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GERAS Frailty Rehabilitation at Home During COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500366
Recruitment Status : Not yet recruiting
First Posted : August 5, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Alexandra Papaioannou, 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).

Condition or disease Intervention/treatment Phase
Frailty Behavioral: Socialization Behavioral: Virtual Group Exercise Combination Product: Nutrition Consult and Protein Supplementation Behavioral: Medication Review Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 via the McMaster Student-Senior Isolation Prevention Partnership (SSIPP). Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization (SSIPP), 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual dietician consult), and medication support (virtual pharmacist consult) all via a videoconferencing service.
Masking: Double (Investigator, Outcomes 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.
Primary Purpose: Prevention
Official Title: GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Socialization
Participants randomized to the socialization arm will receive once-weekly phone calls from medical student volunteers via the McMaster Student-Senior Isolation Prevention Partnership (SSIPP) for a total of 12-weeks (n=35). The 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
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.

Experimental: Multi-Modal Frailty Rehabilitation
Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization via SSIPP, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual dietician consult), and medication support (virtual pharmacist consult) all through a videoconferencing system.
Behavioral: Socialization
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.

Behavioral: Virtual Group Exercise
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.

Combination Product: Nutrition Consult and Protein Supplementation

Nutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult with the study dietitian. During the consultation, the dietitian will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition.

Protein Supplementation: As piloted in our Fit Joints Study, the protein supplement (each serving) contains 350 kcal, 20-gram protein, 1.5 g β-Hydroxy β-Methylbutyrate (HMB), and participants are advised to take this with a meal or within 3 hours of exercise on activity days.


Behavioral: Medication Review
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 Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change in Sarcopenia [ Time Frame: 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].

  2. Change in Frailty [ Time Frame: Baseline and 12 Weeks Post-Intervention ]
    Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].

  3. Change in Self-Efficacy [ Time Frame: 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].

  4. Self-Reported Change in Function, Health and Well-Being [ Time Frame: Baseline and 12 Weeks Post-Intervention ]
    Assessed by the interRAI Community Rehab Assessment - Self-Report

  5. Clinician-Reported Change in Function, Health and Well-Being [ Time Frame: Baseline and 12 Weeks Post-Intervention ]
    Assessed by the interRAI Community Rehab Assessment - Clinician-Completed

  6. Change in Fitness [ Time Frame: 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].

  7. Program Satisfaction [ Time Frame: 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".

  8. Change in Emergency Room Visits [ Time Frame: Baseline and 12 Weeks Post-Intervention ]
    Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.

  9. Change in Hospitalizations [ Time Frame: Baseline and 12 Weeks Post-Intervention ]
    Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.

  10. Change in Number of Calls to 911 [ Time Frame: Baseline and 12 Weeks Post-Intervention ]
    Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.


Other Outcome Measures:
  1. Feasibility Outcome #1 - Reach of intervention [ Time Frame: 12 Weeks Post-Intervention ]
    Assessed by the number of individuals who participated. Target reach is 70 participants.

  2. Feasibility Outcome #2 - Adoption of the Intervention [ Time Frame: 12 Weeks Post-Intervention ]
    Assessed by number of referral sites. Target is 5 referral sites.

  3. Feasibility Outcome #3 - Implementation of the Intervention [ Time Frame: 12 Weeks Post-Intervention ]
    Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.

  4. Feasibility Outcome #4 - Maintenance of the Intervention [ Time Frame: 12 Weeks Post-Intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Community-dwelling adults aged ≥ 65 years of age;
  • Has access, or has a caregiver who has access to a device at home that can support a videoconferencing service (e.g. Zoom, FaceTime, Skype);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500366


Contacts
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Contact: Sherri Smith 905-521-2100 ext 77715 smithsher@hhsc.ca

Locations
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Canada, Ontario
McMaster University - St. Peter's Hospital
Hamilton, Ontario, Canada, L8M1W9
Contact: Sherri Smith    905-521-2100 ext 77715    smithsher@hhsc.ca   
Principal Investigator: Alexandra Papaioannou, MD, MSc         
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Alexandra Papaioannou, MD, MSc Scientific Director, GERAS Centre for Aging Research
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Responsible Party: Alexandra Papaioannou, Director, GERAS Centre for Aging Research, McMaster University
ClinicalTrials.gov Identifier: NCT04500366    
Other Study ID Numbers: 11408
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandra Papaioannou, McMaster University:
Rehabilitation
Frailty
COVID-19
Exercise
Protein
Medication
Additional relevant MeSH terms:
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Frailty
Pathologic Processes