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

Not Applicable
Completed
Conditions
Hip Fractures
Interventions
Other: Workbook support
Device: HIP Mobile e-Monitoring support
Registration Number
NCT03153943
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
63
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Workbook support groupWorkbook supportPrinted educational workbook and pedometer.
HIP Mobile e-Monitoring support groupHIP Mobile e-Monitoring supportRemote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet.
Primary Outcome Measures
NameTimeMethod
Change in mobility0, 1, 3, and 7 months

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.

Secondary Outcome Measures
NameTimeMethod
Change in grip strength0, 1, 3, and 7 months

Measured using a Jamar™ hand dynamometer.

Change in the spatial area an individual moves through0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured using the Life Space Mobility Assessment

Change in global function status0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured 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 months

Measured by the physical function subscale of the RAND-36

Change in walking endurance0, 1, 3, and 7 months

Measured using the 2-minute walk test.

Change in Health-related quality of life0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured by the EQ-5D

Change in global quality of life (QOL)0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured by Patient Generated Index (PGI)

Change in cognition0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured by the Perceived Deficits Questionnaire (PDQ)

Change in balance0, 1, 3, and 7 months

Measured using the Berg Balance Scale.

Change in patient-reported health perception0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured 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 months

Measured by the Apathy Evaluation Scale

Change in confidence in maintaining balance while doing daily activities.0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Measured by the Activities-specific Balance Confidence Scale (ABC-S)

Trial Locations

Locations (3)

St. Mary's Hospital Center

🇨🇦

Montréal, Quebec, Canada

Jewish General Hospital

🇨🇦

Montréal, Quebec, Canada

McGill University Health Centre

🇨🇦

Montréal, Quebec, Canada

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