ElderlyCEDeComSNCT03991598
Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors
A study testing Exercise program in people with Elderly and Functional Status, run by CHU de Quebec-Universite Laval at 6 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Functional Status
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 6 sitesCanada
- Study dates
- 1 Jul 2017to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites, 5 recruiting
- Not yet recruiting
Alberta Health Services
Calgary, Alberta, T2N 2T9
Eddy lang, MD, MSc, Eddy.Lang@albertahealthservices.ca
Tristan holotnak, MSc, Tristan.Holotnak@albertahealthservices.ca
- Not yet recruiting
Alberta Health Services
Edmonton, Alberta, TG2 2C8
Brian Rowe, MD. MSc, browe@ualberta.ca
natalie runham, MSc, nrunham@ualberta.ca
- Recruiting
Hôpital Sacré-Coeur
Montreal, Quebec, H4J 1C5
Raoul daoust, MD, MSc, 514-338-2222 ext. 3318, raoul.daoust@videotron.ca
chantal lanthier, RN, 514-338-2222 ext. 3318, chantal.lanthier@crhsc.rtss.qc.ca
- Not yet recruiting
Ottawa Hospital Research Institute
Ottawa, Ontaro, K1Y 4E9
Jeff Perry, MD, MSc, jperry@ohri.ca
cathy Clement, MSc, jperry@ohri.ca
- Recruiting
CHU-Québec
Québec, Quebec, G1J 1Z4
marie-josée sirois, PhD, 418-649-0252 ext. 64293, marie-josee.sirois@rea.ulaval.ca
sandrine hegg, Phd, 418-649-0252 ext. 64293, ceti.mobility@gmail.com
- Active, not recruiting
Sunnybrook Health Science Center
Toronto, Ontario, M4N 3M5
About this study
Official title: 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.
Read the 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.
- Conditions
- Elderly, Functional Status
- Being tested
- Exercise program
- Keywords
- Frail, Prefrail, Mobile decline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Exercise program in communities / Exercise program at home
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | EDs 1 to 7 will then be randomly phased-in INT every 3 months. Receives: Other: Exercise program |
| control | No intervention | During the first 6 months and throughout CTRL time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline)
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)
Measured: 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 outcomes (2)
Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline)
The SPPB (Short Physical Portable Battery) combines walking, balance and strength items. Scores range from 0 to 12 (best).
Measured: 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)
The SOF index is a Frailty measure. Scores range from 0/3 (robust senior) to 3/3 (frail senior)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jul 2017
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a step-wedge clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or 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)
- Responsible party
- Principal investigator, Marie-Josée Sirois, CHU de Quebec-Universite Laval
- Investigators
- Marcel ME Emond, Md, Ph.D, Principal investigator, Centre de recherche du CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991598
- Sponsor's protocol ID
- MP-20-2017-3235
- Other IDs
- 364485
- Acronym
- CEDeComS
- Status last verified
- Jun 2019
- First submitted
- 19 Jul 2017
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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. 2026 Jan;74(1):74-84. doi: 10.1111/jgs.70166. Epub 2025 Oct 20.
PubMed 41116303Sirois 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.
PubMed 35305850
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors (CEDeComS)
- ClinicalTrials.gov ID
- NCT03991598
- Acronym / sponsor ID
- CEDeComS / MP-20-2017-3235
- Conditions
- Elderly, Functional Status
- Keywords
- Frail, Prefrail, Mobile decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or 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)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a step-wedge clinical trial.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Exercise programEDs 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 |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programExercise program in communities / Exercise program at home | Other | intervention |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 41116303Sirois 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. 2026 Jan;74(1):74-84. doi: 10.1111/jgs.70166. Epub 2025 Oct 20.
- Derived from this study: PubMed 35305850Sirois 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel ME Emond, Md, Ph.D principal investigator
Centre de recherche du CHU de Québec
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Elderly and Functional Status, run by CHU de Quebec-Universite Laval at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Josée MJ Sirois, Ph.D (418-649-0252 ext. 66244, marie-josee.sirois@rea.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03991598, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.