<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500366</url>
  </required_header>
  <id_info>
    <org_study_id>11408</org_study_id>
    <nct_id>NCT04500366</nct_id>
  </id_info>
  <brief_title>GERAS Frailty Rehabilitation at Home During COVID-19</brief_title>
  <official_title>GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a&#xD;
      toll on physical and mental health. Many healthcare professionals are concerned vulnerable&#xD;
      seniors may become deconditioned, which substantially increases risk of health complications&#xD;
      and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e.,&#xD;
      physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be&#xD;
      adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim&#xD;
      is to understand how to best build resilience among vulnerable seniors in the community&#xD;
      through at-home rehabilitation services (socialization, exercise, nutrition, and medication&#xD;
      support).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During this unprecedented time of COVID-19, many healthcare professionals are concerned that&#xD;
      vulnerable seniors who are housebound and isolated will become deconditioned resulting in&#xD;
      functional losses in mental status, continence and ability to complete activities of daily&#xD;
      living. Total inactivity in seniors can result in a 10-20% decrease in muscle strength per&#xD;
      week (1 -3% per day). Loss of muscle strength may quickly convert a vulnerable older adult&#xD;
      who was ambulatory into a bedridden state. This will affect the health of seniors and&#xD;
      increase demand on healthcare systems. An innovative model to deliver frailty rehabilitation&#xD;
      services remotely is urgently needed to: 1) increase access to specialized services 2)&#xD;
      provide added supports for seniors discharged from the hospital who are in need of&#xD;
      rehabilitation and 3) build resilience in seniors to prevent re-hospitalization or&#xD;
      institutionalization. Therefore, to address the immediate impact of COVID-19 policies (i.e.,&#xD;
      physical distancing and reduced access to care), the GERAS Frailty Rehabilitation model will&#xD;
      be adapted to be delivered remotely in the homes of vulnerable seniors. This&#xD;
      proof-of-concept, randomized control trial aims to understand how to best build resilience&#xD;
      among vulnerable seniors through at-home rehabilitation services using socialization,&#xD;
      exercise, nutrition, and medication support.&#xD;
&#xD;
      The short-term immediate goals for this RCT are to help vulnerable seniors who are isolated&#xD;
      because of physical distancing measures to build strength and resilience throughout the&#xD;
      COVID-19 pandemic. The major deliverables are 1) the adaptation of an in-person program to&#xD;
      virtual delivery 2) the piloting of a care pathway with inter-disciplinary professionals that&#xD;
      can be expanded to reach a larger number of individuals.&#xD;
&#xD;
      The long-term goal of the study is the seamless implementation of a new model for multimodal&#xD;
      Frailty Rehabilitation that closes the care gap in rehabilitation for frail seniors in the&#xD;
      immediate and foreseeable future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2020</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Physical Function</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Mental Health</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <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].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Sarcopenia</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <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].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Frailty</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Efficacy</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Change in Function, Health and Well-Being</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the interRAI Community Rehab Assessment - Self-Report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician-Reported Change in Function, Health and Well-Being</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the interRAI Community Rehab Assessment - Clinician-Completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fitness</measure>
    <time_frame>Weekly up to 12 weeks</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Program Satisfaction</measure>
    <time_frame>12 Weeks Post-Intervention</time_frame>
    <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 &quot;Strongly Disagree&quot; to &quot;Strongly Agree&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health-Related Quality of Life</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life [range 0-100].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nutrition</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Emergency Room Visits</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hospitalizations</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Calls to 911</measure>
    <time_frame>Baseline and 12 Weeks Post-Intervention</time_frame>
    <description>Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility Outcome #1 - Reach of intervention</measure>
    <time_frame>12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the number of individuals who participated. Target reach is 70 participants.</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility Outcome #2 - Adoption of the Intervention</measure>
    <time_frame>12 Weeks Post-Intervention</time_frame>
    <description>Assessed by number of referral sites. Target is 5 referral sites.</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility Outcome #3 - Implementation of the Intervention</measure>
    <time_frame>12 Weeks Post-Intervention</time_frame>
    <description>Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility Outcome #4 - Maintenance of the Intervention</measure>
    <time_frame>12 Weeks Post-Intervention</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Socialization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multi-Modal Frailty Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Socialization</intervention_name>
    <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.</description>
    <arm_group_label>Multi-Modal Frailty Rehabilitation</arm_group_label>
    <arm_group_label>Socialization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Group Exercise</intervention_name>
    <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.</description>
    <arm_group_label>Multi-Modal Frailty Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Nutrition Consult and Protein Supplementation</intervention_name>
    <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.&#xD;
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.</description>
