–62.77) | 57.84 (16.53) (95% CI: 52.08–63.60) | 0.50 | |
| After intervention | 59.40 (22.33) (95% CI: 51.20–67.60) | 65.25 (15.69) (95% CI: 59.78–70.72) | 0.51 | −0.30 (−0.78 to 0.19) | |
| p‐value* | p < 0.001 | 0.70 | |||
| QOL. environmental health | Before intervention | 54.43 (15.88) (95% CI: 48.60–60.26) | 53.21 (9.15) (95% CI: 50.02–56.40) | 0.70 | |
| After intervention | 58.77 (15.01) (95% CI: 53.26–64.28) | 51.36 (8.39) (95% CI: 48.44–54.28) | 0.010 | 0.64 (0.14–1.14) | |
| p‐value* | p < 0.001 | 0.25 | |||
| Caregiving burden | Before intervention | 52.48 (15.86) (95% CI: 46.65–58.31) | 59.31 (14.30) (95% CI: 54.33–64.29) | 0.07 | |
| After intervention | 49.09 (15.89) (95% CI: 43.25–54.93) | 61.34 (14.03) (95% CI: 56.45–66.23) | 0.004 | −0.87 (−1.37 to −0.37) | |
| p‐value* | p < 0.001 | p < 0.001 |
Abbreviations: CI, confidence interval; QOL, quality of life.
Calculated using paired sample t‐test
Calculated using independent t‐test p < 0.05
In the intervention group, the mean overall QoL and general health score significantly increased from 59.27 ± 17.66 at baseline to 63.30 ± 19.34 postintervention (p = 0.02). Improvements were observed in physical health (61.17 ± 14.51 to 63.82 ± 13.48; p = 0.01), social relationships (54.56 ± 22.34 to 59.40 ± 22.33; p < 0.001), and environmental health (54.43 ± 15.88 to 58.77 ± 15.01; p < 0.001). The increase in mental health scores (55.64 ± 16.85 to 57.79 ± 14.85) was not statistically significant (p = 0.06). The mean caregiving burden score declined significantly from 52.48 ± 15.86 to 49.09 ± 15.89 (p < 0.001).
In the control group, overall QoL and general health decreased significantly from 56.16 ± 14.18 to 53.90 ± 13.99 (p = 0.02). Physical health (59.78 ± 14.90 to 54.79 ± 13.22; p < 0.001) and mental health (53.68 ± 13.34 to 49.21 ± 10.81; p < 0.001) also declined significantly. No statistically significant changes were observed in social relationships (57.84 ± 16.53 to 65.25 ± 15.69; p = 0.70) or environmental health (53.21 ± 9.15 to 51.36 ± 8.39; p = 0.25). Caregiving burden significantly increased from 59.31 ± 14.30 to 61.34 ± 14.03 (p < 0.001) (Table 2).
3.2. Between‐Group Comparisons
Independent‐sample t‐tests were used to assess differences between groups before and after the intervention (Table 2).
At baseline, there were no statistically significant differences between the intervention and control groups in overall QoL and general health (p = 0.50), physical health (p = 0.70), mental health (p = 0.59), social relationships (p = 0.50), environmental health (p = 0.70), or caregiving burden (p = 0.08).
After the intervention, the intervention group had significantly higher mean scores in overall QoL and general health (p = 0.01), physical health (p = 0.009), mental health (p = 0.01), and environmental health (p = 0.01) compared with the control group. The mean caregiving burden score was significantly lower in the intervention group (p = 0.004). No significant difference was found between groups regarding social relationships (p = 0.51) (Table 2).
4. Discussion
This study aimed to evaluate the effect of implementing the TCM on the QoL and caregiving burden among family caregivers of patients with MCCs. The implementation of the TCM led to significant improvements in three domains of QoL—physical health, environmental health, and social relationships (p < 0.001). However, no significant improvement was observed in the mental health domain within the intervention group. Additionally, the social relationship subscale showed no statistically significant difference between groups (p = 0.51). The intervention also significantly reduced caregiver burden compared with the control group. To the authors' knowledge, this study represents the first clinical trial in Iran to concurrently assess the impact of a structured transitional care program on both QoL and caregiving burden among family caregivers of patients with coexisting diabetes and HF. The findings highlight that while transitional care interventions effectively enhance certain aspects of caregivers' well‐being, integrating targeted psychological support modules and long‐term social engagement strategies is crucial to achieving sustained improvements in mental health and social functioning.
