Evaluation of a self-help, home-based comprehensive rehabilitation programme for Implantable Cardiac Defibrillator patients

ISRCTN ISRCTN70212111
DOI https://doi.org/10.1186/ISRCTN70212111
Secondary identifying numbers MREC/03/2/053
Submission date
16/05/2007
Registration date
03/07/2007
Last edited
11/12/2008
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

Dr Dorothy Frizelle
Scientific

The Department of Clincal Psychology
Postgraduate Medical Institute
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom

Email d.frizelle@hull.ac.uk

Study information

Study designA prospective multicentred, intention-to-treat cluster randomised controlled trial of implantation centres to intervention or control.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymICD-Plan Trial
Study objectivesTo assess the effectiveness of a rehabilitation programme (the Implantable Cardiac Defibrillator [ICD]-Plan), for patients undergoing implantation of a cardiac defibrillator.
Ethics approval(s)Approval received from the London Multicentre Research Ethics Committee (MREC) on the 17th November 2003.
Health condition(s) or problem(s) studiedCardiac disease rehabilitation
InterventionThe ICD Plan:
Healthcare staff in the intervention centres participated in a half-day training session delivered by a clinical psychologist. Training utilised a mixed format utilising presentations, case studies, role-playing and scenarios. The training addressed a number of issues including risk factors and their reduction, the psychology of cardiac disease, cardiac concerns and misconceptions, goal setting and pacing, the over-activity and rest cycle, self-management of anxiety and low mood, basic breathing and relaxation techniques and basic principles of cognitive-behavioural therapy.

The ICD Plan consisted of three patient held booklets, a goal-setting diary and relaxation tape or CD:
1. The first booklet was given to patients whilst awaiting implantation. It dealt with common fears experienced by patients prior to surgery. These were identified from consultation with ICD patients themselves, healthcare staff and the research literature and explained the device. It targeted the ICD concerns that have been shown to lead to increased disability and anxiety and depression and introduced relaxation and better breathing to help patients cope with the ‘stress’ of surgery and ICD implantation
2. The second booklet was a short one for relatives and carers detailing how they could help
3. The third booklet explained the best way ‘to get back to normal and avoid further problems’. It was a cognitive-behavioural rehabilitation programme in self-help form. The Facilitator and the patient, and when possible the family discussed the patients’ rehabilitation needs and set some simple initial goals
4. The goal setting diary was structured to be 12 weeks in length. The manuals are a self-help plan and can be worked through at the patients own pace

The patient and facilitator made contact three more times to discuss progress and set new goals.

Control:
Patients in the control group received care as usual.

Both groups also received a written information booklet by the British Heart Foundation (BHF) on how to manage ICDs. This booklet is available in the public domain.

Both intervention and control group received follow-up at the same time intervals using the measures. These time intervals were:
1. Pre-implantation questionnaire
2. Post-implantation questionnaire
3. Three-month follow-up questionnaire
4. Six-month follow-up questionnaire
Intervention typeOther
Primary outcome measureAnxiety and depression, the primary outcome, was measured using the Hospital Anxiety and Depression Scale (HADS). HADS is a 20-item instrument with two subscales measuring anxiety and depression with higher scores indicating greater psychological morbidity. A score of eight or more on either subscale indicates borderline case-ness for anxiety or depression. This was measured at pre-implantation, post-implantation, and three- and six-month follow-up.
Secondary outcome measures1. Health related quality of life was measured using the 12-item Short Form health survey (SF-12), measured at pre-implantation, post-implantation, and three- and six-month follow-up
2. Changes in the functional status of the sample was measured using the physical limitations subscale of the Seattle Angina Questionnaire (SAQ), measured at pre-implantation, post-implantation, and three- and six-month follow-up
3. Data on the number of shocks and ICD storms (three or more ICD shocks in any 24 hour period) in the six months following implantation were provided by the electrophysiologist at each centre
4. Service utilisation was measured using self-completed questionnaires developed for the measurement of health economic events in randomised controlled trials, measured at pre-implantation, post-implantation, and three- and six-month follow-up
Overall study start date01/12/2003
Completion date31/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants188
Key inclusion criteria1. Men and women aged 18 years or more
2. Due to receive an ICD
3. Provided consent
Key exclusion criteria1. Angina pectoris, Canadian Cardiovascular Society (CCS) class III and IV
2. New York Heart Association (NYHA) functional class IV
3. Cognitive impairment (judgement by clinician)
4. Inability to participate in a regular rehabilitation program at discharge
5. Inability to understand English
6. Exercise limitations due to clinical conditions not related to Coronary Artery Disease (CAD)
7. Known exercise-induced tachyarrhythmias
8. Cardiomyopathy associated with haemodynamic obstruction
9. Any major non-cardiac condition, that would adversely affect survival during the duration of the study
10. Patients unlikely to comply to the study and/or follow-up visits (including abuse of any substances)
11. Participation in a concurrent investigational research study or cardiac rehabilitation programme
Date of first enrolment01/12/2003
Date of final enrolment31/01/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Department of Clincal Psychology
Hull
HU6 7RX
United Kingdom

Sponsor information

Medtronic Ltd (UK)
Industry

Suite 1
Sherbourne House
Croxley Business Park
Watford
WD18 9WW
United Kingdom

Email alison.scott@medtronic.com
Website http://www.medtronic.co.uk/UK/
ROR logo "ROR" https://ror.org/00grd1h17

Funders

Funder type

Industry

Medtronic Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2009 Yes No