Anxiety, ICD, Patient Engagement
Conditions
Keywords
ICD, Anxiety, QOL, Engagement
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
Interventions
BEHAVIORALDance4Healing Telehealth Live Zoom Sessions
Week 1: 2-hour introduction session on Zoom platform with a live dance instructor at the participant's desired level of activity intensity (low, mild, or moderate). Weeks 2-8: All participants will be asked to participate in a 1 hour online, instructor-led live class.
BEHAVIORALDance Buddy
Following randomization (beginning of intervention period) half of the participants will be assigned a dance buddy, and will be asked to dance with their buddies using the Dance4Healing TLVP at least 2 additional times/week. This group will have 24/7 access to Dance4Healing Platform during the intervention and post-intervention periods.
Sponsors
Sanjiv Narayan, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients that have had an ICD implanted for at least 1 month 2. Patients have access to web-based on-line programs 3. 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. 4. Patient is 18 years old or greater.
Exclusion criteria
1. Patient is non-English speaking. 2. Patient is assessed as having NYHA Class IV heart failure. 3. Patient had ventricular tachycardia (VT), ventricular fibrillation (VF) or has received tachy therapy from their ICD within last 4 weeks. 4. Patient has had a change in medical arrhythmia management or ablation procedure within the last 4 weeks. 5. Any medical issues that compromise walking or dancing, including cardiac, neurological or orthopedic .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity in hours/day from ICD interrogation as a measure of activity engagement over time | 36 weeks | — |
| Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time | 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 |
| Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention | Total time in minutes over the 8 week intervention period | Total number of minutes that the participant accesses the Dance4Healing platform each week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Score over time | Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term) | Anxiety will be a calculated score from a 10 question self-reported questionnaire (Florida Shock Anxiety Scale) with a scoring range from 0-50, with higher scores indicating more anxiety. |
Countries
United States
Outcome results
None listed