QoL among caregivers of patients with MCCs is shaped not only by caregiving responsibilities but also by the clinical complexity and symptom burden associated with specific disease combinations. T2DM and HF frequently coexist and have a bidirectional pathophysiologic relationship, whereby diabetes increases the risk of developing HF and the presence of HF worsens metabolic control and symptom severity in diabetes patients [39]. Patients with both conditions experience greater severity of dyspnea and other cardiorespiratory symptoms compared to HF alone, indicating higher symptom burden and physiological stress that compromise daily functioning and well‐being [40]. In addition, unpredictable symptoms such as exercise intolerance, fatigue, and glycemic fluctuations further exacerbate caregiving demands. These overlapping clinical manifestations not only diminish patients' functional status but also impose substantial physical, emotional, and social strain on caregivers [41]. Within this clinical and psychosocial context, the TCM provides a structured framework for education, symptom monitoring, and care coordination, which may explain its beneficial impact on several QoL domains and caregiver burden observed in this study.
4.1. Impact on QoL
The TCM intervention significantly improved overall QoL and three domains—physical health, psychological health, and environmental health—among family caregivers. These findings align with prior research demonstrating that structured home‐based interventions enhance caregiver well‐being. For instance, Bužgová et al. and Gök Ugur and Erci reported improved QoL following targeted home care programs for caregivers of patients with chronic conditions [42, 43]. Similarly, Griffin et al. found that a transitional palliative care intervention significantly enhanced QoL among family caregivers of patients with advanced illness [44].
Family caregivers of patients with complex health needs, such as comorbid diabetes and HF, frequently experience diminished physical, psychological, and social functioning [45]. Without adequate support, caregiving demands exacerbate burden and stress, further compromising well‐being [46, 47, 48]. This study underscore the critical role of TCM in mitigating these adverse effects through comprehensive education, monitoring, and care coordination, thereby addressing the multifaceted needs of both patients and caregivers during care transitions.
Based on the results of this study, implementation of the TCM did not improve mental health outcomes among family caregivers of patients with diabetes and HF. This null finding aligns with a growing body of literature indicating that short‐term, education‐focused interventions are insufficient to alleviate the chronic psychological distress experienced by family caregivers [49, 50]. Several mechanisms may account for this lack of effect. First, the psychological burden of caregiving is often cumulative and resistant to brief interventions, particularly in the context of multimorbidity, where demands are unpredictable and emotionally taxing [41]. Second, the intervention lacked structured psychological components—such as cognitive‐behavioral strategies, mindfulness training, or professional counseling—that have demonstrated efficacy in prior trials targeting caregiver mental health [51, 52]. Third, baseline mental health scores were moderately low (mean ± SD, 55.6 ± 16.8), suggesting that many participants were already experiencing subclinical depression or anxiety; in such cases, low‐intensity support without screening or referral pathways to clinical services is unlikely to yield meaningful psychological improvements. Finally, cultural factors may have contributed. In collectivist societies, caregivers often normalize emotional distress as a familial duty, resulting in low help‐seeking behavior and diminished perceived need for mental health support [53]. This may have reduced the perceived value of the psychosocial elements within the TCM.
Comparative evidence supports these interpretations. A meta‐analysis found that only interventions incorporating explicit psychological modules (e.g., cognitive‐behavioral therapy, peer support, or guided self‐help) significantly improved caregiver depression and anxiety, whereas purely educational or logistical interventions did not not [54]. Similarly, a recent randomized controlled trial among caregivers of patients with HF reported no mental health improvements following a 6‐week discharge education program, but significant gains when the program was augmented with weekly tele‐counseling [55]. Accordingly, future transitional care protocols should routinely incorporate pre‐discharge interventions (e.g., counseling sessions, relaxation exercises, and stress‐coping skills) or post‐discharge interventions (e.g., digital platforms such as telephone follow‐up and educational videos).
This study found no significant between‐group differences in the mean score of social relations (a domain of QoL) following the intervention. These findings align with prior research. For instance, a Brazilian study reported that, although most caregivers were satisfied with their social relations, caregiving burden and duration were the primary factors associated with lower mean scores in this domain; notably, receipt of formal or informal social support did not significantly improve social relations [56]. Similarly, another study found that, despite supportive interventions, social relations scores among caregivers exceeded those of other quality‐of‐life domains but showed no significant differences compared with control groups [57].
