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

University of Pittsburgh

Status: Enrolling

Conditions: Brain Injuries; Traumatic Brain Injury; Spina Bifida; Spinal Cord Injuries; Cerebral Palsy; Spinal Dysraphism

Treatments: Device: MHealth

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02592291

STUDY19040337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

MHealth Group

Experimental group

Description:

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

Treatment:

Device: MHealth

Control

No Intervention group

Description:

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