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)

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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]
• 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]
• 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]
• 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]
• 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]
• Medical Outcomes-Improvements in Preventable Conditions based on Medical Record Review [Time frame: Through study completion, an average of 1 year.]
• 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 Outcomes-Improvements in Length of Health Care Utilization based on Medical Record Review [Time frame: Through study completion, an average of 1 year.]

Secondary outcome measures (3)

• 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)]
• 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.]
• Cost of care [Time frame: Through study completion, an average of 1 year.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Pittsburgh — Pittsburgh

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. PMID 31464189

Identifiers

NCT: NCT02592291 · STUDY19040337

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