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

Completed

• Conditions: Cardiac disease rehabilitation; Circulatory System; Cardiac disease

• Registration Number: ISRCTN70212111
• Lead Sponsor: Medtronic Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-03
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

1. Men and women aged 18 years or more
2. Due to receive an ICD
3. Provided consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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<br>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<br>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<br>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