Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): A randomised controlled trial

摘要

Objective: To compare the clinical effectiveness of a newly developed cognitive behavioural self-management manual delivered by specialist heart failure nurses or the same programme followed by the patient on their own, in terms of readmissions/admissions to hospital for any reason within a 12 month period, patient health related quality of life, self-management and carer quality of life. Design: Pragmatic, open parallel group, randomised controlled trial. Setting: Open access heart failure diagnostic clinics and primary care. Participants: 260 patients with a definitive diagnosis of symptomatic heart failure (LVSD) as defined by ECHO, clinical diagnosis or coronary angiography were eligible for the study. Intervention: A newly developed nurse facilitated, cognitive behavioural self-management programme was developed and was delivered either by a heart failure nurse or by the patient on their own. Main outcome measures: Patient admission/readmission to hospital for any reason within a 12 month period following randomisation. Secondary outcomes were: participant health related quality of life as measured by the Minnesota Living with Heart Failure questionnaire, the Hospital, Anxiety and Depression Scale, the European self-care form. Results: There was no evidence of a difference between the groups in whether or not a patient was re-admitted to hospital during the 12 month follow-up period (p=0.66). There was no evidence of a difference between the treatment groups in the mean MLHF scores over time (p=0.768), the European self-care questionnaire (p=0.340) or the mean HAD anxiety score (p=0.786). However, when adjusted for baseline scores the self-management group had a statistically significant higher HADS depression score at 12 months (p=0.003). Conclusion: There was no evidence of a difference in admissions/readmission to hospital between patients who undertook a brief heart failure self-management programme facilitated by a specialist heart failure nurse and those also receiving care from a specialist nurse who followed the programme on their own. Trial registration: This trial is registered as ISRCTN84692046.