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NCT Number: NCT02592291

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location status: Recruiting

Location contact

Zara Ambadar, Ph.D.

CONTACT

[email protected]

412-608-6118

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. 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

    Self management skill ratings measured at baseline, and 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.

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

    Self ratings on perceived function and satisfaction questionnaire, assessed at baseline, and 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.

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

    Quality of life ratings measured at baseline, and 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.

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

    Scale of Function measured at baseline, and approximately every three months for up to 12 months.

  5. Psychosocial Outcomes- Change of Depressive Symptoms Over time as assessed by Depressive Symptoms questionnaire.

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

    Questionnaire of Depressive symptoms administered at baseline, and approximately every three months for up to 12 months.

  6. Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review

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

    Medical record review of number of wounds, number of urinary tract infections and occurrences of sepsis.

  7. Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.

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

    Medical Record Review and questionnaire on Number of hospitalizations, number of visits to emergency room and urgent care centers.

  8. Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review

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

    Medical Record Review on Length of stay of hospitalizations.

Secondary outcomes

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

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

    Questionnaire to assess participants subjective feelings about the use of the apps. This is for the MHealth group only.

  2. Usage of the system as assessed by questionnaire and record review of the system usage (a built-in function in the system)

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

    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.

  3. Cost of care

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

    Estimated total cost of medical care.

Study contacts

Contact information is provided by the study sponsor or research team.

Zara Ambadar, Ph.D.

CONTACT

[email protected]

412-608-6118

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2015
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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