Development and pilot testing of a nurse-led common-sense model of self-regulation-based heart failure self-care program

The development of nurse-led CSM of Self-Regulation-based HF self-care program was informed by a review of the relevant literature, the theoretical foundations of CSM of self-regulation, international and national guidelines, and the findings of our previous systematic reviews.

Study design. This study is a single-blinded, two-arm, parallel group, randomized controlled trial (RCT). Eligible participants were randomly assigned at a 1:1 ratio to either the intervention group or the control group via block randomization generated by an independent researcher. Allocation concealment was ensured with sequentially numbered, opaque sealed envelopes. A research nurse, blinded to the group assignments, collected the post-test data. The participants in the intervention group received a 6-week nurse-led CSM of Self-Regulation-based HF self-care program (details were presented in the result section) in addition to usual care (routine treatment and nursing, health education, and a telephone follow-up in the first week after the patient is discharged from hospital), whereas those in the control group received usual care only. Data were collected at baseline and immediately post-intervention. We evaluated the program’s feasibility, acceptability, and potential effects, and the study followed the CONSORT statement [25].

Setting and subjects. Participants were recruited using convenience sampling method in February 2023 at a university-affiliated hospital in China. HF patients admitted to the hospital were enrolled if they met the following criteria: (1) adults (aged ≥ 18 years), (2) clinically diagnosed with HF, (3) classified as New York Heart Association (NYHA) 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) agreed to participate in the study. Subjects were excluded if they had psychiatric diseases, severe physical illness other than HF, or were concurrently involved in other clinical trials. Hertzog (2008) [26] suggested that a minimum of 10 to 15 participants per group is needed for a pilot study. Thus, the sample size for this pilot study was set at 26 participants (13 in each group).

Outcome measures and data collection. The feasibility outcomes included (1) subject recruitment and retention: the eligibility rate, recruitment rate, retention rate, attrition rate, and the reasons for dropping out of the study; (2) intervention implementation: the time taken to complete each session, the percentage of participants who complete all the sessions, and reasons for discontinuing the sessions; and (3) data collection: the time taken to complete measures. The acceptability of the intervention was assessed at the end of the study using a self-designed questionnaire. The questionnaire gathered data on the participants’ perceptions of the intervention content, dosage, materials, and effects. Each item of the questionnaire was rated as strongly disagree, disagree, neither agree nor disagree, agree, or strongly agree. The intervention was considered acceptable if over 80% of participants rated it as “agree” or “strongly agree” for all items. Sociodemographic and clinical information and outcome variables were also collected. Sociodemographic data collected included age, gender, marital status, educational level, employment status, place of residence, living condition, smoking status, and alcohol intake status. The required clinical information included cause of HF, NYHA functional class, time since diagnosis, left ventricular ejection fraction, comorbidity (measured by the Charlson Comorbidities Index), number of hospitalizations, body mass index, blood pressure, heart rate, NT-ProBNP, total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol, urea, creatinine, HbA1C, and frailty (measured by the Tilburg Frailty Indicator). The study outcomes included illness perceptions (measured by the 9-item Brief Illness Perception Questionnaire [27]), self-care self-efficacy (measured by the 10-item Self Care Self-Efficacy Scale [28]), self-care behaviors (measured by the 29-item Self-Care of Heart Failure Index version 7.2 [29]), health-related quality of life (measured by the 21-item Minnesota Living with Heart Failure Questionnaire [30]), depression (measured by the 9-item Patient Health Questionnaire [31]), anxiety (measured by the 7-item Generalized Anxiety Disorder [32]), symptom burden (measured by the Memorial Symptom Assessment Scale-Heart Failure [33]), sleep quality (measured by the Pittsburgh Sleep Quality Index [34]), healthcare service utilization (the number of HF-related hospital readmissions, HF-related hospital days, HF-related emergency room visits, and HF-related unscheduled outpatient department visits), and mortality. Before the data collection, all eligible participants were informed of the purpose of the study and asked to sign the informed consent form. The principal investigator collected the baseline data through face-to-face interviews and the medical system, whereas a research nurse conducted post-test data collection via telephone interviews.

