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

NCT02592291 | Recruiting

• 1 other identifier: STUDY19040337
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Keywords

Mobile health; Apps; Applications; Smart phone; mHealth; Chronic and Complex Conditions; Self-Management; Self-Care

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Change of Participants' experience using the mHealth system over time as assessed by questionnaire

  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)

  Through study completion, an average of 1 year.

• Cost of care

  Through study completion, an average of 1 year.

Study Arms (2)

MHealth Group

EXPERIMENTAL

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

Device: MHealth

Control

NO INTERVENTION

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

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.

MHealth Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 31464189 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Cerebral Palsy; Spinal Dysraphism; Brain Injuries; Brain Injuries, Traumatic; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Brain Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniocerebral Trauma; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Andi Saptono, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Bambang Parmanto, Ph.D.

  University of Pittsburgh

  STUDY DIRECTOR

• Brad E. Dicianno, M.D.

  University of Pittsburgh

  STUDY DIRECTOR

Central Study Contacts

Zara Ambadar, Ph.D.

CONTACT

412-608-6118; ambadarz@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 30, 2015
• Study Start: October 1, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)