Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors (CEDeComS)
| Registry | NCT03991598, acronym CEDeComS |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 1500 (Estimated) |
| Sponsor | CHU de Quebec-Universite Laval (Other); collaborators: Université du Québec a Montréal, University of Toronto, Laval University, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Ottawa Hospital Research Institute, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Alberta Health Services, Calgary, Sunnybrook Research Institute, Washington University School of Medicine, McMaster University, Mount Sinai Hospital, Canada, The Ottawa Hospital, Université de Montréal, University of Ottawa, Canadian Institutes of Health Research (CIHR) |
| Conditions | Elderly, Functional Status |
| Interventions | Exercise program (Other) |
| Dates | start 2017-07-01, primary completion 2020-06-01 (estimated), completion 2020-07-01 (estimated), first posted 2019-06-19, last updated 2019-06-19 |
| Locations | 6 sites in Canada |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| intervention | Experimental | Other: Exercise program | EDs 1 to 7 will then be randomly phased-in INT every 3 months. |
| control | No intervention | During the first 6 months and throughout CTRL time |
Sex: All, ages: 65 Years to 120 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Alberta Health Services | Calgary, Alberta | Canada | Not yet recruiting |
| Alberta Health Services | Edmonton, Alberta | Canada | Not yet recruiting |
| Sunnybrook Health Science Center | Toronto, Ontario | Canada | Active not recruiting |
| Ottawa Hospital Research Institute | Ottawa, Ontaro | Canada | Not yet recruiting |
| Hôpital Sacré-Coeur | Montreal, Quebec | Canada | Recruiting |
| CHU-Québec | Québec, Quebec | Canada | Recruiting |