Spinal Cord InjuriesNCT02592291
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions
A study testing MHealth in people with Spinal Cord Injuries and Cerebral Palsy, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Cerebral Palsy, Spinal Dysraphism
- What is being tested?
- MHealth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Zara Ambadar, Ph.D., 412-608-6118, ambadarz@upmc.edu
About this study
Official title: Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries, Cerebral Palsy, Spinal Dysraphism, Brain Injuries, Spina Bifida, Traumatic Brain Injury
- Being tested
- MHealth
- Keywords
- Mobile health, Apps, Applications, Smart phone, mHealth, Chronic and Complex Conditions, Self-Management, Self-Care
- Medical subject headings
- Spinal Cord Injuries, Cerebral Palsy, Spinal Dysraphism, Brain Injuries, Brain Injuries, Traumatic, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHealthDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MHealth Group | Experimental | Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care Receives: Device: MHealth |
| Control | No intervention | Participants randomized into this group will not use the mHealth system throughout the study, but will continue with their standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
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.
Measured: 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.
Measured: Through study completion, an average of 1 year.
Cost of care
Estimated total cost of medical care.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start1 Oct 2019
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Andi Saptono, University of Pittsburgh
- Investigators
- Andi Saptono, Ph.D., Principal investigator, University of PittsburghBambang Parmanto, Ph.D., Study director, University of PittsburghBrad E. Dicianno, M.D., Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592291
- Sponsor's protocol ID
- STUDY19040337
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2015
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kryger MA, Crytzer TM, Fairman A, Quinby EJ, Karavolis M, Pramana G, Setiawan IMA, McKernan GP, Parmanto B, Dicianno BE. The Effect of the Interactive Mobile Health and Rehabilitation System on Health and Psychosocial Outcomes in Spinal Cord Injury: Randomized Controlled Trial. J Med Internet Res. 2019 Aug 28;21(8):e14305. doi: 10.2196/14305.
PubMed 31464189