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

Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Brain Injuries; Traumatic Brain Injury; Spinal Cord Injuries; Spinal Dysraphism; Spina Bifida
• Intervention / Treatment: Device: MHealth

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zara Ambadar, Ph.D.; Phone Number: 412-608-6118; Email: ambadarz@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • University of Pittsburgh
      • Contact: Zara Ambadar, Ph.D.; Phone Number: 412-608-6118; Email: ambadarz@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and repeated on a schedule (approximately every three months) for up to 12 months
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.	At baseline and repeated on a schedule (approximately every three months) for up to 12 months
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.	At baseline and repeated on a schedule (approximately every three months) for up to 12 months
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.	At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Psychosocial Outcomes- Change of Depressive Symptoms Over time as assessed by Depressive Symptoms questionnaire.	Questionnaire of Depressive symptoms administered at baseline, and approximately every three months for up to 12 months.	At baseline and repeated on a schedule (approximately every three months) for up to 12 months
Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review	Medical record review of number of wounds, number of urinary tract infections and occurrences of sepsis.	Through study completion, an average of 1 year.
Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.	Medical Record Review and questionnaire on Number of hospitalizations, number of visits to emergency room and urgent care centers.	Through study completion, an average of 1 year.
Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review	Medical Record Review on Length of stay of hospitalizations.	Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline and repeated on a schedule (approximately every three months) for up to 12 months)
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.	Through study completion, an average of 1 year.
Cost of care	Estimated total cost of medical care.	Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Andi Saptono, Ph.D., University of Pittsburgh; Study Director: Bambang Parmanto, Ph.D., University of Pittsburgh; Study Director: Brad E. Dicianno, M.D., University of Pittsburgh

Publications and helpful links

General Publications

• Kryger MA, Crytzer TM, Fairman A, Quinby EJ, Karavolis M, Pramana G, Setiawan IMA, McKernan GP, Parmanto B, Dicianno BE. The Effect of the Interactive Mobile Health and Rehabilitation System on Health and Psychosocial Outcomes in Spinal Cord Injury: Randomized Controlled Trial. J Med Internet Res. 2019 Aug 28;21(8):e14305. doi: 10.2196/14305.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimated): October 30, 2015

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: mHealth; Self-Management; Mobile health; Apps; Applications; Smart phone; Chronic and Complex Conditions; Self-Care
• Additional Relevant MeSH Terms: Organizing Pneumonia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Congenital Abnormalities; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Spinal Cord Diseases; Nervous System Malformations; Neural Tube Defects; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Injuries, Traumatic; Bronchiolitis Obliterans Syndrome; Brain Injuries; Cerebral Palsy; Spinal Cord Injuries; Spinal Dysraphism
• Other Study ID Numbers: STUDY19040337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No