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

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HIP Mobile e-Monitoring support
Workbook support
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University Health Centre
  • Jewish General Hospital
  • St. Mary's Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Workbook support group

HIP Mobile e-Monitoring support group

Arm Description

Printed educational workbook and pedometer.

Remote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in grip strength
Measured using a Jamar™ hand dynamometer.
Change in walking endurance
Measured using the 2-minute walk test.
Change in balance
Measured using the Berg Balance Scale.
Change in the spatial area an individual moves through
Measured using the Life Space Mobility Assessment
Change in global function status
Measured using the Reintegration to Normal Living Index (RNLI)
Change in perceived physical health status
Measured by the physical function subscale of the RAND-36
Change in Health-related quality of life
Measured by the EQ-5D
Change in patient-reported health perception
Measured by the How Are You Today? Visual Analog Health States
Change in goal directed behavior
Measured by the Apathy Evaluation Scale
Change in global quality of life (QOL)
Measured by Patient Generated Index (PGI)
Change in cognition
Measured by the Perceived Deficits Questionnaire (PDQ)
Change in confidence in maintaining balance while doing daily activities.
Measured by the Activities-specific Balance Confidence Scale (ABC-S)

Full Information

First Posted
May 10, 2017
Last Updated
August 30, 2021
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Greybox Solutions Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03153943
Brief Title
HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Fracture
Official Title
HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Greybox Solutions Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic randomized trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Workbook support group
Arm Type
Experimental
Arm Description
Printed educational workbook and pedometer.
Arm Title
HIP Mobile e-Monitoring support group
Arm Type
Experimental
Arm Description
Remote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet.
Intervention Type
Device
Intervention Name(s)
HIP Mobile e-Monitoring support
Intervention Description
3-month community-based extended-rehabilitation e-Monitoring and Coaching support program
Intervention Type
Other
Intervention Name(s)
Workbook support
Intervention Description
Printed material support
Primary Outcome Measure Information:
Title
Change in mobility
Description
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 Outcome Measure Information:
Title
Change in grip strength
Description
Measured using a Jamar™ hand dynamometer.
Time Frame
0, 1, 3, and 7 months
Title
Change in walking endurance
Description
Measured using the 2-minute walk test.
Time Frame
0, 1, 3, and 7 months
Title
Change in balance
Description
Measured using the Berg Balance Scale.
Time Frame
0, 1, 3, and 7 months
Title
Change in the spatial area an individual moves through
Description
Measured using the Life Space Mobility Assessment
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Title
Change in global function status
Description
Measured using the Reintegration to Normal Living Index (RNLI)
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Title
Change in perceived physical health status
Description
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
Title
Change in Health-related quality of life
Description
Measured by the EQ-5D
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Title
Change in patient-reported health perception
Description
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
Title
Change in goal directed behavior
Description
Measured by the Apathy Evaluation Scale
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Title
Change in global quality of life (QOL)
Description
Measured by Patient Generated Index (PGI)
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Title
Change in cognition
Description
Measured by the Perceived Deficits Questionnaire (PDQ)
Time Frame
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Title
Change in confidence in maintaining balance while doing daily activities.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Morin, MD
Organizational Affiliation
Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
St. Mary's Hospital Center
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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