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

NCT04678128 | Withdrawn

• 1 other identifier: IRB # 58348
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

ICD; Anxiety; Patient Engagement

Keywords

ICD; Anxiety; QOL; Engagement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Anxiety Score over time

  Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term)

Study Arms (2)

Dance4Healing control group

ACTIVE COMPARATOR

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

Dance4Healing Buddy Group

EXPERIMENTAL

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; Behavioral: Dance Buddy

Interventions

Dance4Healing Telehealth Live Zoom Sessions BEHAVIORAL

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.

Dance4Healing Buddy Group; Dance4Healing control group

Dance Buddy BEHAVIORAL

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.

Dance4Healing Buddy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Sanjiv Narayan, MD, PhD: lead

Study Sites (1)

Stanford Arrhythmia Clinic

Stanford, California, 94303, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Patient Participation

Condition Hierarchy (Ancestors)

Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Linda K Ottoboni, PhD

  Stanford Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)