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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT02592291
Status
Recruiting
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Conditions

  • Brain Injuries
  • Cerebral Palsy
  • Spina Bifida
  • Spinal Cord Injuries
  • Spinal Dysraphism
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • MHealth — DEVICE
    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 Details

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.

Key Dates

Start date
Oct 1, 2019
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire [ Time Frame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15260
Zara Ambadar, Ph.D.
[email protected]
412-608-6118

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