GERAS Frailty Rehabilitation at Home During COVID-19

Study Overview
=================
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.

Official Title
-----------------
GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Behavioral: Socialization
* Behavioral: Virtual Group Exercise
* Combination Product: Nutrition Consult and Protein Supplementation
* Behavioral: Medication Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into two arms (35/arm based on sample size calculation) for 12-weeks of socialization only or multi-modal frailty rehabilitation. The socialization only arm will receive 1x/week phone calls from medical student volunteers. 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 via a videoconferencing service.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Socialization<br>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. | Behavioral: Socialization<br>* Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.<br>|
| Experimental: Multi-Modal Frailty Rehabilitation<br>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. | Behavioral: Socialization<br>* Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.<br>Behavioral: Virtual Group Exercise<br>* Participants will receive twice-weekly (one hour per class) virtual exercise via small-group physiotherapy sessions for a total of 12 weeks. All exercise sessions will occur virtually via a videoconferencing system. The classes will focus on functional movements specifically designed for seniors with frailty and mobility challenges, and will include modifications for gait aids such as canes or walkers. Class sizes will be small to allow for tailoring of exercises based on challenging, safe, progressive, evidence-based exercises. In accordance with recent guidelines to achieve 3 hours/week for fall prevention practice in older adults, participants will also be provided with tailored supplemental home exercises developed by the study physiotherapist to gain an additional 1 hour of physical activity.<br>Combination Product: Nutrition Consult and Protein Supplementation<br>* Nutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult. During the consultation, study staff will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition. Protein Supplementation: Oral nutrition supplements commercially available from Nestle will be provided unless contraindicated. The oral nutrition supplement contains 360 calories and 14 grams of protein per serving. Participants are advised to take this with a meal or within 3 hours of exercise on activity days.<br>Behavioral: Medication Review<br>* A study pharmacist will review the participant's medication list and will utilize Beers and/or START/STOPP criteria to provide recommendations to optimize/update their medications to the participant's healthcare provider. Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Function | Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance. | Baseline and 12 Weeks Post-Intervention | 
| Change in Mental Health | 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]. | Baseline and 12 Weeks Post-Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sarcopenia | 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]. | Baseline and 12 Weeks Post-Intervention | 
| Change in Frailty | Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1]. | Baseline and 12 Weeks Post-Intervention | 
| Change in Self-Efficacy | Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100]. | Baseline and 12 Weeks Post-Intervention | 
| Self-Reported Change in Function, Health and Well-Being | Assessed by the interRAI Community Rehab Assessment - Self-Report | Baseline and 12 Weeks Post-Intervention | 
| Clinician-Reported Change in Function, Health and Well-Being | Assessed by the interRAI Community Rehab Assessment - Clinician-Completed | Baseline and 12 Weeks Post-Intervention | 
| Change in Fitness | 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). | Weekly up to 12 weeks | 
| Program Satisfaction | 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. | 12 Weeks Post-Intervention | 
| Change in Health-Related Quality of Life | Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life [range 0-100]. | Baseline and 12 Weeks Post-Intervention | 
| Change in Nutrition | Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment. | Baseline and 12 Weeks Post-Intervention | 
| Change in Emergency Room Visits | Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization. | Baseline and 12 Weeks Post-Intervention | 
| Change in Hospitalizations | Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization. | Baseline and 12 Weeks Post-Intervention | 
| Change in Number of Calls to 911 | Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization. | Baseline and 12 Weeks Post-Intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Frailty, COVID-19, Exercise, Protein, Medication