Data analysis. Statistical analyses were conducted using IBM SPSS version 27.0. A two-sided p < 0.05 was considered statistically significant. Normally distributed continuous variables are presented as the means and standard deviations, while non-normally distributed variables are described as medians and interquartile range (IQR). Categorical variables are presented as frequency and percentage. The intention-to-treat principle was used to analyze the data. The homogeneity between groups was tested by an independent t‐test or Fisher’s exact test as appropriate. Generalized estimating equation (GEE) models were used to compare the differential changes in outcome variables including illness perceptions, self-care self-efficacy, self-care behaviors, quality of life, depression, anxiety, symptom burden, and sleep quality between groups across the time points. The Mann–Whitney U test was used to compare the number of HF-related hospital readmissions between the intervention and control groups.

Concept of HF self-care. The concept of HF self-care was identified and conceptualized according to the Situation-Specific Theory of Heart Failure Self-Care [35]. As described in this theory, HF self-care refers to the process of managing one’s health through self-care maintenance, symptom perception, and self-care management. It encompasses the behaviors involved in sustaining the stability of physiological health (self-care maintenance), monitoring and recognizing symptoms (symptom perception), and managing the onset of symptoms (self-care management).

Core components of HF self-care. The core components of HF self-care were derived from a practical guideline organized around key aspects of HF self-care (self-care maintenance, symptom perception, and self-care management) [36]. The recommendations focus primarily on the following areas: body weight and nutritional status, fluid and salt intake, exercise tolerance, smoking cessation and prevention of excessive drinking, immunization, medication adherence, psychological status, sleep, travel, leisure activity, and sexual activity, symptom monitoring, and appropriate responses to symptoms. Accordingly, the intervention content was designed by adopting these recommendations. Additionally, the content was adjusted in accordance with the recommendations provided by the Chinese guidelines for HF management [37, 38].

Illness perception includes both cognitive and emotional aspects. Cognitive perceptions are proposed to regulate objective health threats, while emotional perceptions are regarded as adjusters of negative emotions. There are eight dimensions of cognitive perceptions: identity, consequences, causes, timeline, personal control, treatment control, and illness coherence. Each dimension is independent but also interrelated. Emotional perceptions capture the negative emotional responses evoked by illness, and they can independently influence coping procedures and disease outcomes alongside cognitive perceptions [21]. Self-efficacy is posited to moderate the effects of cognitive and emotional perceptions on the enactment of coping procedures. Researchers suggest that when people’s representations of their illness evoke awareness such that they enact coping behaviors, they also form or activate representations of these coping behaviors, which include beliefs about the performance of particular behaviors [21].

Evidence base. We conducted a systematic review to evaluate the effectiveness of nurse-led self-care interventions for people with HF and identify potentially effective characteristics to inform intervention development [7, 8].

Our systematic review indicated that the core components of effective self-care interventions typically include assessment, self-care knowledge and skills, problem-solving, decision-making, goal-setting, action-planning, reminders, monitoring, feedback, and social support. These elements have been shown to promote behavior changes and improve patient outcomes. On the basis of subgroup analysis, we determined that the optimal duration for self-care interventions is usually one to three months. We chose a 6-week duration with reference to Jiang et al. [39], as previous research has shown this timeframe to yield the greatest improvements in health outcomes for HF patients. Our review also indicated that nurse-led self-care interventions are often delivered to individual participants via face-to-face approach in hospitals and telephone calls after discharge. Thus, we provided individual participants with face-to-face discharge education during their hospital stay and followed up with phone calls after discharge. The review suggested that effective face-to-face interventions typically include one to five sessions, each lasting 15 to 90 min, occurring weekly or biweekly. Follow-up sessions were recommended to be between two to eight, lasting 10 to 45 min, and scheduled twice a week to monthly. Owing to the short hospital stays and patients’ unstable conditions early in their admission, we could only provide one predischarge session, which was set to last one hour to cover the necessary content. To offer ongoing support and monitor adherence to self-care without overwhelming participants, we conducted one 20-minute reinforcement telephone follow-up session in the first week after discharge, followed by two more 20-minute sessions every two weeks.

Conceptualization of the study intervention. The potentially effective strategies identified in our previous systematic review were adopted to address illness perceptions and self-efficacy (Supplementary Table 1). The theoretical framework underpinning the proposed program is described in Supplementary Fig. 1. We anticipated that improvements in illness perceptions and self-efficacy would subsequently enhance the participants’ self-care behaviors and improve their prognosis, such as health-related quality of life, depression, anxiety, symptom burden, sleep quality, healthcare service utilization, and mortality.

