The Copenhagen Outpatient ProgrammE-Implantable Cardioverter Defibrillator trial was a randomized clinical trial that compared a complex rehabilitation intervention including exercise training and psychoeducational interventions with usual care. A significant difference between rehabilitation and usual care was found in physical capacity and general and mental health. However, the clinical effect sizes of these findings were not investigated, and the findings from the quantitative and qualitative analyses were not triangulated to address the issue of whether the qualitative results could help explain the quantitative results and bring forward additional information.
The objectives are to (a) determine the clinical effect sizes of the primary outcomes and (b) triangulate the quantitative and qualitative findings.
A total of 196 patients with first-time implantable cardioverter defibrillator implantation were randomized (1:1) to comprehensive cardiac rehabilitation (12 weeks of exercise training and 1 year of psychoeducational follow-up) versus treatment as usual. Two primary outcomes, perceived health (Short Form-36) and peak oxygen uptake, were used. Cohen d was calculated. Qualitative interviews were conducted with 10 patients representing the rehabilitation group. Triangulation was carried out by integrating the findings from the quantitative and qualitative results in light of each other.
Clinically meaningful effects were found between groups in peak oxygen uptake, general health, and mental health in favor of the rehabilitation group. Within groups, we found medium/high effect sizes on the mental component score in the rehabilitation group over time and only a small effect in the usual care group. The mechanisms of these effects were further explained by the qualitative findings. Patients with better physical health learned how to interpret body signals and adjust exercise behavior and experienced increased physical capacity. Those with better mental health received support that assisted them to cope with the possibility of shock and death and regain trust in their bodies.
The program has a clinical effect and is perceived as beneficial through supportive coping.
Selina Kikkenborg Berg, PhD Post Doc, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark.
Philip Moons, PhD, Professor, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark, and Centre for Health Services and Nursing Research, KU Leuven–University of Leuven, Belgium.
Anne Vingaard Christensen, MSc Public Health Research Assistant, The Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark.
Ann-Dorthe Zwisler, PhD Senior Researcher, Department of Cardiology, Holbæk University Hospital, University of Copenhagen, Denmark.
Birthe D. Pedersen, PhD Associate Professor, Research Unit of Nursing, Institute of Clinical Research, University of Southern Denmark, Odense.
Preben Ulrich Pedersen, PhD Professor, Centre of Clinical Guidelines–Clearinghouse, Faculty of Medicine and Technology, Aalborg University, Denmark.
This work was supported by the Novo Nordisk Foundation, the Oticon Foundation, the Danish Heart Foundation, the AP Møller and Chastine Mc-Kinney Møller Foundation, Helsefonden, the Tryg Foundation, the Krista and Viggo Petersen Foundation, The Danish Cardiovascular Research School, and the King Christian X Foundation and Rigshospitalet, Copenhagen University Hospital.
The authors have no conflicts of interest to disclose.
Correspondence Selina Kikkenborg Berg, PhD, The Heart Centre, Unit 2152, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark (email@example.com).