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

June 18, 2019 updated by: Marie-Josée Sirois, CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Active, not recruiting
        • Sunnybrook Health Science Center
    • Ontaro
      • Ottawa, Ontaro, Canada, K1Y 4E9
        • Not yet recruiting
        • Ottawa Hospital Research Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • debra Eagles, MD
    • Quebec
      • Montréal, Quebec, Canada, H4J 1C5
      • Quebec City, Quebec, Canada, G1J 1Z4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 120 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: intervention
EDs 1 to 7 will then be randomly phased-in INT every 3 months.
Other: Exercise program
Exercise program in communities / Exercise program at home
NO_INTERVENTION: control
During the first 6 months and throughout CTRL time

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline)
Time Frame: Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
Proportions of participants showing, at 3 or 6 months post-ED visit, a loss ≥2/28 on the OARS scale, compared to Baseline. (OARS: Older American Resource and Services multidimensional functional scale, which includes 7 basic ADLs and 7 instrumental ADLs items)
Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline)
Time Frame: Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
The SPPB (Short Physical Portable Battery) combines walking, balance and strength items. Scores range from 0 to 12 (best).
Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline)
Time Frame: Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
The SOF index is a Frailty measure. Scores range from 0/3 (robust senior) to 3/3 (frail senior)
Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Quebec-Universite Laval

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Washington University School of Medicine
Canadian Institutes of Health Research (CIHR)
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
McMaster University
University of Toronto
Ottawa Hospital Research Institute
The Ottawa Hospital
University of Ottawa
Mount Sinai Hospital, Canada
Laval University
Université de Montréal
Alberta Health Services, Calgary
Hopital du Sacre-Coeur de Montreal
Sunnybrook Research Institute
Université du Québec a Montréal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcel ME Emond, Md, Ph.D, Centre de recherche du CHU de Québec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-20-2017-3235
  • 364485 (OTHER_GRANT: CIHR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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