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
Secondary identifying numbers	N/A

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

Study website

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

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	SEMAPHFOR (Self-management of heart failure for people with heart failure open randomisation)
Study objectives	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.
Ethics approval(s)	Huntingdon Research Ethics Committee, approved on 20/09/2005, ref: 05/Q0104/107
Health condition(s) or problem(s) studied	Heart Failure
Intervention	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).
Intervention type	Other
Primary outcome measure	The primary outcome is patient re-admission/admission to hospital within 12 months of randomisation.
Secondary outcome measures	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
Overall study start date	03/01/2006
Completion date	03/07/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	720
Key inclusion criteria	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.
Key exclusion criteria	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
Date of first enrolment	03/01/2006
Date of final enrolment	03/07/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of York

York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

Ms Sue Final
Intellectual Property Manager
Research Office
University of York
York
YO10 5DG
England
United Kingdom

Phone	+44 (0)1904 434401
Email	smf3@york.ac.uk
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Charity

British Heart Foundation (BHF) (UK) (ref: PG/03/098/15811)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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