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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153943
• Other study ID #: 15-248-MUHC
• Status: Completed
• Phase: N/A
• Start date: March 29, 2017
• Est. completion date: January 22, 2021

Study information

• Verified date: August 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Device:
• HIP Mobile e-Monitoring support
3-month community-based extended-rehabilitation e-Monitoring and Coaching support program

Other:
• Workbook support
Printed material support

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec
Canada	McGill University Health Centre	Montréal	Quebec
Canada	St. Mary's Hospital Center	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR), Greybox Solutions Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in grip strength	Measured using a Jamar™ hand dynamometer.	0, 1, 3, and 7 months
Secondary	Change in walking endurance	Measured using the 2-minute walk test.	0, 1, 3, and 7 months
Secondary	Change in balance	Measured using the Berg Balance Scale.	0, 1, 3, and 7 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in goal directed behavior	Measured by the Apathy Evaluation Scale	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Secondary	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
Secondary	Change in cognition	Measured by the Perceived Deficits Questionnaire (PDQ)	0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 months
Secondary	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