3.1. Study Design and Setting
This cross-sectional, descriptive-correlational study was conducted from April 2025 to April 2026 at Alavi Educational and Medical Center, a teaching hospital in Ardabil, Iran. The study setting included the Emergency Department, Intensive Care Unit (ICU), and Neurology Department. Participants included eligible nurses working in these units, discharged patients with stroke who had received care at the center, and their primary family caregivers.
3.2. Sample Size and Sampling
The sample size for patients and caregivers was determined using the correlation formula:
The calculation was based on a pilot correlation coefficient of r = 0.205 between family participation and self-management. The pilot study involved a small group of eligible stroke patient-caregiver dyads with characteristics similar to those of the main study population and was conducted to provide a preliminary estimate for sample size determination. To improve precision and reduce the risk of type I error in this clinically important population, a 99% confidence level and 80% statistical power were used. Based on these assumptions, the minimum required sample size was estimated at 278 participants. After allowing for 10% attrition, 306 participants were recruited.
Patients were selected from the Hospital Information System medical records using a random-number table. Because the study involved patient-caregiver dyads, each enrolled patient was paired with a primary family caregiver, yielding 306 matched patient-caregiver dyads. Nurses (n = 71) were recruited using a census approach.
3.3. Inclusion and Exclusion Criteria
Patients were eligible if they were aged 18 years or older, had a confirmed clinical diagnosis of stroke, had been discharged from Alavi Educational and Medical Center, and were available for follow-up exactly 1 month after discharge. Written informed consent was also required. Patients were excluded if they had preexisting psychiatric disorders, incomprehensible speech, or uncorrectable hearing loss.
Primary family caregivers, including spouses, children, siblings, or parents, were eligible if they were aged 18 years or older and directly involved in the patient’s care. Caregivers were excluded if they were simultaneously providing care for another patient.
Eligible nurses had at least 3 months of professional clinical experience in stroke care and provided written informed consent. Questionnaires with substantial missing data and cases in which participants withdrew from the study were excluded from the final analysis.
3.4. Data Collection and Instruments
The data collection instruments comprised 6 sections: 3 sociodemographic questionnaires designed separately for nurses (12 items), family caregivers (14 items), and patients (18 items), and 3 standardized study instruments. The nurse questionnaire included variables such as age, sex, marital status, education level, work experience, and ward of service. The caregiver questionnaire included age, sex, marital status, education level, relationship to the patient, and employment status. The patient questionnaire included age, sex, marital status, education level, type of stroke, and disease-related characteristics.
Data collection procedures differed by participant group. Nurses completed questionnaires in person at Alavi Educational and Medical Center. Data from patients with stroke and their primary family caregivers were collected through telephone interviews conducted at least 1 month after the patient’s discharge. A total of 306 patients and 306 primary family caregivers participated. Each interview lasted approximately 15 minutes and was conducted first with the primary caregiver and then with the patient.
The Stroke Care Competence Questionnaire (SCCQ) is a 41-item instrument developed by Kipinä et al. (
26) to assess nurses’ competence in stroke care. Items are rated on a 5-point Likert scale from 1 (poor) to 5 (excellent), with higher scores indicating greater competence. The SCCQ comprises 4 domains: 1) counseling and interaction (19 items), 2) evidence-based practice (8 items), 3) self-management and development (8 items), and 4) interdisciplinary collaboration (6 items). In the original study, Cronbach α coefficients ranged from 0.89 to 0.96 across the 4 domains. In the present study, the SCCQ demonstrated excellent internal consistency (Cronbach α = 0.97). The Persian version was prepared using forward-backward translation, and its face and content validity were confirmed by 10 faculty members in nursing and public health using the Waltz and Bausell method (content validity index [CVI] = 0.96, content validity ratio [CVR] = 0.88). For interpretation, the midpoint score was calculated using the formula (maximum - minimum)/2 + minimum.
The Family Collaborative Care Questionnaire is a 10-item instrument developed by Suwanno et al. (2023). It uses a 5-point Likert scale from 1 (not sure) to 5 (completely sure), with higher scores indicating greater family participation in collaborative care. The instrument consists of 6 dimensions: care for stabilization, continuity of follow-up, monitoring, detecting health changes, persistence in finding solutions, and symptom-relief evaluation. In the original study, internal consistency was reported as McDonald’s ω = 0.87. In the present study, internal consistency was high (McDonald’s ω = 0.91). The Persian version was prepared using forward-backward translation, and its face and content validity were confirmed by 10 faculty members in nursing and public health using the Waltz and Bausell method (CVI = 0.94, CVR = 0.84). For interpretation, the midpoint score was calculated using the formula (maximum - minimum)/2 + minimum.
The Stroke Self-Management Behaviors Questionnaire, developed by Lo et al. (
27), is a 9-item instrument scored on a 10-point scale from 0 (very dissatisfied) to 10 (very satisfied), with higher scores indicating better self-management behaviors. It includes 2 domains: medical management (3 items) and psychosocial management (6 items). In the original study, Cronbach α coefficients ranged from 0.65 to 0.88 across the subscales. In the present study, the instrument showed acceptable internal consistency (Cronbach α = 0.87). The Persian version was prepared using forward-backward translation, and its face and content validity were confirmed by 10 faculty members in nursing and public health using the Waltz and Bausell method (CVI = 0.96, CVR = 0.85). For interpretation, the midpoint score was calculated using the formula (maximum - minimum)/2 + minimum.
3.5. Statistical Analysis
Data were analyzed using SPSS version 27.0 (IBM Corp, Armonk, NY, USA). Descriptive statistics, including means and standard deviations (SDs), were used to summarize baseline clinical and demographic characteristics and the main study variables. Inferential analyses included one-sample t tests, independent-samples t tests, analysis of variance (ANOVA), and Pearson correlation coefficients.
Multiple linear regression analysis was used to evaluate the independent predictive capacity of family-participation subdimensions for self-management behaviors among post-stroke patients. Before conducting parametric tests and regression analyses, statistical assumptions were assessed. Normality was evaluated using the Kolmogorov-Smirnov test. Homoscedasticity and independence of residuals were assessed using residual plots and the Durbin-Watson statistic, respectively. Multicollinearity was assessed using the variance inflation factor (VIF), and all values were below the critical threshold of 10. Overall model effect size was evaluated using the coefficient of determination (R2), and 95% confidence intervals (CIs) were calculated for unstandardized regression coefficients (B). Statistical significance was set a priori at P < 0.05.
3.6. Ethical Considerations
The study was approved by the Ethics Committee of Ardabil University of Medical Sciences (IR.ARUMS.REC.1404.007). Participant anonymity and the right to withdraw were protected, and written informed consent was obtained from all participants.