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

Study Overview
=================
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.

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

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Device: HIP Mobile e-Monitoring support
* Other: Workbook support


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Workbook support group<br>Printed educational workbook and pedometer. | Other: Workbook support<br>* Printed material support<br>|
| Experimental: HIP Mobile e-Monitoring support group<br>Remote monitoring via smart shoe insoles and a coaching with enabling educational electronic program accessed through a tablet. | Device: HIP Mobile e-Monitoring support<br>* 3-month community-based extended-rehabilitation e-Monitoring and Coaching support program<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 1, 3, and 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in grip strength | Measured using a Jamar™ hand dynamometer. | 0, 1, 3, and 7 months | 
| Change in walking endurance | Measured using the 2-minute walk test. | 0, 1, 3, and 7 months | 
| Change in balance | Measured using the Berg Balance Scale. | 0, 1, 3, and 7 months | 
| Change in the spatial area an individual moves through | 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 | 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 | 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 | Measured by the EQ-5D | 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 | 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months | 
| Change in goal directed behavior | 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) | Measured by Patient Generated Index (PGI) | 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months | 
| Change in cognition | 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. | Measured by the Activities-specific Balance Confidence Scale (ABC-S) | 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months |