COPE-ICD: A randomised clinical trial studying the effects and meaning of a comprehensive rehabilitation programme for ICD recipients -design, intervention and population
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Key result
This study protocol describes the design and baseline characteristics of 196 patients enrolled in the COPE-ICD trial, which is designed to evaluate the effects of a comprehensive rehabilitation program on perceived health and physical capacity in first-time ICD recipients.
Why the study?
Does a comprehensive rehabilitation programme (psycho-educational intervention and exercise training) improve perceived health and peak VO2 in first-time ICD recipients?
Population
196 patients receiving an implantable cardioverter defibrillator for the first time, mean age 58, 79% men…
Comparison
COPE-ICD programme: 1-year psycho-educational… vs Standard care, with no psycho-educational…
Design
RCT, Block of 4 by voice-respondent in a 1:1 ratio to intervention group or…
Follow-up
12 months (with registry data up to 2 years)
Authors
Discussion
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Implication
The COPE-ICD trial is a large-scale randomized study designed to evaluate the effects of a comprehensive psycho-educational and exercise rehabilitation program on perceived health and physical capacity in first-time ICD recipients.
Study Design
Type
RCT (n=196)
Blinding
Single-blind (blinded investigator for physical tests and data collection)
Randomization
Block randomization (block of 4) in a 1:1 ratio, stratified by gender and LVEF
Multicenter
No
Structured PICO
Does a comprehensive rehabilitation programme (psycho-educational intervention and exercise training) improve perceived health and peak VO2 in first-time ICD recipients?
P
Population
196 adults (mean age 58, 21% female) receiving their first implantable cardioverter defibrillator at a single center in Denmark, randomized to a comprehensive rehabilitation program or standard care.
I
Intervention
COPE-ICD programme: 1-year psycho-educational component (nurse consultations) and 12-week exercise training component (twice a week).
C
Comparator
Standard care (medical follow-up and an invitation to participate in a 2-hour group meeting), with no psycho-educational follow-up or exercise training.
O
Outcome
Perceived health measured by the Short Form-36 (SF-36) questionnaire and Peak VO2 measured by a standardized bicycle ergometer protocol.patient reported
The COPE-ICD trial is a large-scale randomized study designed to evaluate the effects of a comprehensive psycho-educational and exercise rehabilitation program on perceived health and physical capacity in first-time ICD recipients.
Limitations
- Selection bias may exist due to exclusion of patients already included in pharmaceutical trials
- Control group might be contaminated by information given during project inclusion, potentially leading them to seek rehabilitation elsewhere
- Expected drop-out rate of 20% could influence validity
- Trial is designed with multiple statistical comparisons, requiring cautious interpretation of results
- Selection bias may exist due to patients not being included if they were already included in a pharmaceutical trial.
- The control group might be contaminated by the information given during the project inclusion.
- The intervention is expensive from a rehabilitation perspective.
Cite This Study
Berg et al. (2011) conducted an RCT in First-time implantable cardioverter defibrillator (ICD) recipients (n=196). COPE-ICD comprehensive rehabilitation program vs. Standard care was evaluated on Perceived health measured by the SF-36 questionnaire and Peak VO2. This study protocol describes the design and baseline characteristics of 196 patients enrolled in the COPE-ICD trial, which is designed to evaluate the effects of a comprehensive rehabilitation program on perceived health and physical capacity in first-time ICD recipients.
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