Effectiveness of a nurse-led temporal self-regulation theory-based program on heart failure self-care: A randomized controlled trial

Heart failure self-care is crucial for sustainable heart failure management but its adherence remains poor worldwide. Despite having an intention to change, individuals often face difficulties in modifying existing lifestyle habits and sustaining change motivations. To examine the effectiveness of a novel theory-driven nurse-led self-regulation program on improving heart failure self-care behaviours, future-thinking and behavioural automaticity. A two-arm randomized controlled trial. 144 patients with heart failure were recruited from September 2018 to July 2019 at a tertiary hospital in Singapore. Participants were randomly assigned to a self-regulation intervention (n = 72) or usual care group (n = 72). The three-month intervention was developed based on the temporal self-regulation theory and consisted of one face-to-face session, a print booklet and three reinforcement telephone follow-ups at week 3, 6 and 9. Outcomes were measured at baseline (T0), immediate after a three-month intervention (T1) and a further three-month follow-up (T2). heart failure self-care was measured using the Self-Care of Heart Failure Index (SCHFI) maintenance subscale, future-thinking was measured using the Consideration of Future Consequences Scale (CFCS) and behaviour automaticity was measured using the Self-Reported Behavioural Automaticity Index (SRBAI). The outcomes were compared between groups by using generalized estimating equations (GEE) based on intention-to-treat principle. No significant differences were found between the groups at baseline except for age. Participants were on average 61 years old, men (79.2%), had mild heart failure symptoms (50.7%) and had three comorbidities (66.0% dyslipidaemia; 65.3% hypertension; 61.8% history of myocardial infarction). Baseline scores indicated poor heart failure self-care (52.9±17.2, cut off ≥70). GEE results showed significantly higher heart failure self-care improvements in intervention group than control group at both T1 (regression coefficient, B = 13.9, 95% CI: 8.02 to 19.9, p < 0.001) and T2 (B = 8.34, 95% CI: 1.68 to 15.0, p = 0.014) after adjusting for gender, living alone, education level, comorbidity and age. Results also showed significantly higher increase in future-thinking (B[95% CI]=0.694[.123, 1.26], p = 0.017) and behaviour automaticity (B[95% CI]=0.656[.085, 1.23], p = 0.024) at T1 and only increase in behaviour automaticity (B[95% CI]=0.674[.099, 1.25], p = 0.022) at T2. However, only the differences in self-care scores at T1 remained significant after Bonferroni correction. No significant differences were found for intention, quality of life and clinical biomarkers. The program was effective in improving heart failure self-care and has potential for clinical implementation and generalisation to other chronic illnesses. Longer follow-up study is needed to uncover its long-term benefits on clinical outcomes.