Clinical trial NCT04500366: GERAS Frailty Rehabilitation at Home During COVID-19
Official title: GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: Rehabilitation
Frailty
COVID-19
Exercise
Protein
Medication
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Physical Function
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Mental Health
timeFrame: Baseline and 12 Weeks Post-Intervention
Secondary outcomes:
measure: Change in Sarcopenia
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Frailty
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Self-Efficacy
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Self-Reported Change in Function, Health and Well-Being
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Clinician-Reported Change in Function, Health and Well-Being
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Fitness
timeFrame: Weekly up to 12 weeks
measure: Program Satisfaction
timeFrame: 12 Weeks Post-Intervention
measure: Change in Health-Related Quality of Life
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Nutrition
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Emergency Room Visits
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Hospitalizations
timeFrame: Baseline and 12 Weeks Post-Intervention
measure: Change in Number of Calls to 911
timeFrame: Baseline and 12 Weeks Post-Intervention
Other outcomes:
measure: Feasibility Outcome #1 - Reach of intervention
timeFrame: 12 Weeks Post-Intervention
measure: Feasibility Outcome #2 - Adoption of the Intervention
timeFrame: 12 Weeks Post-Intervention
measure: Feasibility Outcome #3 - Implementation of the Intervention
timeFrame: 12 Weeks Post-Intervention
measure: Feasibility Outcome #4 - Maintenance of the Intervention
timeFrame: 12 Weeks Post-Intervention
Locations:
city: Hamilton
country: Canada
facility: McMaster University - Hamilton Health Sciences (St. Peter's Site)
state: Ontario
Study officials:
affiliation: Scientific Director, GERAS Centre for Aging Research
name: Alexandra Papaioannou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: