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
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
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)
Tanulmány típusa
Beiratkozás (Várható)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egészségügyi szolgáltatások kutatása
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: 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. |
|
Nincs beavatkozás: Ellenőrző csoport
A kontrollcsoport megkapja az Egészségügyi Világszervezet ajánlásait a 65 év felettiek fizikai aktivitására vonatkozóan, valamint egy útmutatót az egészséges táplálkozáshoz idősebb felnőttek számára.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Patient-reported disability 90 days after enrollment
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Mental Health
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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.
Időkeret: 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
Időkeret: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
|
Health System - Re-admission
Időkeret: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
|
Health System - Transfer to Long-Term Care
Időkeret: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
|
COVID-19 test results
Időkeret: Monthly for 12 months following enrollment.
|
Monthly for 12 months following enrollment.
|
|
|
Safety [Adverse Events]
Időkeret: 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.
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Daniel I McIsaac, MD, The Ottawa Hospital Research Institute
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Várható)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .