HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Fracture

NCT ID: NCT03153943

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2021-01-22

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Workbook support group

Printed educational workbook and pedometer.

Group Type: EXPERIMENTAL

Workbook support

Intervention Type: OTHER

Printed material support

HIP Mobile e-Monitoring support group

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

Group Type: EXPERIMENTAL

HIP Mobile e-Monitoring support

Intervention Type: DEVICE

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

Interventions

HIP Mobile e-Monitoring support

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

Intervention Type: DEVICE

Workbook support

Printed material support

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Greybox Solutions Inc.

UNKNOWN

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Suzanne Morin

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Morin, MD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

St. Mary's Hospital Center

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

15-248-MUHC

Identifier Type: -

Identifier Source: org_study_id