A randomised controlled trial of a self-management programme for people with heart failure and their family carers

ISRCTN ISRCTN84692046
DOI https://doi.org/10.1186/ISRCTN84692046
Protocol serial number N/A
Sponsor University of York (UK)
Funder British Heart Foundation (BHF) (UK) (ref: PG/03/098/15811)
Submission date
06/10/2005
Registration date
03/11/2005
Last edited
17/02/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Sarah Cockayne
Scientific

University of York
Department of Health Sciences
BHF Care & Education Research Group
Area 4 Seebohm Rowntree Building
York
YO10 5DD
United Kingdom

+44 (0)1904 321736
sarah.cockayne@york.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study acronymSEMAPHFOR (Self-management of heart failure for people with heart failure – open randomisation)
Study objectivesThe primary objective is to assess the clinical effectiveness of the newly developed nurse facilitated, cognitive behavioural self-management programme in helping patients and their carers better manage the medical and psychological aspects of living with heart failure. To do this we will test the hypothesis that, patients using a cognitive behavioural self-management programme facilitated by a nurse will have fewer admissions to hospital, better self-management and an improved health related quality of life compared to patients receiving usual care.
Ethics approval(s)Huntingdon Research Ethics Committee, approved on 20/09/2005, ref: 05/Q0104/107
Health condition(s) or problem(s) studiedHeart Failure
InterventionParticipants will be randomised to either the nurse facilitated cognitive behavioural self-management programme or usual care from the heart failure nurse, with the same manual of information produced by the British Heart Foundation (BHF).
Intervention typeOther
Primary outcome measure(s)

The primary outcome is patient re-admission/admission to hospital within 12 months of randomisation.

Key secondary outcome measure(s)

1. Patient-related measures:
1.1. Minnesota Living with Heart Failure
1.2. EQ5D
1.3. Hospital Anxiety and Depression scale
1.4. European self-care form
1.5. Cardiac beliefs questionnaire
1.6. Patient satisfaction

2. Carer-related measures:
2.1. Caregiving Demands Scale
2.2. EQ5D

Completion date03/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration720
Key inclusion criteriaPatients who have a definitive diagnosis of symptomatic heart failure (left ventricular systolic dysfunction [LVSD]) as defined by ECHO, clinical diagnosis or coronary angiography within the past 24 months.
Key exclusion criteria1. There is written case record of cognitive deficits
2. They are unable to make decisions about their own care
3. They are unable to give informed consent
4. They are unable to read English
5. They are living in nursing homes
6. If the patient has a life-threatening concomitant condition
Date of first enrolment03/01/2006
Date of final enrolment03/07/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of York
York
YO10 5DD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2014 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes
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