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GERAS Frailty Rehabilitation at Home During COVID-19

Primary Purpose

Frailty

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Socialization
Virtual Group Exercise
Nutrition Consult and Protein Supplementation
Medication Review
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring Rehabilitation, Frailty, COVID-19, Exercise, Protein, Medication

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McMaster University - Hamilton Health Sciences (St. Peter's Site)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Socialization

Multi-Modal Frailty Rehabilitation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change in Physical Function
Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
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].

Secondary Outcome Measures

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].
Change in Frailty
Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
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].
Self-Reported Change in Function, Health and Well-Being
Assessed by the interRAI Community Rehab Assessment - Self-Report
Clinician-Reported Change in Function, Health and Well-Being
Assessed by the interRAI Community Rehab Assessment - Clinician-Completed
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).
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".
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].
Change in Nutrition
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
Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Change in Hospitalizations
Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Change in Number of Calls to 911
Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.

Full Information

First Posted
July 31, 2020
Last Updated
March 4, 2022
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04500366
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Rehabilitation, Frailty, COVID-19, Exercise, Protein, Medication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Socialization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multi-Modal Frailty Rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Socialization
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Group Exercise
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Nutrition Consult and Protein Supplementation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication Review
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Physical Function
Description
Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Mental Health
Description
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].
Time Frame
Baseline and 12 Weeks Post-Intervention
Secondary Outcome Measure Information:
Title
Change in Sarcopenia
Description
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].
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Frailty
Description
Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Self-Efficacy
Description
Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100].
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Self-Reported Change in Function, Health and Well-Being
Description
Assessed by the interRAI Community Rehab Assessment - Self-Report
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Clinician-Reported Change in Function, Health and Well-Being
Description
Assessed by the interRAI Community Rehab Assessment - Clinician-Completed
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Fitness
Description
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).
Time Frame
Weekly up to 12 weeks
Title
Program Satisfaction
Description
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".
Time Frame
12 Weeks Post-Intervention
Title
Change in Health-Related Quality of Life
Description
Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life [range 0-100].
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Nutrition
Description
Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Emergency Room Visits
Description
Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Hospitalizations
Description
Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Time Frame
Baseline and 12 Weeks Post-Intervention
Title
Change in Number of Calls to 911
Description
Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.
Time Frame
Baseline and 12 Weeks Post-Intervention
Other Pre-specified Outcome Measures:
Title
Feasibility Outcome #1 - Reach of intervention
Description
Assessed by the number of individuals who participated. Target reach is 70 participants.
Time Frame
12 Weeks Post-Intervention
Title
Feasibility Outcome #2 - Adoption of the Intervention
Description
Assessed by number of referral sites. Target is 5 referral sites.
Time Frame
12 Weeks Post-Intervention
Title
Feasibility Outcome #3 - Implementation of the Intervention
Description
Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.
Time Frame
12 Weeks Post-Intervention
Title
Feasibility Outcome #4 - Maintenance of the Intervention
Description
Assessed by the number of referral sites continuing with a second cohort. Greater number of referral sites continuing with a second cohort indicates greater maintenance.
Time Frame
12 Weeks Post-Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
Organizational Affiliation
Scientific Director, GERAS Centre for Aging Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University - Hamilton Health Sciences (St. Peter's Site)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M1W9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

GERAS Frailty Rehabilitation at Home During COVID-19

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