Mobile Health System to Support Self-Management in Chronic and Complex Conditions like Spinal Cord Injury, Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury
Led by University of Pittsburgh · Updated on 2025-10-03
160
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile health mHealth system designed to help individuals with chronic and complex health conditions such as spinal cord injury, cerebral palsy, spina bifida, and traumatic brain injury. The study aims to determine if this system can improve wellness and self-management skills compared to standard care alone. These conditions often require detailed self-care routines to manage bowel and bladder health, skin integrity, and medication adherence to prevent serious complications.
The mHealth system includes a suite of mobile applications for participants and a clinician portal for healthcare providers. Participants randomized to the intervention group will use the apps for one year alongside their standard care. The apps provide reminders for self-care tasks like bowel and bladder routines, medication intake, symptom tracking, and reporting new issues such as wounds or urinary tract infection symptoms. Clinicians can monitor reports and communicate securely with users through the system. Participants in the control group will continue with standard care without using the mHealth system.
Participants will be involved for approximately one year, during which they will complete questionnaires about self-management skills, perceived function, quality of life, physical independence, and depressive symptoms every three months. Medical records will be reviewed to assess preventable conditions and healthcare utilization. The study also monitors participants experiences using the system and tracks usage data. Safety and effectiveness outcomes are measured through repeated assessments and record reviews throughout the study period.
CONDITIONS
Brief Title
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions
Research Team
Z
Zara Ambadar, Ph.D.
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
mHealth Digital Self-Management
Usual Care Only
What is it?
A digital self-management and support system consisting of a suite of mobile apps for participants and a clinician portal. Used for one year by people living in the community with chronic neurological conditions.
Usual care for chronic and complex neurologic disabilities. Participants continue their existing health management routines without the mHealth system.
Role in the study
Experimental arm; investigates whether using mHealth tools improves outcomes over one year.
Control arm; provides a baseline for comparison to see if mHealth offers benefits beyond current usual care.
Primary use or purpose
Supports daily self-management, clinician communication, and tracking for people with neurological disorders to improve psychosocial and medical outcomes.
Represents the standard way people manage their health without extra digital support tools.
How is it given or performed?
Participants receive access to the mHealth app suite and clinician portal; they use it independently in everyday life for up to 12 months.
Participants do not use the mHealth system; they continue with personal and clinician-supported routines as before.
Evidence status
This mHealth system is being evaluated in a randomized trial for its effect on self-management, psychosocial outcomes, and health care use. Published evidence suggests mobile health can support improved health behaviors in related populations, but conclusive results for this specific tool are still pending.
Usual care does not include structured mobile health support. Published evidence describes health outcomes as variable depending on access to resources and self-management ability.
Important limitations
Effects of the mHealth system may depend on participants' ability to use technology and access to smartphones. Long-term benefits and risks specific to this tool are not yet fully known.
Usual care may not provide tailored digital self-management support. Outcomes can be influenced by variability in personal resources and system-level support.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 12Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
12 years or older
Diagnosed with a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy, or Traumatic Brain Injury
Living in a community setting (not in a residential care facility)
Able to use a smartphone and pass functional screening tests
You will not qualify if you...
Diagnosed with severe intellectual disability or severe and persistent psychiatric illness
Unable to use the mHealth system due to severe impairments that cannot be accommodated by the system (failed screening tests)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 year
Participants use the mHealth system to support self-management of their chronic and complex health conditions while continuing with their standard care, or continue with standard care alone if in the control group.
Visits approximately every 3 months for assessments
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
The Effect of the Interactive Mobile Health and Rehabilitation System on Health and Psychosocial Outcomes in Spinal Cord Injury: Randomized Controlled Trial.
Michael Alan Kryger, Theresa M Crytzer, Andrea Fairman...