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Clinical Trials/NCT04500366
NCT04500366
Completed
Not Applicable

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

McMaster University1 site in 1 country70 target enrollmentAugust 26, 2020
ConditionsFrailty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frailty
Sponsor
McMaster University
Enrollment
70
Locations
1
Primary Endpoint
Change in Physical Function
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 26, 2020
End Date
November 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alexandra Papaioannou

Director, GERAS Centre for Aging Research

McMaster University

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.

Outcomes

Primary Outcomes

Change in Physical Function

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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