Arrhythmias & electrophysiologyRandomised controlled trial
Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial
- Randomised controlled trial
- multicentre
- stratified for age, gender and indication for ICD placement
Authors' conclusion
Although the primary outcome was neutral, this is the first RCT showing that WBI can improve psychosocial well-being in ICD patients.
Study context
- Population
- ICD patients with elevated psychosocial distress (HADS anxiety or depression subscale ≥6 or Satisfaction with Life Scale (SWLS) ≤16), 7 German sites; mean age 58.8 ± 11.3 years, 22% women
- Participants
- 118 patients · 7 German sites
- Comparison
- Web-based intervention vs usual care
- Primary endpoint
- Composite of:
- Change in heart-focused fear
- Depression
- Mental quality of life (QoL)
- Follow-up
- 6 weeks after randomization
Primary result
As reported in the abstract
6 weeks
Primary outcome similar between groups (ηp2)
0.001
Further findings
| Outcome | P value |
|---|---|
| Overprotective support, change pre-intervention to 6 weeks · WBI superior; ηp2 = 0.036 | P = 0.004 |
| Change pre-intervention to 1 year: depression, self-management, overprotective support — WBI vs UC · depression; WBI superior; ηp2 = 0.032 | P = 0.004 |
| Change pre-intervention to 1 year: depression, self-management, overprotective support — WBI vs UC · self-management; WBI superior; ηp2 = 0.015 | P = 0.03 |
| Change pre-intervention to 1 year: depression, self-management, overprotective support — WBI vs UC · overprotective support; WBI superior; ηp2 = 0.031 | P = 0.02 |
| Change 6 weeks to 1 year: depression, anxiety, mobilization of social support — WBI vs UC · depression; WBI superior; ηp2 = 0.026 | P = 0.02 |
| Change 6 weeks to 1 year: depression, anxiety, mobilization of social support — WBI vs UC · anxiety; WBI superior; ηp2 = 0.022 | P = 0.03 |
| Change 6 weeks to 1 year: depression, anxiety, mobilization of social support — WBI vs UC · mobilization of social support; WBI superior; ηp2 = 0.018 | P = 0.047 |
Original publication
Efficacy of a web-based intervention for improving psychosocial well-being in patients with implantable cardioverter-defibrillators: the randomized controlled ICD-FORUM trial. Eur Heart J. Published 8 April 2019. doi:10.1093/eurheartj/ehz134
Summarised from the published abstract; every number is checked against it