title: Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomised controlled trial.
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.
  
  
  METHODS
  Pragmatic, open parallel group, randomised controlled trial.
  
  
  METHODS
  Open access heart failure diagnostic clinics and primary care.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial is registered as ISRCTN84692046.
authors: York Trials Unit, Department of Health Sciences, University of York, UK. Electronic address: sarah.cockayne@york.ac.uk.
authors: Sarah
authors: S
authors: Cockayne
authors: British Heart Foundation Care and Education Research Group, Department of Health Sciences, University of York, UK.
authors: Jill
authors: J
authors: Pattenden
authors: Kleijnen Systematic Reviews, Escrick Business Park, York, UK.
authors: Gill
authors: G
authors: Worthy
authors: Centre for Health Economics, University of York, UK.
authors: Gerry
authors: G
authors: Richardson
authors: British Heart Foundation Care and Education Research Group, Department of Health Sciences, University of York, UK.
authors: Robert
authors: R
authors: Lewin
mesh_terms: D000368:Aged; D017028:Caregivers; D005260:Female; D006333:Heart Failure / Q000451:nursing / Q000523:psychology*; D006760:Hospitalization; D006801:Humans; D008297:Male; D008370:Manuals as Topic; D010359:Patient Readmission; D011788:Quality of Life; D012648:Self Care / Q000379:methods*
keywords: Cognitive behavioural self-management programme; Heart failure; Randomised controlled trial