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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03153943
Enrollment
63
Registered
2017-05-15
Start date
2017-03-29
Completion date
2021-01-22
Last updated
2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

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.

Interventions

DEVICEHIP Mobile e-Monitoring support

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

OTHERWorkbook support

Printed material support

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Greybox Solutions Inc.
CollaboratorUNKNOWN
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Pragmatic randomized trial

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in mobility0, 1, 3, and 7 monthsMeasured 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.

Secondary

MeasureTime frameDescription
Change in walking endurance0, 1, 3, and 7 monthsMeasured using the 2-minute walk test.
Change in balance0, 1, 3, and 7 monthsMeasured using the Berg Balance Scale.
Change in the spatial area an individual moves through0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured using the Life Space Mobility Assessment
Change in global function status0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured using the Reintegration to Normal Living Index (RNLI)
Change in perceived physical health status0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by the physical function subscale of the RAND-36
Change in grip strength0, 1, 3, and 7 monthsMeasured using a Jamar™ hand dynamometer.
Change in patient-reported health perception0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by the How Are You Today? Visual Analog Health States
Change in goal directed behavior0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by the Apathy Evaluation Scale
Change in global quality of life (QOL)0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by Patient Generated Index (PGI)
Change in cognition0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by the Perceived Deficits Questionnaire (PDQ)
Change in confidence in maintaining balance while doing daily activities.0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by the Activities-specific Balance Confidence Scale (ABC-S)
Change in Health-related quality of life0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 monthsMeasured by the EQ-5D

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026