GERAS Frailty Rehabilitation at Home During COVID-19
- Conditions
- Frailty
- Interventions
- Behavioral: SocializationBehavioral: Virtual Group ExerciseCombination Product: Nutrition Consult and Protein SupplementationBehavioral: Medication Review
- Registration Number
- NCT04500366
- Lead Sponsor
- McMaster University
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-Modal Frailty Rehabilitation Virtual Group Exercise Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system. Multi-Modal Frailty Rehabilitation Nutrition Consult and Protein Supplementation Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system. Socialization Socialization Participants randomized to the socialization arm will receive once-weekly phone calls from medical student volunteers for a total of 12-weeks (n=35). This program pairs health professional student volunteers with older adults in the community to provide social comfort while heightened physical distancing measures are in place during the current COVID-19 pandemic. Attendance and duration of the phone calls will be logged. Multi-Modal Frailty Rehabilitation Socialization Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system. Multi-Modal Frailty Rehabilitation Medication Review Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system.
- Primary Outcome Measures
Name Time Method Change in Physical Function 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 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 \[depression, anxiety, stress subscores range 0-21\].
- Secondary Outcome Measures
Name Time Method Change in Sarcopenia Baseline and 12 Weeks Post-Intervention Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls. Higher scores indicate greater level of sarcopenia \[range 0-10\].
Change in Frailty Baseline and 12 Weeks Post-Intervention Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty \[range 0-1\].
Self-Reported Change in Function, Health and Well-Being Baseline and 12 Weeks Post-Intervention Assessed by the interRAI Community Rehab Assessment - Self-Report
Change in Number of Calls to 911 Baseline and 12 Weeks Post-Intervention Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.
Change in Self-Efficacy Baseline and 12 Weeks Post-Intervention Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence \[range 0-100\].
Clinician-Reported Change in Function, Health and Well-Being Baseline and 12 Weeks Post-Intervention Assessed by the interRAI Community Rehab Assessment - Clinician-Completed
Change in Fitness Weekly up to 12 weeks Assessed by the Borg Rate of Perceived Exertion after exercise. Higher scores indicate greater level of exertion \[range 6-20\]. Also assessed using accelerometers (heart rate, sedentary time, physical activity time, energy expenditure).
Change in Health-Related Quality of Life Baseline and 12 Weeks Post-Intervention Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life \[range 0-100\].
Program Satisfaction 12 Weeks Post-Intervention Assessed using a program questionnaire in accordance with the Kirkpatrick 5-Level Evaluation Model. Scores will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree".
Change in Nutrition Baseline and 12 Weeks Post-Intervention Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.
Change in Emergency Room Visits Baseline and 12 Weeks Post-Intervention Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Change in Hospitalizations Baseline and 12 Weeks Post-Intervention Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Trial Locations
- Locations (1)
McMaster University - Hamilton Health Sciences (St. Peter's Site)
🇨🇦Hamilton, Ontario, Canada