Effects of a multimodal support intervention (the NICE-Support programme) on frailty and quality of life in patients with heart failure: a randomized controlled trial

AIMS: This randomized controlled trial examined the effectiveness of the 12-week NICE-Support programme-combining nutrition, nursing instruction, exercise, and support-on frailty and quality of life in patients with heart failure. METHODS AND RESULTS: A total of 240 adults (≥20 years) with stable heart failure, cognitive and physical capacity for activity, and smartphone access were recruited from two Taiwanese medical centres and randomly allocated to either the intervention group or the control group. The 12-week intervention included nutritional counselling, three in-person nursing consultations (40-60 min each), a structured exercise regimen (three 30 min sessions per week), social media support, and biweekly follow-up calls. The control group received standard nursing care and routine discharge education. Frailty and quality of life were assessed at baseline and at 4, 12, and 24 weeks to evaluate short-term and sustained effects. Among the 240 participants, 192 (80%) completed the 24-week follow-up. An intention-to-treat analysis was conducted to evaluate the intervention effects. Both groups showed significant improvements over time. At 24 weeks, the control group demonstrated significant improvements in frailty scores (-8.11 points) and overall quality of life scores (-22.71 points). Compared with the control group, the intervention group exhibited significantly greater improvements in frailty (Cohen's d = 1.17) and overall quality of life (Cohen's d = 0.87) at Week 24. CONCLUSION: The NICE-Support programme significantly reduces frailty and improves quality of life in patients with heart failure. Its integration into routine care is recommended. REGISTRATION: ClinicalTrials.gov: NCT05366686.