About this trial
This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
12 years or older.
have a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.
live in a community setting (not within a residential facility that provides care to them).
pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments
Disqualifiers
Diagnosis of severe intellectual disability or severe and persistent psychiatric illness.
Failing all the screening tests due to severe impairments that cannot be accommodated by the mHealth system (for patient participants)
Trial design
Parallel
Treatments tested in this trial
MHealth
DeviceThe Mhealth system consists of a suite of apps to support participants manage their self-care and the clinician portal. Participants will use the system for 1 year.
Treatment groups
Trial outcomes
Primary outcomes
Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire
Self management skill ratings measured at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes-Change of Perceived Function and Satisfaction Over Time as assessed by Perceived Function and Satisfaction questionnaire.
Self ratings on perceived function and satisfaction questionnaire, assessed at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes-Change of Quality of Life Over Time as assessed by Quality of Life questionnaire.
Quality of life ratings measured at baseline, and approximately every three months for up to 12 months.
Psychosocial Outcomes-Change of Function Ratings Over Time as assessed by Function or Physical Independence questionnaire.
Scale of Function measured at baseline, and approximately every three months for up to 12 months.
Secondary outcomes
Change of Participants' experience using the mHealth system over time as assessed by questionnaire
Questionnaire to assess participants subjective feelings about the use of the apps. This is for the MHealth group only.
Usage of the system as assessed by questionnaire and record review of the system usage (a built-in function in the system)
Questionnaire and review of usage record (a built-in function in the system) to measure the extent to which participants in the MHealth group consistently use the system to carry out their own self-management routines.
Cost of care
Estimated total cost of medical care.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Department of Health and Human Services
Collaborator