Clinical trial NCT02592291: Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions
Official title: Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2015-10-30
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Psychosocial Outcomes-Change of Self Management Skills Over Time as assessed by Self Management Questionnaire
timeFrame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
measure: Psychosocial Outcomes-Change of Perceived Function and Satisfaction Over Time as assessed by Perceived Function and Satisfaction questionnaire.
timeFrame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
measure: Psychosocial Outcomes-Change of Quality of Life Over Time as assessed by Quality of Life questionnaire.
timeFrame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
measure: Psychosocial Outcomes-Change of Function Ratings Over Time as assessed by Function or Physical Independence questionnaire.
timeFrame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
measure: Psychosocial Outcomes- Change of Depressive Symptoms Over time as assessed by Depressive Symptoms questionnaire.
timeFrame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months
measure: Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review
timeFrame: Through study completion, an average of 1 year.
measure: Medical Outcomes-Improvements in Frequency of Health Care Utilization based on Medical Record Review and Questionnaire.
timeFrame: Through study completion, an average of 1 year.
measure: Medical Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Change of Participants' experience using the mHealth system over time as assessed by questionnaire
timeFrame: At baseline and repeated on a schedule (approximately every three months) for up to 12 months)
measure: Usage of the system as assessed by questionnaire and record review of the system usage (a built-in function in the system)
timeFrame: Through study completion, an average of 1 year.
measure: Cost of care
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Andi Saptono, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Bambang Parmanto, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh
name: Brad E. Dicianno, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.