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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Other: Workbook support; Device: HIP Mobile e-Monitoring support

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montréal, Quebec, Canada, H3T 1M5
      • St. Mary's Hospital Center
    • Montréal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Workbook support group; Printed educational workbook and pedometer.	Other: Workbook support; Printed material support
Experimental: HIP Mobile e-Monitoring support group; Remote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet.	Device: HIP Mobile e-Monitoring support; 3-month community-based extended-rehabilitation e-Monitoring and Coaching support program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in grip strength	Measured using a Jamar™ hand dynamometer.	0, 1, 3, and 7 months
Change in walking endurance	Measured using the 2-minute walk test.	0, 1, 3, and 7 months
Change in balance	Measured using the Berg Balance Scale.	0, 1, 3, and 7 months
Change in the spatial area an individual moves through	Measured using the Life Space Mobility Assessment	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in global function status	Measured using the Reintegration to Normal Living Index (RNLI)	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in perceived physical health status	Measured by the physical function subscale of the RAND-36	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in Health-related quality of life	Measured by the EQ-5D	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in patient-reported health perception	Measured by the How Are You Today? Visual Analog Health States	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in goal directed behavior	Measured by the Apathy Evaluation Scale	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in global quality of life (QOL)	Measured by Patient Generated Index (PGI)	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in cognition	Measured by the Perceived Deficits Questionnaire (PDQ)	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in confidence in maintaining balance while doing daily activities.	Measured by the Activities-specific Balance Confidence Scale (ABC-S)	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); Greybox Solutions Inc.
• Investigators: Principal Investigator: Suzanne Morin, MD, Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: 15-248-MUHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No