Condition category
Circulatory System
Date applied
06/10/2005
Date assigned
03/11/2005
Last edited
17/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cardiacrehabilitation.org.uk/

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 measures

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

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24508285

Publication citations

  1. 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.

Additional files

Editorial Notes