Dance4Healing: a Pilot Study to Explore the Benefits of Tele-Dance in Individuals with an Implantable Cardioverter Defibrillator
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 .
研究组 & 干预措施
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.
干预措施: Dance4Healing Telehealth Live Zoom Sessions (Behavioral)
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.
干预措施: Dance4Healing Telehealth Live Zoom Sessions (Behavioral)
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.
干预措施: Dance Buddy (Behavioral)
结局指标
主要结局
Change in calculated score from Patient Activation as a measure of Patient Activity Engagement over time
时间窗: 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
Activity in hours/day from ICD interrogation as a measure of activity engagement over time
时间窗: 36 weeks
Total Amount of Time spent accessing the dance platform in minutes as a measure of Activity Engagement during the study intervention
时间窗: Total time in minutes over the 8 week intervention period
Total number of minutes that the participant accesses the Dance4Healing platform each week
次要结局
- Change in Anxiety Score over time(Baseline, Week 8(pre-intervention), Week 16 (post-intervention), Week 28 (long term))
研究者
Sanjiv Narayan, MD, PhD
Professor of Medicine
Stanford University