Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors

NCT ID: NCT03991598

Last Updated: 2019-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-07-31

Brief Summary

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About 18% of independent people over 65 who are evaluated in Emergency Departments for minor injuries (fractures, sprains) present some mobility decline up to 3 to 6 months postinjury. People at risk of decline are prefrail or frail; this condition could be explained by muscle proprieties loss. Exercise is a proven method that can help limit frailty and allow to restore mobility.

The aim of our study is to evaluate whether a suitable exercise program of one hour, twice a week for 12 weeks will limit functional losses \& fragility in injured older adults after their emergency department visit.

Detailed Description

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Yearly, around 400 000 Canadian community-dwelling seniors sustain injuries that are not life threatening but limit their mobility and normal activities. Up to 65 % of these seniors seek care in Emergency Departments (EDs) and 2/3 are discharged from EDs with varying degrees of minor injuries. Since 2010 and using multicenter large Canadian cohorts (n=3000), our CIHR CETI\* emerging team has shown that minor injuries trigger a downward spiral of mobility decline in 16% of seniors who are still independent at the time of injury, unmasking early impairments and a prefrail or frail status. As there are no ED management guidelines designed to prevent these prefrail (35%) and frail (13%) injured seniors from losing their mobility and function, they do deteriorate within 6 months post-ED discharge. This is unfortunate because there is compelling evidence of the effectiveness of community and home-based mobility interventions showing that simple, targeted interventions can prevent frailty and functional limitations.

In that context, identification of seniors at risk in EDs is crucial to implement effective interventions. The CETI has validated a simple Clinical Decision Rule (CETI-CDR) that screens and orients seniors at high, moderate and low risk of functional decline to appropriate post-ED follow-ups. The latter include effective community-based mobility interventions available across all Canadian communities. An ongoing pilot study (n=120) in two EDs is showing the feasibility and effectiveness (functional decline prevention) of interventions and patient satisfaction. The investigators thus propose to implement the CEDeComS intervention, which involves the CETI-CDR combined with rapid linkage to community mobility programs directly from EDs.

The Main Objectives of this study are to 1) evaluate the effectiveness of the CEDeComS compared to usual care, on improving seniors' health outcomes, 2) determine the cost-effectiveness of the intervention.

Conditions

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Elderly Functional Status

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a step-wedge clinical trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention

EDs 1 to 7 will then be randomly phased-in INT every 3 months.

Group Type EXPERIMENTAL

Exercise program

Intervention Type OTHER

Exercise program in communities / Exercise program at home

control

During the first 6 months and throughout CTRL time

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise program

Exercise program in communities / Exercise program at home

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Consultation at Emergency Department (ED) for an injury
* Injury happened in the 14 days prior to ED visit
* 65 years old and over
* Discharge from ED within 48 hours
* Independant in basic Activities of Daily Living (ADL)

Exclusion Criteria

* Hospitalization related to the trauma
* Major surgery related to the trauma
* Not independant in ADL
* Living in a long-term care home
* Important cognitive impairment
* Not speaking French or English
* Unable to consent
* No trauma
Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université du Québec a Montréal

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role collaborator

Alberta Health Services, Calgary

OTHER

Sponsor Role collaborator

Sunnybrook Research Institute

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role collaborator

University of Ottawa

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Marie-Josée Sirois

Ph.D Independent Researcher - Mid Career Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcel ME Emond, Md, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du CHU de Québec

Locations

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Alberta Health Services

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

Alberta Health Services

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

Sunnybrook Health Science Center

Toronto, Ontario, Canada

Site Status ACTIVE_NOT_RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontaro, Canada

Site Status NOT_YET_RECRUITING

Hôpital Sacré-Coeur

Montreal, Quebec, Canada

Site Status RECRUITING

CHU-Québec

Québec, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Marie-Josée MJ Sirois, Ph.D

Role: CONTACT

418-649-0252 ext. 66244

Sandrine SH Hegg, Ph.D

Role: CONTACT

418-649-0252 ext. 64293

Facility Contacts

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Eddy lang, MD, MSc

Role: primary

Tristan holotnak, MSc

Role: backup

Brian Rowe, MD. MSc

Role: primary

natalie runham, MSc

Role: backup

Jeff Perry, MD, MSc

Role: primary

cathy Clement, MSc

Role: backup

Raoul daoust, MD, MSc

Role: primary

514-338-2222 ext. 3318

chantal lanthier, RN

Role: backup

514-338-2222 ext. 3318

marie-josée sirois, PhD

Role: primary

418-649-0252 ext. 64293

sandrine hegg, Phd

Role: backup

418-649-0252 ext. 64293

References

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Sirois MJ, Blais J, Aubertin-Leheudre M, Carmichael PH, Fruteau de Laclos L, Desjardins A, Daoust R, Eagles D, Lee J, Perry JJ, Salbach NM, Emond M. Effectiveness of Exercise in Older Adults Discharged From the ER After Minor Injuries: The CEDeComS Stepped-Wedge Trial. J Am Geriatr Soc. 2025 Oct 20. doi: 10.1111/jgs.70166. Online ahead of print.

Reference Type DERIVED
PMID: 41116303 (View on PubMed)

Sirois MJ, Carmichael PH, Daoust R, Eagles D, Griffith L, Lang E, Lee J, Perry JJ, Veillette N, Emond M; Canadian Emergency Team Initiative on Mobility in Aging. Functional Decline After Nonhospitalized Injuries in Older Patients: Results From the Canadian Emergency Team Initiative Cohort in Elders. Ann Emerg Med. 2022 Aug;80(2):154-164. doi: 10.1016/j.annemergmed.2022.01.041. Epub 2022 Mar 16.

Reference Type DERIVED
PMID: 35305850 (View on PubMed)

Other Identifiers

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364485

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MP-20-2017-3235

Identifier Type: -

Identifier Source: org_study_id

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