Purpose

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

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MHealth Group
Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care
  • Device: 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.
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.

Recruiting Locations

University of Pittsburgh
Pittsburgh, Pennsylvania 15260
Contact:
Zara Ambadar, Ph.D.
412-608-6118
ambadarz@upmc.edu

More Details

Status
Recruiting
Sponsor
University of Pittsburgh

Study Contact

Zara Ambadar, Ph.D.
412-608-6118
ambadarz@upmc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.