Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
Healthy Volunteers
ID02592291

Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)

Led by University of Pittsburgh · Updated on 2025-10-03

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

D

Department of Health and Human Services

Collaborating Sponsor

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

Who Can Participate

Age: 12Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Actively Recruiting

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Research Team

Z

Zara Ambadar, Ph.D.

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...

https://pubmed.ncbi.nlm.nih.gov/31464189