GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Physical Function
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).
详细描述
During this unprecedented time of COVID-19, many healthcare professionals are concerned that vulnerable seniors who are housebound and isolated will become deconditioned resulting in functional losses in mental status, continence and ability to complete activities of daily living. Total inactivity in seniors can result in a 10-20% decrease in muscle strength per week (1 -3% per day). Loss of muscle strength may quickly convert a vulnerable older adult who was ambulatory into a bedridden state. This will affect the health of seniors and increase demand on healthcare systems. An innovative model to deliver frailty rehabilitation services remotely is urgently needed to: 1) increase access to specialized services 2) provide added supports for seniors discharged from the hospital who are in need of rehabilitation and 3) build resilience in seniors to prevent re-hospitalization or institutionalization. Therefore, to address the immediate impact of COVID-19 policies (i.e., physical distancing and reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. This proof-of-concept, randomized control trial aims to understand how to best build resilience among vulnerable seniors through at-home rehabilitation services using socialization, exercise, nutrition, and medication support.
The short-term immediate goals for this RCT are to help vulnerable seniors who are isolated because of physical distancing measures to build strength and resilience throughout the COVID-19 pandemic. The major deliverables are 1) the adaptation of an in-person program to virtual delivery 2) the piloting of a care pathway with inter-disciplinary professionals that can be expanded to reach a larger number of individuals.
The long-term goal of the study is the seamless implementation of a new model for multimodal Frailty Rehabilitation that closes the care gap in rehabilitation for frail seniors in the immediate and foreseeable future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors, the study biostatistician, the investigative team, and the steering committee will be blinded to intervention assignments. Research assistants, study intervention personnel (pharmacist, instructors) and participants will not be blinded.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling adults aged ≥ 65 years of age;
- •Score between 4-6 (inclusive) on the clinical frailty scale;
- •Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home;
- •Obtain clearance for exercise: For hospital referrals - average resting heart rate between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self- referrals: Obtain exercise clearance from their family physician prior to the first intervention session.
排除标准
- •Unable to speak or understand English and has no caregiver for translation;
- •Significant cognitive impairment where they may have difficulty following two-step commands;
- •Receiving palliative/end of life care;
- •Unstable angina or unstable heart failure;
- •Travel plans that would result in missing greater than 20% of the trial's 12-week duration;
- •Currently attending a group exercise program.
结局指标
主要结局
Change in Physical Function
时间窗: Baseline and 12 Weeks Post-Intervention
Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
Change in Mental Health
时间窗: Baseline and 12 Weeks Post-Intervention
Assessed by the Depression Anxiety Stress Scale (DASS-21). Higher scores indicate greater risk of depression, anxiety and stress \[depression, anxiety, stress subscores range 0-21\].
次要结局
- Change in Sarcopenia(Baseline and 12 Weeks Post-Intervention)
- Change in Frailty(Baseline and 12 Weeks Post-Intervention)
- Self-Reported Change in Function, Health and Well-Being(Baseline and 12 Weeks Post-Intervention)
- Change in Number of Calls to 911(Baseline and 12 Weeks Post-Intervention)
- Change in Self-Efficacy(Baseline and 12 Weeks Post-Intervention)
- Clinician-Reported Change in Function, Health and Well-Being(Baseline and 12 Weeks Post-Intervention)
- Change in Fitness(Weekly up to 12 weeks)
- Change in Health-Related Quality of Life(Baseline and 12 Weeks Post-Intervention)
- Program Satisfaction(12 Weeks Post-Intervention)
- Change in Nutrition(Baseline and 12 Weeks Post-Intervention)
- Change in Emergency Room Visits(Baseline and 12 Weeks Post-Intervention)
- Change in Hospitalizations(Baseline and 12 Weeks Post-Intervention)
研究者
Alexandra Papaioannou
Director, GERAS Centre for Aging Research
McMaster University