Contact information
Type
Scientific
Primary contact
Dr Dorothy Frizelle
ORCID ID
Contact details
The Department of Clincal Psychology
Postgraduate Medical Institute
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom
d.frizelle@hull.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MREC/03/2/053
Study information
Scientific title
Acronym
ICD-Plan Trial
Study hypothesis
To assess the effectiveness of a rehabilitation programme (the Implantable Cardiac Defibrillator [ICD]-Plan), for patients undergoing implantation of a cardiac defibrillator.
Ethics approval
Approval received from the London Multicentre Research Ethics Committee (MREC) on the 17th November 2003.
Study design
A prospective multicentred, intention-to-treat cluster randomised controlled trial of implantation centres to intervention or control.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiac disease rehabilitation
Intervention
The 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 type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Anxiety 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 measures
1. 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 trial start date
01/12/2003
Overall trial end date
31/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women aged 18 years or more
2. Due to receive an ICD
3. Provided consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
188
Participant exclusion criteria
1. 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
Recruitment start date
01/12/2003
Recruitment end date
31/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Department of Clincal Psychology
Hull
HU6 7RX
United Kingdom
Sponsor information
Organisation
Medtronic Ltd (UK)
Sponsor details
Suite 1
Sherbourne House
Croxley Business Park
Watford
WD18 9WW
United Kingdom
alison.scott@medtronic.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Medtronic Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18070951
Publication citations
-
Results
Lewin RJ, Coulton S, Frizelle DJ, Kaye G, Cox H, A brief cognitive behavioural preimplantation and rehabilitation programme for patients receiving an implantable cardioverter-defibrillator improves physical health and reduces psychological morbidity and unplanned readmissions., Heart, 2009, 95, 1, 63-69, doi: 10.1136/hrt.2007.129890.