RecruitingNot Applicable

Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions

United States160 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: At baseline and repeated on a schedule (approximately every three months) for up to 12 months

Trial details

NCT IDNCT02592291

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Zara Ambadar, Ph.D.

412-608-6118 ambadarz@upmc.edu

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)