Recruiting

Mobile Health

Sponsor:

University of Pittsburgh

Code:

NCT02592291

Conditions

Spinal Cord Injuries

Cerebral Palsy

Spinal Dysraphism

Brain Injuries

Spina Bifida

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

MHealth

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Cerebral Palsy

Spinal Dysraphism

Brain Injuries

Spina Bifida

Study ID

NCT02592291

Start date

Oct 1, 2019

Status verified date

Sep, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 12 years or older.
2. have a diagnosis of a chronic and complex condition such as Spina Bifida, Spinal Cord Injury, Cerebral Palsy and Traumatic Brain Injury, etc.
3. live in a community setting (not within a residential facility that provides care to them).
4. pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments

Exclusion Criteria:

1. Diagnosis of severe intellectual disability or severe and persistent psychiatric illness.
2. Failing all the screening tests due to severe impairments that cannot be accommodated by the mHealth system (for patient participants)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MHealth Group

Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care

no intervention: Control

Participants randomized into this group will not use the mHealth system throughout the study, but will continue with their standard of care.

Interventions

MHealth

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.

Primary outcome measure

  • Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire [ 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. [ 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. [ 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. [ 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. [ 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 [ 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. [ Time Frame: Through study completion, an average of 1 year. ]
  • Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts and Locations

Central contacts

Zara Ambadar, Ph.D.

412-608-6118ambadarz@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Zara Ambadar, Ph.D.

412-608-6118ambadarz@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Mobile health
  • Apps
  • Applications
  • Smart phone
  • mHealth
  • Chronic and Complex Conditions
  • Self-Management
  • Self-Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-09-03.