Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

The PREPARE for COVID Trial

15. mai 2020 oppdatert av: Ottawa Hospital Research Institute

PRomoting Exercise During the Pandemic to Increase Activity and Reduce Effects of Social Isolation for COVID: The PREPARE for COVID Trial

This is a randomized trial of home-based exercises versus control for older adults during the COVID-19 pandemic. The hypothesis is that participation in a home-based program will reduce the risk of adverse effects of physical distancing by decreasing patient-reported disability, improving mental health and avoiding hospitalization or institutionalization for vulnerable older people

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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)

Studietype

Intervensjonell

Registrering (Forventet)

372

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Ivy Salter
  • Telefonnummer: 13790 613-798-5555
  • E-post: isalter@ohri.ca

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: The PREPARE program

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.
Ingen inngripen: Kontrollgruppe
Kontrollgruppen vil motta en brosjyre fra Verdens helseorganisasjon for fysisk aktivitet for personer over eller lik 65 år gammel, samt en veiledning til sunn mat for eldre voksne.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient-reported disability 90 days after enrollment
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mental Health
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Health System - Re-admission
Tidsramme: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Health System - Transfer to Long-Term Care
Tidsramme: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
COVID-19 test results
Tidsramme: Monthly for 12 months following enrollment.
Monthly for 12 months following enrollment.
Safety [Adverse Events]
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ottawa Hospital Research Institute

Etterforskere

  • Hovedetterforsker: Daniel I McIsaac, MD, The Ottawa Hospital Research Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

15. juni 2020

Primær fullføring (Forventet)

15. desember 2020

Studiet fullført (Forventet)

15. september 2021

Datoer for studieregistrering

Først innsendt

15. mai 2020

Først innsendt som oppfylte QC-kriteriene

15. mai 2020

Først lagt ut (Faktiske)

18. mai 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Sosial isolering

Kliniske studier på The PREPARE program

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in United Kingdom

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere