GERAS Frailty Rehabilitation at Home During COVID-19

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500366
• Other study ID #: 11408
• Status: Completed
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: March 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Frailty

Intervention

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.
• 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. 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.

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.

Locations

Country	Name	City	State
Canada	McMaster University - Hamilton Health Sciences (St. Peter's Site)	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility Outcome #1 - Reach of intervention	Assessed by the number of individuals who participated. Target reach is 70 participants.	12 Weeks Post-Intervention
Other	Feasibility Outcome #2 - Adoption of the Intervention	Assessed by number of referral sites. Target is 5 referral sites.	12 Weeks Post-Intervention
Other	Feasibility Outcome #3 - Implementation of the Intervention	Assessed by the number of individuals who completed the intervention. Higher number of individuals completing the study indicates greater success in implementation.	12 Weeks Post-Intervention
Other	Feasibility Outcome #4 - Maintenance of the 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.	12 Weeks Post-Intervention
Primary	Change in Physical Function	Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.	Baseline and 12 Weeks Post-Intervention
Primary	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].	Baseline and 12 Weeks Post-Intervention
Secondary	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].	Baseline and 12 Weeks Post-Intervention
Secondary	Change in Frailty	Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].	Baseline and 12 Weeks Post-Intervention
Secondary	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].	Baseline and 12 Weeks Post-Intervention
Secondary	Self-Reported Change in Function, Health and Well-Being	Assessed by the interRAI Community Rehab Assessment - Self-Report	Baseline and 12 Weeks Post-Intervention
Secondary	Clinician-Reported Change in Function, Health and Well-Being	Assessed by the interRAI Community Rehab Assessment - Clinician-Completed	Baseline and 12 Weeks Post-Intervention
Secondary	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).	Weekly up to 12 weeks
Secondary	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".	12 Weeks Post-Intervention
Secondary	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].	Baseline and 12 Weeks Post-Intervention
Secondary	Change in Nutrition	Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.	Baseline and 12 Weeks Post-Intervention
Secondary	Change in Emergency Room Visits	Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.	Baseline and 12 Weeks Post-Intervention
Secondary	Change in Hospitalizations	Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.	Baseline and 12 Weeks Post-Intervention
Secondary	Change in Number of Calls to 911	Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.	Baseline and 12 Weeks Post-Intervention