Dance4Healing: a Pilot Study to Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter Defibrillator
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
Study Overview
Brief Summary
This study is to determine if it is feasible to using a Telehealth Dance Platform with patients that have an implantable Cardioverter Defibrillator, and will compare the activity engagement, anxiety, and Quality of Life
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients that have had an ICD implanted for at least 1 month
- •Patients have access to web-based on-line programs
- •Patient can provide cardiac clearance for exercise from their treating physician OR they have written stress test results from within the last 6 months indicating no ischemia.
- •Patient is 18 years old or greater.
Exclusion Criteria
- •Patient is non-English speaking.
- •Patient is assessed as having NYHA Class IV heart failure.
- •Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received "tachy" therapy from their ICD within last 4 weeks.
- •Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks.
- •Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .
Outcomes
Primary Outcomes
Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
Time Frame: Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)
Scores range from 0-100, higher scores represent higher engagement self reported survey
Activity in hours/day from ICD interrogation as a measure of activity engagement over time
Time Frame: 36 weeks
Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention
Time Frame: Total time in minutes over the 8 week intervention period
Total number of minutes that the participant accesses the Dance4Healing platform each week
Secondary Outcomes
- Change in Anxiety Score over time(Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term))
Investigators
Sanjiv Narayan, MD, PhD
Professor of Medicine
Stanford University