Clinical trial NCT03153943: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Greybox Solutions Inc.
First posted: 2017-05-15
Enrollment: 63
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in mobility
timeFrame: 0, 1, 3, and 7 months
Secondary outcomes:
measure: Change in grip strength
timeFrame: 0, 1, 3, and 7 months
measure: Change in walking endurance
timeFrame: 0, 1, 3, and 7 months
measure: Change in balance
timeFrame: 0, 1, 3, and 7 months
measure: Change in the spatial area an individual moves through
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in global function status
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in perceived physical health status
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in Health-related quality of life
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in patient-reported health perception
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in goal directed behavior
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in global quality of life (QOL)
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in cognition
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
measure: Change in confidence in maintaining balance while doing daily activities.
timeFrame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Suzanne Morin, MD
role: PRINCIPAL_INVESTIGATOR
References: