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

Primary Purpose

Elderly, Functional Status

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise program
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Elderly focused on measuring Frail, Prefrail, Mobile decline

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesAccepts 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

Sites / Locations

  • Alberta Health Services
  • Alberta Health Services
  • Sunnybrook Health Science Center
  • Ottawa Hospital Research Institute
  • Hôpital Sacré-CoeurRecruiting
  • CHU-QuébecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

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

During the first 6 months and throughout CTRL time

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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)

Full Information

First Posted
July 19, 2017
Last Updated
June 18, 2019
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Université du Québec a Montréal, University of Toronto, Laval University, Hopital du Sacre-Coeur 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)
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1. Study Identification

Unique Protocol Identification Number
NCT03991598
Brief Title
Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors
Acronym
CEDeComS
Official Title
Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors (CEDeComS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Université du Québec a Montréal, University of Toronto, Laval University, Hopital du Sacre-Coeur 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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly, Functional Status
Keywords
Frail, Prefrail, Mobile decline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a step-wedge clinical trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
EDs 1 to 7 will then be randomly phased-in INT every 3 months.
Arm Title
control
Arm Type
No Intervention
Arm Description
During the first 6 months and throughout CTRL time
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Exercise program in communities / Exercise program at home
Primary Outcome Measure Information:
Title
Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline)
Description
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)
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
Secondary Outcome Measure Information:
Title
Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline)
Description
The SPPB (Short Physical Portable Battery) combines walking, balance and strength items. Scores range from 0 to 12 (best).
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
Title
Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline)
Description
The SOF index is a Frailty measure. Scores range from 0/3 (robust senior) to 3/3 (frail senior)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Josée MJ Sirois, Ph.D
Phone
418-649-0252
Ext
66244
Email
marie-josee.sirois@rea.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine SH Hegg, Ph.D
Phone
418-649-0252
Ext
64293
Email
ceti.mobility@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel ME Emond, Md, Ph.D
Organizational Affiliation
Centre de recherche du CHU de Québec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddy lang, MD, MSc
Email
Eddy.Lang@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Tristan holotnak, MSc
Email
Tristan.Holotnak@albertahealthservices.ca
Facility Name
Alberta Health Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
TG2 2C8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Rowe, MD. MSc
Email
browe@ualberta.ca
First Name & Middle Initial & Last Name & Degree
natalie runham, MSc
Email
nrunham@ualberta.ca
Facility Name
Sunnybrook Health Science Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontaro
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Perry, MD, MSc
Email
jperry@ohri.ca
First Name & Middle Initial & Last Name & Degree
cathy Clement, MSc
Email
jperry@ohri.ca
First Name & Middle Initial & Last Name & Degree
debra Eagles, MD
Facility Name
Hôpital Sacré-Coeur
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul daoust, MD, MSc
Phone
514-338-2222
Ext
3318
Email
raoul.daoust@videotron.ca
First Name & Middle Initial & Last Name & Degree
chantal lanthier, RN
Phone
514-338-2222
Ext
3318
Email
chantal.lanthier@crhsc.rtss.qc.ca
Facility Name
CHU-Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
marie-josée sirois, PhD
Phone
418-649-0252
Ext
64293
Email
marie-josee.sirois@rea.ulaval.ca
First Name & Middle Initial & Last Name & Degree
sandrine hegg, Phd
Phone
418-649-0252
Ext
64293
Email
ceti.mobility@gmail.com
First Name & Middle Initial & Last Name & Degree
marcel émond, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35305850
Citation
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.
Results Reference
derived

Learn more about this trial

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

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