Sarah Cockayne1, Jill Pattenden2, Gill Worthy3, Gerry Richardson4, Robert Lewin2. 1. York Trials Unit, Department of Health Sciences, University of York, UK. Electronic address: sarah.cockayne@york.ac.uk. 2. British Heart Foundation Care and Education Research Group, Department of Health Sciences, University of York, UK. 3. Kleijnen Systematic Reviews, Escrick Business Park, York, UK. 4. Centre for Health Economics, University of York, UK.
Abstract
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.
RCT Entities:
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.
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