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Completed

NCT Number: NCT03153943

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIP Mobile e-Monitoring support

Device

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

Workbook support

Other

Printed material support

Primary outcomes

  1. Change in mobility

    Time frame: 0, 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 outcomes

  1. Change in grip strength

    Time frame: 0, 1, 3, and 7 months

    Measured using a Jamar™ hand dynamometer.

  2. Change in walking endurance

    Time frame: 0, 1, 3, and 7 months

    Measured using the 2-minute walk test.

  3. Change in balance

    Time frame: 0, 1, 3, and 7 months

    Measured using the Berg Balance Scale.

  4. Change in the spatial area an individual moves through

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

    Measured using the Life Space Mobility Assessment

  5. Change in global function status

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

    Measured using the Reintegration to Normal Living Index (RNLI)

  6. Change in perceived physical health status

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

    Measured by the physical function subscale of the RAND-36

  7. Change in Health-related quality of life

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

    Measured by the EQ-5D

  8. Change in patient-reported health perception

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

    Measured by the How Are You Today? Visual Analog Health States

  9. Change in goal directed behavior

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

    Measured by the Apathy Evaluation Scale

  10. Change in global quality of life (QOL)

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

    Measured by Patient Generated Index (PGI)

  11. Change in cognition

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

    Measured by the Perceived Deficits Questionnaire (PDQ)

  12. Change in confidence in maintaining balance while doing daily activities.

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

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Greybox Solutions Inc.

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 15, 2017
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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