Dance4Healing: Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter-defibrillator (ICD)

Study Overview
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Brief Summary
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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

Official Title
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Dance4Healing: A Pilot Study to Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter Defibrillator

Conditions
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ICD, Anxiety, Patient Engagement

Intervention / Treatment
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* Behavioral: Dance4Healing Telehealth Live Zoom Sessions
* Behavioral: Dance Buddy


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dance4Healing control group<br>Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results). During the intervention period, this group will not have a dance buddy. | Behavioral: Dance4Healing Telehealth Live Zoom Sessions<br>* 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.<br>|
| Experimental: Dance4Healing Buddy Group<br>Participants will monitor their heart rate for 8 weeks (pre-intervention period), then engage in weekly live zoom dance sessions on digital Dance4Healing platform for 8 consecutive weeks (intervention period), then may elect to continue with monitoring for an additional 12 weeks (3-month post-intervention period for long-term results). During the intervention period, this group will have a dance buddy. | Behavioral: Dance4Healing Telehealth Live Zoom Sessions<br>* 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.<br>Behavioral: Dance Buddy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Scores range from 0-100, higher scores represent higher engagement self reported survey | Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term) | 
| Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention | Total number of minutes that the participant accesses the Dance4Healing platform each week | Total time in minutes over the 8 week intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety Score over time | 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. | Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, Anxiety, QOL, Engagement