跳至主要内容
临床试验/NCT05972070
NCT05972070招募中不适用

Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence

ROM Technologies, INC1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Session attended

研究概览

简要总结

The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.

详细描述

The focus of this study is to determine the feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. The study consists of an initial review, rehabilitation sessions, nutrition consultation, and risk stratification. Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device exercises.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over the age of 18
  • NYHA Functional Class I, II,
  • Recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation)
  • Candidate for traditional center-based cardiac rehabilitation

排除标准

  • Under the age of 18
  • Adults lacking capacity to consent.
  • NYHA Functional Class III, IV
  • Acute coronary syndrome
  • Systolic heart failure (LV EF <40%)
  • Status post cardiac surgery for structural heart disease or heart transplant
  • Percutaneous coronary angioplasty
  • Adults lacking capacity to consent.
  • Pregnant women

结局指标

主要结局

Session attended

时间窗: 12 weeks (End of treatment)

Measure the number of sessions attended to determine the ease of patients to utilize home-based cardiac rehab integrated with telemedicine (non-inferiority to historical controls)

Duke Activity Status Index (DASI)

时间窗: Baseline, 12 weeks (End of Treatment)

Estimate of functional capacity

Sessions completed

时间窗: 12 weeks(End of treatment)

Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine

Short Physical Performance Battery

时间窗: Baseline, 12 weeks (End of Treatment)

Lower extremity functional assessment

Patient Health Questionnaire(PHQ)

时间窗: Baseline, 12 weeks (End of Treatment)

Quality of Life assessment

Short Form-36

时间窗: Baseline, 12 weeks (End of Treatment)

Quality of Life assessment

次要结局

  • Laboratory assessment(Baseline, 12 weeks (End of Treatment))

研究者

发起方
ROM Technologies, INC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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