- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392115
The PREPARE for COVID Trial
PRomoting Exercise During the Pandemic to Increase Activity and Reduce Effects of Social Isolation for COVID: The PREPARE for COVID Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:More than 6.5 million Canadians are > 65 years of age. Over half of older Canadians live with multiple comorbidities, leaving them at high risk of adverse outcomes of COVID-19. Social isolation and physical distancing orders are especially important to protect the health of this high-risk population. Vulnerable older Canadians are also at high risk of physical and mental health deterioration caused by the physical distancing meant to protect them from COVID-19. Effective management of the COVID-19 pandemic and its consequences will require evidence-based strategies to support isolated vulnerable older Canadians. Exercise interventions can reduce the adverse health effects of social isolation and demonstrate larger effect sizes in older people with comorbidities. However, no exercise interventions have been tested in an acute isolation scenario such as the COVID-19 pandemic, which also requires that exercise interventions be home-based and remotely supported, presenting unique challenges to participation and adherence.
Our team is uniquely positioned re-orient proven and robust programming, supported by a national network of investigators and existing infrastructure. We can immediately launch a large-scale trial to test the effectiveness of a remotely supported home exercise program (designed in partnership with vulnerable older Canadians) to mitigate the negative consequences of physical distancing to keep older Canadians healthy and safe from COVID-19. We hypothesize that participation in the PREPARE program will decrease the individual, health system and population health impacts of COVID19 induced physical distancing and social isolation.
Research aims:Estimate the effectiveness of a remotely supported, home-based multimodal exercise program for older people with multiple comorbidities to improve our primary outcome: patient-reported disability 90-days after enrollment; secondary outcomes: patient-centered (depression, anxiety, quality of life, frailty, survival, 1-year disability scores, COVID19 severity) and system-relevant (admissions, emergency visits, institutionalization, costs, cost-effectiveness).
Methods: Design, setting and participants: Parallel-arm multicenter randomized controlled trial at 3 Canadian hospitals. People >65 years old recently discharged home with >2 comorbidities will be included. Intervention: Three month supported home-based exercise program with demonstrated efficacy, feasibility and acceptability for vulnerable older people.
Outcomes and sample size: We will have 90% power to detect a clinically important difference of in our primary outcome (validated WHODAS tool, 90-days post-enrollment) with 372 participants (186/arm)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ivy Salter
- Phone Number: 13790 613-798-5555
- Email: isalter@ohri.ca
Study Contact Backup
- Name: Emily Hladkowicz
- Phone Number: 613-292-6714
- Email: emhladkowicz@toh.on.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65 years of age or older
- 2 or more co-morbidities
- recent discharge from hospital
Exclusion Criteria:
- Inability to communicate in English or in French
- Unreachable by telephone
- Unstable cardiovascular or valvular disease
- Discharged to Long-Term Care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Group
The home-based exercise program called the PREPARE program. Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility. |
A home-based exercise program guided by paper materials, weekly phone calls, and a DVD. Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility. |
No Intervention: Control Group
The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-reported disability 90 days after enrollment
Time Frame: Assessing change in score from baseline data collection to 90 days from enrollment
|
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used .
It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society.
Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.
|
Assessing change in score from baseline data collection to 90 days from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health
Time Frame: Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
|
The Patient Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) are validated tools for diagnosing anxiety and depression.
|
Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
|
Function
Time Frame: Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
|
Step count using pedometer
|
Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
|
Health-related quality of life
Time Frame: Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
|
The EQ-5D-5L is a validated instrument with Canadian valuation statistics and national use, which informs incremental cost per quality-adjusted life year gained.
|
Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
|
Frailty
Time Frame: Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
|
The Clinical Frailty Scale (CFS) provides a global assessment of frailty.
|
Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
|
All-cause mortality.
Time Frame: From enrollment to 12 months after enrollment.
|
All deaths and death dates will be identified via chart review or telephone call.
|
From enrollment to 12 months after enrollment.
|
Health System - Emergency Department Visits
Time Frame: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
Health System - Re-admission
Time Frame: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
Health System - Transfer to Long-Term Care
Time Frame: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
COVID-19 test results
Time Frame: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
Safety [Adverse Events]
Time Frame: Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.
|
Falls, cardiac or respiratory complications and unplanned healthcare encounters will be collected during the exercise treatment period for the exercise group.
For the control group, participants will be asked if they experienced any falls since the time of enrollment up until the day before surgery.
Unplanned healthcare encounters will also be collected during the time of enrollment to the final day of the exercise intervention for the intervention group through chart review.
|
Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel I McIsaac, MD, The Ottawa Hospital Research Institute
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Social Isolation
-
University of British ColumbiaVancouver Foundation; Inner-City Women's Initiatives SocietyEnrolling by invitationLoneliness | Social Support | Social IsolationCanada
-
University of California, Los AngelesNot yet recruitingSocial Isolation
-
Maimónides Biomedical Research Institute of CórdobaCompleted
-
McMaster UniversitySocial Sciences and Humanities Research Council of CanadaCompletedSocial IsolationCanada
-
Centre Hospitalier Universitaire de NiceNot yet recruiting
-
University of PadovaActive, not recruiting
-
Dartmouth-Hitchcock Medical CenterUniversity of Texas at AustinCompleted
-
Bright Vision HospitalSengkang Community Hospital; Outram Community HospitalNot yet recruiting
-
Boston Medical CenterCompleted
Clinical Trials on The PREPARE program
-
NYU Langone HealthCompleted
-
Brescia University CollegeUnknown
-
University Hospitals, LeicesterDiabetes UKCompletedPrediabetic StateUnited Kingdom
-
University of California, San FranciscoNational Institute on Aging (NIA)CompletedChronic DiseaseUnited States
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteCompletedChronic DiseaseUnited States
-
Womack Army Medical CenterUnited States Department of Defense; Walter Reed National Military Medical...RecruitingMusculoskeletal InjuriesUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; University of California, IrvineActive, not recruitingAdvanced Cancer | Advance Care Planning | Advance DirectivesUnited States
-
University of Massachusetts, AmherstUniversity of GhanaEnrolling by invitationHealth Literacy | Dietary Diversity | Infant Feeding PracticesGhana
-
VA Office of Research and DevelopmentCompleted
-
University of PittsburghRobert Wood Johnson Foundation; Donaghue Medical Research FoundationTerminated