Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Sarah Cockayne
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SEMAPHFOR (Self-management of heart failure for people with heart failure open randomisation)
Study hypothesis
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
Huntingdon Research Ethics Committee, approved on 20/09/2005, ref: 05/Q0104/107
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
03/01/2006
Overall trial end date
03/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
720
Participant 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
Recruitment start date
03/01/2006
Recruitment end date
03/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of York
York
YO10 5DD
United Kingdom
Sponsor information
Organisation
University of York (UK)
Sponsor details
Ms Sue Final
Intellectual Property Manager
Research Office
University of York
York
YO10 5DG
United Kingdom
+44 (0)1904 434401
smf3@york.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK) (ref: PG/03/098/15811)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24508285
Publication citations
-
Results
Cockayne S, Pattenden J, Worthy G, Richardson G, Lewin R, Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomised controlled trial., Int J Nurs Stud, 2014, doi: 10.1016/j.ijnurstu.2014.01.010.