Description of the study intervention. The 6-week nurse-led CSM of the self-regulation-based HF self-care program consisted of one 60-min face-to-face individual education session in the hospital (week 1) followed by one 20-min weekly (week 2) and two 20-min biweekly (week 4 and week 6) reinforcement telephone follow-up sessions after discharge (Supplementary Table 2). All the sessions were uniformly delivered by the principal investigator to ensure consistency.

The participants received educational handbooks and self-care logbooks (Supplementary Fig. 2). The education handbook contains three sections, namely HF disease management information, HF self-care knowledge and skills training, and behavior change techniques. The HF disease management information section gave information on the definition, causes, clinical manifestations, physical and psychological impacts, course of HF, and on treatments for HF. The HF self-care knowledge and skills training section focused on key HF self-care topics, including 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. The behavior change techniques section presents details on problem-solving, decision-making, goal-setting, and action-planning. 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. A panel of experts in the field of cardiovascular care and a group of laypeople reviewed the education handbook and self-care logbook. The content validity of the education handbook and self-care logbook was evaluated using the content validity index (CVI) [40]. The item-level CVI, scale level-CVI/universal agreement, and scale level-CVI/Average all scored one in our study, indicating strong content validity. Participants also reported that the intervention contents were clear and understandable.

Baseline data of the participants. The mean age of the participants was 60.23 years (SD = 13.44), with the majority being male (69.2%). Only four subjects (15.4%) had tertiary education or higher, and more than half of the patients (69.2%) were unemployed. Almost all participants were married (96.2%), most dwelt in urban areas (92.3%), and all resided with others. Tables 1 and 2 present the characteristics of the participants and the study outcomes from the pilot study. There were no significant between-group differences in participants’ characteristics or study outcomes.

Feasibility of subject recruitment and retention. A total of 34 potential participants were identified through medical records. Seven patients were excluded based on the eligibility criteria, and one declined to participate. Finally, 26 participants were enrolled and signed the informed consent form. The eligibility rate was 79.4% (27/34) and the recruitment rate was 96.3% (26/27). The reasons for exclusion included chronic kidney disease stage 4 (n = 3), inability to communicate (n = 2), recent participation in other research (n = 1), and mobility issues (n = 1).

After collecting baseline data, all 26 enrolled participants were randomly assigned to either the intervention group (n = 13) or the control group (n = 13). One participant in the intervention group withdrew due to an acute exacerbation of HF that required hospitalization, and one subject in the control group was lost to follow-up after not answering phone calls. Ultimately, 24 participants completed the immediate post-intervention assessment, resulting in a retention rate of 92.3% (24/26) and an attrition rate of 7.7% (2/26) for this pilot study (Fig. 1).

Twelve participants completed a questionnaire to assess the intervention’s acceptability. All but two participants agreed or strongly agreed with all the items listed in the questionnaire, indicating an acceptance rate of 83.3%. None rated any items as strongly disagreed or disagreed (Supplementary Table 3). In addition, four participants provided suggestions on this program. One suggested making the recommended foods for individuals with heart failure more specific, so we added more examples to the educational handbook. The other three felt it was unnecessary to record their performance in the self-care logbook, even after completing the tasks.

Potential effects. Compared with the controls, the participants in the intervention group had statistically significant improvements in illness perceptions (β=-11.837, 95% CI: -16.747, -6.928, P < 0.001), self-care self-efficacy (β = 9.838, 95% CI: 6.088, 13.588, P < 0.001), self-care maintenance (β = 10.969, 95% CI: 1.238, 20.699, P = 0.027), symptom perception (β = 17.422, 95% CI: 10.265, 24.579, P < 0.001), and self-care management (β = 17.231, 95% CI: 10.279, 24.184, P < 0.001). However, there were no significant changes in health-related quality of life, depression, anxiety, symptom burden, or sleep quality (Table 3). The Mann–Whitney U test showed no significant difference in the number of HF-related hospital readmissions between the two groups (P = 0.317). No deaths or other healthcare service utilization outcomes were reported.