An interventional study of MHealth in Spinal Cord Injuries, Cerebral Palsy and Spinal Dysraphism, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Supportive care
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.
Individuals with chronic and complex conditions such as those with spinal cord injury (SCI),Cerebral Palsy (CP), Spina Bifida (SB), and Traumatic Brain Injury (TBI), often require complex self-management routines to manage various needs such as bowel and bladder, skin integrity, and general health and wellness. Tasks such as self-catheterization, bowel regimens, skin checks, and routine administration of medications require consistent follow-through to prevent complications. Early detection and treatment of problems such as urinary tract infections (UTIs) or wounds, can prevent serious complications like osteomyelitis and sepsis which can result in hospitalization, death, and expensive medical care. The investigators have developed an innovative mobile health (mHealth) system aimed at improving self-management skills and preventing and detecting early signs of secondary medical complications. The system consist of a mobile health applications (apps), a clinician portal and a two-way secure communication system between the two. People with complex care regimens can use the apps to get reminders or cues to carry out their self care routines such as bowel/bladder routines, take medications, report success with their activities or new problems (e.g. new wound, UTI symptoms etc.), and track symptoms of depression. A clinician can use the portal to view the report and communicate with the users through a secure communication system that is embedded in the apps.
This study will assess the benefits of using the system in improving users' wellness and self-management skills compared to those who receive standard of care only.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 160 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care
Device: MHealth
Participants randomized into this group will not use the mHealth system throughout the study, but will continue with their standard of care.
The 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.
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.
Time frame: At baseline and repeated on a schedule (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.
Time frame: At baseline and repeated on a schedule (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.
Time frame: At baseline and repeated on a schedule (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.
Time frame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Psychosocial Outcomes- Change of Depressive Symptoms Over time as assessed by Depressive Symptoms questionnaire.
Questionnaire of Depressive symptoms administered at baseline, and approximately every three months for up to 12 months.
Time frame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review
Medical record review of number of wounds, number of urinary tract infections and occurrences of sepsis.
Time frame: Through study completion, an average of 1 year.
Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.
Medical Record Review and questionnaire on Number of hospitalizations, number of visits to emergency room and urgent care centers.
Time frame: Through study completion, an average of 1 year.
Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review
Medical Record Review on Length of stay of hospitalizations.
Time frame: Through study completion, an average of 1 year.
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.
Time frame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months)
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.
Time frame: Through study completion, an average of 1 year.
Cost of care
Estimated total cost of medical care.
Time frame: Through study completion, an average of 1 year.
Plan to share: No
Started Oct 2019 (actual). Primary completion is estimated for Sep 2026, 83 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 83 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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