    <arm_group_label>Multi-Modal Frailty Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medication Review</intervention_name>
    <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.</description>
    <arm_group_label>Multi-Modal Frailty Rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Community-dwelling adults aged ≥ 65 years of age;&#xD;
&#xD;
          -  Score between 4-6 (inclusive) on the clinical frailty scale;&#xD;
&#xD;
          -  Able to ambulate independently with or without a walking aid; OR with caregiver&#xD;
             supervision at home;&#xD;
&#xD;
          -  Obtain clearance for exercise: For hospital referrals - average resting heart rate&#xD;
             between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per&#xD;
             Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self-&#xD;
             referrals: Obtain exercise clearance from their family physician prior to the first&#xD;
             intervention session.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak or understand English and has no caregiver for translation;&#xD;
&#xD;
          -  Significant cognitive impairment where they may have difficulty following two-step&#xD;
             commands;&#xD;
&#xD;
          -  Receiving palliative/end of life care;&#xD;
&#xD;
          -  Unstable angina or unstable heart failure;&#xD;
&#xD;
          -  Travel plans that would result in missing greater than 20% of the trial's 12-week&#xD;
             duration;&#xD;
&#xD;
          -  Currently attending a group exercise program.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra Papaioannou, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientific Director, GERAS Centre for Aging Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster University - Hamilton Health Sciences (St. Peter's Site)</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8M1W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 4, 2022</last_update_submitted>
  <last_update_submitted_qc>March 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Alexandra Papaioannou</investigator_full_name>
    <investigator_title>Director, GERAS Centre for Aging Research</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Frailty</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Exercise</keyword>
  <keyword>Protein</keyword>
  <keyword>Medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500366
org study id: 11408
nct id: NCT04500366
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
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. 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
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.
measure: Change in Physical Function
time frame: Baseline and 12 Weeks Post-Intervention
description: Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
measure: Change in Mental Health
time frame: Baseline and 12 Weeks Post-Intervention
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].
measure: Change in Sarcopenia
time frame: Baseline and 12 Weeks Post-Intervention
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].
measure: Change in Frailty
time frame: Baseline and 12 Weeks Post-Intervention
description: Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
measure: Change in Self-Efficacy
time frame: Baseline and 12 Weeks Post-Intervention
description: Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100].
measure: Self-Reported Change in Function, Health and Well-Being
time frame: Baseline and 12 Weeks Post-Intervention
description: Assessed by the interRAI Community Rehab Assessment - Self-Report
measure: Clinician-Reported Change in Function, Health and Well-Being
time frame: Baseline and 12 Weeks Post-Intervention
description: Assessed by the interRAI Community Rehab Assessment - Clinician-Completed
measure: Change in Fitness
time frame: Weekly up to 12 weeks
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).
measure: Program Satisfaction
time frame: 12 Weeks Post-Intervention
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".
measure: Change in Health-Related Quality of Life
time frame: Baseline and 12 Weeks Post-Intervention
description: Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life [range 0-100].
measure: Change in Nutrition
time frame: Baseline and 12 Weeks Post-Intervention
description: Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.
measure: Change in Emergency Room Visits
time frame: Baseline and 12 Weeks Post-Intervention
description: Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
measure: Change in Hospitalizations
time frame: Baseline and 12 Weeks Post-Intervention
description: Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
measure: Change in Number of Calls to 911
time frame: Baseline and 12 Weeks Post-Intervention
description: Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.
measure: Feasibility Outcome #1 - Reach of intervention
time frame: 12 Weeks Post-Intervention
description: Assessed by the number of individuals who participated. Target reach is 70 participants.
measure: Feasibility Outcome #2 - Adoption of the Intervention
time frame: 12 Weeks Post-Intervention
description: Assessed by number of referral sites. Target is 5 referral sites.
measure: Feasibility Outcome #3 - Implementation of the Intervention
time frame: 12 Weeks Post-Intervention
description: Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.
measure: Feasibility Outcome #4 - Maintenance of the Intervention
time frame: 12 Weeks Post-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.
arm group label: Socialization
arm group type: Active Comparator
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 group label: Multi-Modal Frailty Rehabilitation
arm group type: Experimental
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: Socialization
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.
arm group label: Multi-Modal Frailty Rehabilitation
arm group label: Socialization
intervention type: Behavioral
intervention name: Virtual Group Exercise
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.
arm group label: Multi-Modal Frailty Rehabilitation
intervention type: Combination Product
intervention name: Nutrition Consult and Protein Supplementation
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.
arm group label: Multi-Modal Frailty Rehabilitation
intervention type: Behavioral
intervention name: Medication Review
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.
arm group label: Multi-Modal Frailty Rehabilitation
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandra Papaioannou, MD, MSc
role: Principal Investigator
affiliation: Scientific Director, GERAS Centre for Aging Research
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Alexandra Papaioannou
investigator title: Director, GERAS Centre for Aging Research
mesh term: COVID-19
mesh term: Frailty