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

• ClinicalTrials.gov Identifier: NCT02592291
• Recruitment Status: Recruiting
• First Posted: October 30, 2015
• Last Update Posted: September 8, 2022
• Sponsor: University of Pittsburgh
• Collaborator: Department of Health and Human Services
• Information provided by (Responsible Party): Andi Saptono, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Cerebral Palsy; Spinal Dysraphism; Brain Injuries; Spina Bifida; Traumatic Brain Injury	Device: MHealth	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions (Component 3)
• Study Start Date: October 2015
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: September 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

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)

Contacts and Locations

Contacts

Contact: Zara Ambadar, Ph.D.; 412-608-6118; ambadarz@upmc.edu

Locations

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contact: Zara Ambadar, Ph.D. 412-608-6118 ambadarz@upmc.edu

Sponsors and Collaborators

University of Pittsburgh

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Andi Saptono, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02592291
• Other Study ID Numbers: MHealth-Comp3
• First Posted: October 30, 2015
• Last Update Posted: September 8, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Andi Saptono, University of Pittsburgh:

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

Additional relevant MeSH terms:

Brain Injuries; Spinal Cord Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Spinal Dysraphism; Neural Tube Defects; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Damage, Chronic; Nervous System Malformations; Congenital Abnormalities