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CompletedNCT03153943Updated Sep 1, 2021

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

An interventional study of HIP Mobile e-Monitoring support and Workbook support in Hip Fractures, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 3 sites in Canada. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hip Fractures

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03

In context

Hip Fractures

848 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.

This study's enrollment of 63 is below the median of 90 across 540 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Workbook support group

    Printed educational workbook and pedometer.

    Other: Workbook 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

Interventions

  • DeviceHIP Mobile e-Monitoring support

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

  • OtherWorkbook support

    Printed material support

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Change in grip strength

    Measured using a Jamar™ hand dynamometer.

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

  2. Change in walking endurance

    Measured using the 2-minute walk test.

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

  3. Change in balance

    Measured using the Berg Balance Scale.

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

  4. Change in the spatial area an individual moves through

    Measured using the Life Space Mobility Assessment

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

  5. Change in global function status

    Measured using the Reintegration to Normal Living Index (RNLI)

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

  6. Change in perceived physical health status

    Measured by the physical function subscale of the RAND-36

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

  7. Change in Health-related quality of life

    Measured by the EQ-5D

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

  8. Change in patient-reported health perception

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

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

  9. Change in goal directed behavior

    Measured by the Apathy Evaluation Scale

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

  10. Change in global quality of life (QOL)

    Measured by Patient Generated Index (PGI)

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

  11. Change in cognition

    Measured by the Perceived Deficits Questionnaire (PDQ)

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

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

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

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

07

Study locations

3 sites
  • McGill University Health Centre
    Montreal, Quebec H3G 1A4, Canada
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
  • St. Mary's Hospital Center
    Montreal, Quebec H3T 1M5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Jan 2021, 45 months.

Of 225 non-industry interventional studies with no phase under Hip Fractures, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's 45 months is above that.

Counting every sponsor, half of 239 studies reached it within 29 months; a quarter within 10 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2017
First posted
May 15, 2017
StartActual
Mar 29, 2017
Primary completionActual
Jan 22, 2021
CompletionActual
Jan 22, 2021
Last update
Sep 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03153943
Collaborators
Canadian Institutes of Health Research (CIHR), Greybox Solutions Inc.
Responsible party
Suzanne Morin (Dr., McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
May 15, 2017
Start date
Mar 29, 2017
Primary completion
Jan 22, 2021
Completion
Jan 22, 2021
Last update
Sep 1, 2021

Study contacts

Suzanne Morin, MD
principal investigator · Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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