Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Adherence (Primary Feasibility/Safety Outcome)
研究概览
简要总结
The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.
详细描述
The aim of this study is to investigate the feasibility and initial efficacy of a multicomponent tele-rehabilitation program during COVID-19 recovery. The tele-rehabilitation program will include biobehavioral training and high intensity exercise facilitated through an online application ('Platform'). Initial efficacy will be assessed primarily by performance on the 30" Chair Stand Test and secondarily through other physical function tests and patient reported outcome measures.
This study will advance the feasibility of tele-rehabilitation as a more generally useful intervention in patients lacking access (distance, availability, mobility) to standard rehabilitative services and could transform the way in which acute rehabilitation and post-hospital care is delivered for all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID-19, per diagnostic criteria (PCR testing)
- •Hospitalized for at least 24 hours
- •Able to provide informed consent
- •Internet capability to access the platform
- •Community-dwelling prior to hospitalization
排除标准
- •Unstable medical comorbidities that would preclude participation in exercise
- •Receipt of >1 session of outpatient physical therapy
- •Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19
- •Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)
结局指标
主要结局
Adherence (Primary Feasibility/Safety Outcome)
时间窗: 12 weeks
Feasibility will be measured by program adherence, defined as the number of sessions attended divided by the total number of prescribed sessions (n=12). Individuals will be considered adherent if they attend at least 75% (n=9) of the total sessions. Adherence will be collected in the intervention group only.
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
时间窗: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. To facilitate accuracy of the test over video, the participant will be instructed to count out loud each time he/she stands. Further, the test will also be facilitated by the Platform.
次要结局
- 4-Stage Balance Test(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- MRC Dyspnea(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- Activities-Specific Balance Confidence (ABC) Scale(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- Safety Event Count(Week 12)
- Timed Up-and-Go Test (TUG)(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- System Usability Scale (SUS)(6 weeks (primary end point))
- Three-Item Loneliness Scale(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- Montreal Cognitive Assessment (MoCA)-BLIND(Change from Baseline to week 12)
- Average Daily Step Count(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- PROMIS Scale v1.2 Global Health:(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- Clinical Frailty Scale(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)
- Patient Health Questionnaire 8 (PHQ8)(Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks)