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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Pittsburgh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: MHealth GroupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline and repeated on a schedule (approximately every three months) for up to 12 months
2

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.

Time frame
At baseline and repeated on a schedule (approximately every three months) for up to 12 months
3

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.

Time frame
At baseline and repeated on a schedule (approximately every three months) for up to 12 months
4

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.

Time frame
At baseline and repeated on a schedule (approximately every three months) for up to 12 months

Secondary outcomes

1

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.

Time frame
At baseline and repeated on a schedule (approximately every three months) for up to 12 months)
2

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.

Time frame
Through study completion, an average of 1 year.
3

Cost of care

Estimated total cost of medical care.

Time frame
Through study completion, an average of 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

Department of Health and Human Services

Collaborator