Several factors may explain this null effect. First, social relations are complex and multidimensional, shaped by cultural, familial, and individual beliefs; thus, short‐term educational or supportive interventions may be insufficient to induce meaningful change. Second, caregivers often lack the time to develop or maintain new social connections due to heavy responsibilities and time constraints, a barrier consistently documented in the literature [56, 57]. The unchanged social relations score aligns with prior reports that brief, education‐oriented programs rarely expand caregivers' social networks. Daily caregiving demands leave little discretionary time, and social embeddedness is shaped by longstanding cultural norms; consequently, short‐term interventions cannot foster the repeated, real‐world social contacts required for measurable improvements. Future TCMs should therefore incorporate longer‐term, individualized strategies—such as respite vouchers to enable community activities, peer‐matching platforms sustained for ≥ 6 months post‐discharge, and family‐mediated social network mapping—to transform temporary support into enduring social engagement.
4.2. Impact on Care Burden
The TCM significantly reduced caregiver burden among family caregivers. In contrast, burden increased in the control group after 2 months. These findings align with prior research. For instance, Dağdelen and Zincir reported that a postoperative home care model enhanced patients' self‐care, alleviated symptoms, and reduced caregiver burden [58]. Similarly, Bitek and Erol found that discharge education combined with telephone follow‐up significantly lowered caregiver burden among family caregivers of stroke patients [59]. Consistent with these results, Hekmatpou et al. demonstrated that a home care program reduced caregiver burden for stroke patients' families [36].
However, these effects are not universal. Vandepitte et al. reported that, although a home care program for dementia caregivers reduced short‐term social and family pressures, it had no sustained impact on caregiver burden at 6 months [60]. These discrepancies may stem from variations in patients' physical and mental health, caregivers' characteristics, cultural and ethnic differences in intervention uptake, and intervention type.
4.3. Limitations
This study has several limitations. First, the relatively small sample size may have limited statistical power and generalizability. Second, the short follow‐up period precluded assessment of long‐term effects. Third, reliance on self‐reported data may have introduced response bias. Nonetheless, these findings indicate that the transitional care program positively impacts QoL and caregiver burden among family caregivers of patients with diabetes and HF.
5. Conclusion
This study demonstrated that the TCM significantly improved QoL and reduced caregiver burden among family caregivers of patients with coexisting diabetes and HF. However, mental health outcomes in the intervention group showed no significant improvement, whereas mental health declined in the control group, underscoring the need for targeted psychological support. The reduction in caregiver burden in the intervention group, contrasted with its increase in the control group, confirms the intervention's efficacy in alleviating burden. These findings highlight the value of structured transitional care programs in enhancing caregivers' well‐being and support their integration into standard care for patients with MCCs. Future research should prioritize psychological interventions for caregivers and evaluate their long‐term effects on both caregiver and patient outcomes.
Author Contributions
Leila Mardanian Dehkordi conceptualized the research, designed the study protocol, oversaw its implementation, conducted the and statistical analysis and contributed to the drafting of manuscript. Maryam karami collected the data and contributed to the drafting of manuscript. Additionally, Narges Hashemi critically reviewed and edited the manuscript draft, ensuring that the content was aligned with the research objectives and scholarly standards. All authors have read and approved the final version of the manuscript. Leila Mardanian Dehkordi had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis Leila mardanian dehkordi had full access to all of the data in this study and takes complete responsibility for the integrity of the data and the accuracy of the data analysis.
Ethics Statement
This study, conducted in 2024, was approved by the Ethics Committee of Isfahan University of Medical Sciences (code: IR.MUI.NUREMA.REC.1402.091) and registered in the Iranian Registry of Clinical Trials (code: IRCT20170625034743N3). All participants received a comprehensive explanation of the study's purpose, methods, and requirements, ensuring full understanding of their involvement. Written informed consent was obtained from each participant. Participant confidentiality was strictly maintained, with only aggregated data reported. All procedures adhered to relevant ethical guidelines and regulations.
Conflicts of Interest
The authors declare no conflicts of interest.
Policy on Using ChatGPT and Similar AI Tools
During preparation of this manuscript, the authors used Grok 3 to enhance readability and language. The content was subsequently reviewed and edited by a native English editor as needed. The authors take full responsibility for the published content.
1. Transparency Statement
The lead author Leila Mardanian Dehkordi affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Acknowledgments
This article is part of a research project (grant number: 3402191) at Isfahan University of Medical Sciences (MUI). We would like to express our gratitude to the study participants for their invaluable cooperation throughout the study. Their contributions were essential to the success of this research. No patient or member of public contributed to the design, implementation analysis, or data interpretation of this study. The financial sources/relationships have had no involvement in the study design; data collection, analysis, and interpretation; writing of the report; or the decision to submit the report for publication.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.