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

L

Laval University

Status

Unknown

Conditions

Elderly
Functional Status

Treatments

Other: Exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT03991598
MP-20-2017-3235
364485 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

65 to 120 years old

Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,500 participants in 2 patient groups

intervention
Experimental group
Description:
EDs 1 to 7 will then be randomly phased-in INT every 3 months.
Treatment:
Other: Exercise program
control
No Intervention group
Description:
During the first 6 months and throughout CTRL time

Trial contacts and locations

6

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Central trial contact

Marie-Josée MJ Sirois, Ph.D; Sandrine SH Hegg, Ph.D

Data sourced from clinicaltrials.gov

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