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Trial record 34 of 127 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Injuries"

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

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ClinicalTrials.gov Identifier: NCT03153943
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Greybox Solutions Inc.
Information provided by (Responsible Party):
Suzanne Morin, McGill University Health Center

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 4-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.


Condition or disease Intervention/treatment Phase
Hip Fractures Device: HIP Mobile e-Monitoring support Other: Workbook support Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pragmatic randomized trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Hip Fracture
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : March 29, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in mobility [ Time Frame: 0, 1, 4, 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 :
  1. Change in grip strength [ Time Frame: 0, 1, 4, and 7 months ]
    Measured using a Jamar™ hand dynamometer.

  2. Change in walking endurance [ Time Frame: 0, 1, 4, and 7 months ]
    Measured using the 2-minute walk test.

  3. Change in balance [ Time Frame: 0, 1, 4, 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)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153943


Contacts
Contact: Study Coordinator (514) 934-1934 ext 45742 michelle.wall@mail.mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: Study Coordinator    (514) 934-1934 ext 45742    michelle.wall@mail.mcgill.ca   
Jewish General Hospital Recruiting
Montréal, Quebec, Canada, H3T 1E2
Contact: Stephane Bergeron, MD         
St. Mary's Hospital Center Recruiting
Montréal, Quebec, Canada, H3T 1M5
Contact: Anthony Albers, MD         
Sponsors and Collaborators
McGill University Health Center
Canadian Institutes of Health Research (CIHR)
Greybox Solutions Inc.
Investigators
Principal Investigator: Suzanne Morin, MD Research Institute of the McGill University Health Centre

Responsible Party: Suzanne Morin, Dr., McGill University Health Center
ClinicalTrials.gov Identifier: NCT03153943     History of Changes
Other Study ID Numbers: 15-248-MUHC
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries