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

August 30, 2021 updated by: Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
3-month community-based extended-rehabilitation e-Monitoring and Coaching support program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0, 1, 3, and 7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in grip strength
Time Frame: 0, 1, 3, and 7 months
Measured using a Jamar™ hand dynamometer.
0, 1, 3, and 7 months
Change in walking endurance
Time Frame: 0, 1, 3, and 7 months
Measured using the 2-minute walk test.
0, 1, 3, and 7 months
Change in balance
Time Frame: 0, 1, 3, and 7 months
Measured using the Berg Balance Scale.
0, 1, 3, and 7 months
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
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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)
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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)
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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)
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
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)
0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Greybox Solutions Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suzanne Morin, MD, Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-248-MUHC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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