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

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ClinicalTrials.gov Identifier: NCT04678128
Recruitment Status : Withdrawn (Not started)
First Posted : December 21, 2020
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Sanjiv Narayan, MD, PhD, Stanford University

Study Description
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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

Condition or disease Intervention/treatment Phase
ICD Anxiety Patient Engagement Behavioral: Dance4Healing Telehealth Live Zoom Sessions Behavioral: Dance Buddy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dance4Healing: A Pilot Study to Explore the Benefits of Tele-Dance in Individuals With an Implantable Cardioverter Defibrillator
Estimated Study Start Date : January 1, 2020
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Activity in hours/day from ICD interrogation as a measure of activity engagement over time [ Time Frame: 36 weeks ]
  2. 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

  3. 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 Outcome Measures :
  1. Change in Anxiety Score over time [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678128


Locations
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United States, California
Stanford Arrhythmia Clinic
Stanford, California, United States, 94303
Sponsors and Collaborators
Sanjiv Narayan, MD, PhD
Investigators
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Principal Investigator: Linda K Ottoboni, PhD Stanford Healthcare
More Information
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Responsible Party: Sanjiv Narayan, MD, PhD, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT04678128    
Other Study ID Numbers: IRB # 58348
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanjiv Narayan, MD, PhD, Stanford University:
ICD
Anxiety
QOL
Engagement