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

  • STATUS
    Recruiting
  • End date
    Sep 17, 2023
  • participants needed
    160
  • sponsor
    University of Pittsburgh
Updated on 7 October 2022
cerebral palsy
spina bifida
spinal cord
traumatic brain injury
spinal cord disorder
incomplete spinal cord injury
spinal cord disease
Accepts healthy volunteers

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.

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.

Details
Condition Spinal Cord Injuries, Cerebral Palsy, Spinal Dysraphism, Brain Injuries, Spina Bifida, Traumatic Brain Injury
Treatment mHealth
Clinical Study IdentifierNCT02592291
SponsorUniversity of Pittsburgh
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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