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ISRCTN
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ISRCTN84692046
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of a self-management programme for people with heart failure and their family carers
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Scientific title
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Acronym
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SEMAPHFOR (Self-management of heart failure for people with heart failure – open randomisation)
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Serial number at source
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N/A
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Study hypothesis
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The 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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Heart Failure
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Participants - inclusion criteria
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Patients 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.
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Participants - exclusion criteria
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1. 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
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Anticipated start date
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03/01/2006
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Anticipated end date
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03/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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720
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Interventions
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Participants 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).
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Primary outcome measure(s)
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The primary outcome is patient re-admission/admission to hospital within 12 months of randomisation.
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Secondary outcome measure(s)
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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
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Sources of funding
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British Heart Foundation (BHF) (UK) (ref: PG/03/098/15811)
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Trial website
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http://www.cardiacrehabilitation.org.uk/
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Publications
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Contact name
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Prof
Robert
Lewin
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Address
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University of York
Department of Health Sciences
BHF Care & Education Research Group
Area 4 Seebohm Rowntree Building
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Tel
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+44 (0)1904 32 1393
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Fax
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+44 (0)1904 32 1388
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Email
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rjpl1@york.ac.uk
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Sponsor
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University of York (UK)
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Address
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Ms Sue Final
Intellectual Property Manager
Research Office
University of York
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City/town
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York
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Zip/Postcode
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YO10 5DG
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Country
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United Kingdom
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Tel
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+44 (0)1904 434401
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Fax
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+44 (0)1904 435101
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Email
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smf3@york.ac.uk
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Date applied
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06/10/2005
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Last edited
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17/09/2009
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Date ISRCTN assigned
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03/11/2005
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