NCT03153943

Brief Summary

Approximately 30,000 adults in Quebec over the age of 50 suffer a fragility fracture each year. Fractures can affect a person's health, well-being and autonomy. Personal costs of these fractures are high, with as many as 50% of hip fracture patients being unable to return their pre-fracture level of autonomy. Homecare and community services provide customary rehabilitation support immediately following discharge from acute-care, though this contribution can be limited by lack of resources. For those patients at risk of negative outcomes, we have demonstrated clinically important benefits of extended exercise rehabilitation programs offered beyond the regular rehabilitation period on improving physical function. Through advances in sensor and telecommunication technology, eHealth solutions incorporated within homecare services as an integral part of the continuum of care can lead to better patient and health professional experience, improve clinical outcomes and reduce costs to the healthcare system. The purpose of this study is to determine if the implementation of a 3-month community-based extended-rehabilitation e-Monitoring and Coaching support program is more effective at improving mobility in community-dwelling elderly patients who have sustained a fracture than a printed material support program, and if these effects persist 6 months after discontinuation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

May 10, 2017

Last Update Submit

August 30, 2021

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Change in mobility

    Measured as an ordinal mobility response variable quantified by the number of minimal clinically important changes (MIC) a participant attains using the gait speed and 30 second Sit to Stand tests. A person making no MIC in either measure is given a response category of 0, the lowest. A person changing by 1 MIC on only of the measures (either one) will be given a value of 1; a MIC gain on both measures would be assigned a value of 2, and so forth.

    0, 1, 3, and 7 months

Secondary Outcomes (12)

  • Change in grip strength

    0, 1, 3, and 7 months

  • Change in walking endurance

    0, 1, 3, and 7 months

  • Change in balance

    0, 1, 3, and 7 months

  • Change in the spatial area an individual moves through

    0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

  • Change in global function status

    0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

  • +7 more secondary outcomes

Study Arms (2)

Workbook support group

EXPERIMENTAL

Printed educational workbook and pedometer.

Other: Workbook support

HIP Mobile e-Monitoring support group

EXPERIMENTAL

Remote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet.

Device: HIP Mobile e-Monitoring support

Interventions

HIP Mobile e-Monitoring supportDEVICE

3-month community-based extended-rehabilitation e-Monitoring and Coaching support program

HIP Mobile e-Monitoring support group
Workbook supportOTHER

Printed material support

Workbook support group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community dwelling men and women aged ≥ 60 years
  • Treated for any fracture excluding hands, feet, patella, cervical spine, skull, ribs, or clavicle, at any of the 3 participating sites, within the previous 8 weeks.

You may not qualify if:

  • Upper limb fractures that do not meet the criteria of gait frailty
  • Multiple traumas
  • Open fractures
  • Pathological fractures
  • Inability to communicate adequately in either French or English
  • Inability to give written informed consent
  • Discharge to a long-term care institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

McGill University Health Centre

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Suzanne Morin, MD

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pragmatic randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 15, 2017

Study Start

March 29, 2017

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)