Hip FracturesNCT03153943
HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Fracture
A study testing HIP Mobile e-Monitoring support and Workbook support in people with Hip Fractures, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- HIP Mobile e-Monitoring support and Workbook support
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 3 sitesCanada
- Study dates
- 29 Mar 2017to 22 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McGill University Health Centre
Montreal, Quebec, H3G 1A4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5
About this study
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.
Read more
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.
- Conditions
- Hip Fractures
- Being tested
- HIP Mobile e-Monitoring support, Workbook support
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP Mobile e-Monitoring supportDevice
3-month community-based extended-rehabilitation e-Monitoring and Coaching support program
Workbook supportOther
Printed material support
| Study group | Role | What they receive |
|---|---|---|
| Workbook support group | Experimental | Printed educational workbook and pedometer. Receives: Other: Workbook support |
| HIP Mobile e-Monitoring support group | Experimental | Remote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet. Receives: Device: HIP Mobile e-Monitoring support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 1, 3, and 7 months
Secondary outcomes (12)
Change in grip strength
Measured using a Jamar™ hand dynamometer.
Measured: 0, 1, 3, and 7 months
Change in walking endurance
Measured using the 2-minute walk test.
Measured: 0, 1, 3, and 7 months
Change in balance
Measured using the Berg Balance Scale.
Measured: 0, 1, 3, and 7 months
Change in the spatial area an individual moves through
Measured using the Life Space Mobility Assessment
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in global function status
Measured using the Reintegration to Normal Living Index (RNLI)
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in perceived physical health status
Measured by the physical function subscale of the RAND-36
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in Health-related quality of life
Measured by the EQ-5D
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in patient-reported health perception
Measured by the How Are You Today? Visual Analog Health States
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in goal directed behavior
Measured by the Apathy Evaluation Scale
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in global quality of life (QOL)
Measured by Patient Generated Index (PGI)
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in cognition
Measured by the Perceived Deficits Questionnaire (PDQ)
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Change in confidence in maintaining balance while doing daily activities.
Measured by the Activities-specific Balance Confidence Scale (ABC-S)
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start29 Mar 2017
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Greybox Solutions Inc.
- Responsible party
- Principal investigator, Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Suzanne Morin, MD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153943
- Sponsor's protocol ID
- 15-248-MUHC
- Status last verified
- Aug 2021
- First submitted
- 10 May 2017
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIP Mobile: A Community-based Monitoring, Rehabilitation and Learning e-System for Patients Following a Fracture
- ClinicalTrials.gov ID
- NCT03153943
- Acronym / sponsor ID
- 15-248-MUHC
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Greybox Solutions Inc.
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic randomized trial
| Arm | Type | Receives |
|---|---|---|
| Workbook support group | Experimental | Other: Workbook supportPrinted educational workbook and pedometer. |
| HIP Mobile e-Monitoring support group | Experimental | Device: HIP Mobile e-Monitoring supportRemote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIP Mobile e-Monitoring support3-month community-based extended-rehabilitation e-Monitoring and Coaching support program | Device | HIP Mobile e-Monitoring support group |
| Workbook supportPrinted material support | Other | Workbook support group |
Primary outcome
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.
12 secondary outcomes
Change in grip strength
Time frame: 0, 1, 3, and 7 months
Change in walking endurance
Time frame: 0, 1, 3, and 7 months
Change in balance
Time frame: 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
Change in global function status
Time frame: 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
Change in Health-related quality of life
Time frame: 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
Change in goal directed behavior
Time frame: 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
Change in cognition
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Morin, MD principal investigator
Research Institute of the McGill University Health Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIP Mobile e-Monitoring support and Workbook support in people with Hip Fractures, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mobility (time frame: 0, 1, 3, and 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.