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

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

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 Overview

• Status: Withdrawn
• Conditions: Anxiety; Patient Engagement; ICD
• Intervention / Treatment: Behavioral: Dance4Healing Telehealth Live Zoom Sessions; Behavioral: Dance Buddy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94303
      • Stanford Arrhythmia Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dance4Healing control group; 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; 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.
Experimental: Dance4Healing Buddy Group; 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; 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.; Behavioral: Dance 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Sanjiv Narayan, MD, PhD
• Investigators: Principal Investigator: Linda K Ottoboni, PhD, Stanford Healthcare

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; ICD; Engagement; QOL
• Other Study ID Numbers: IRB # 58348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No