Community Health Workers and mHealth for Sickle Cell Disease Care
NCT ID: NCT03648710
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
405 participants
INTERVENTIONAL
2019-01-15
2024-08-31
Brief Summary
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Detailed Description
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Self-management support is a key component of the Chronic Care Model. Community health worker (CHW) programs are increasingly popular and have efficacy on chronic disease self-management and system navigation. Mobile health platforms are equally popular, and have efficacy on self-management and adherence. Unfortunately, the effectiveness of mHealth and tailored texting among emerging adults with SCD is still unknown. Furthermore, also unknown is the comparative effectiveness of CHW programs and mHealth.
The purpose of the study is to determine the comparative effectiveness of CHW programs and mHealth among emerging adults with SCD during transition versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with SCD.
The primary objective of this study is to compare the effectiveness of two self-management support interventions (community health workers and mobile health) versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with SCD. The secondary objectives are to:
* Identify and quantify whether patient activation, self-management behaviors, biologic markers, and transfer to adult care are mediators of intervention treatment effects.
* Identify individual and family factors that moderate intervention treatment effects
The exploratory aim is to:
•Explore the association of enhancements to usual care on pediatric and adult acute utilization
The study population will consist of all patients with SCD who are 17 or older and are appropriate for transfer to an adult hematologist within 12 months. Excluded are individuals with an intellectual disability that is severe enough that the individual would not have the capacity to interact with a mobile or web-based program even with assistance or have a conversation with a community health worker (i.e. non-verbal).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Enhanced Usual Care
Enhanced usual care will be standardized across sites with transition/transfer of care checklists that will be used at all sites. Enhanced usual care will minimally include (1) patient seen by the pediatric provider with the parent outside the examination room, (2) a social work consult to screen and address sociodemographic risk factors, (3) information on health insurance adequacy provided to patient, (4) adult hematologist identified, (5) adult primary care provider identified, (6) medical release signed, and (7) medical record viewable or sent to adult provider.
No interventions assigned to this group
Peer Community Health Worker
The CHW program will primarily be modeled after the highly successful IMPaCT Program developed by the Penn Center for Community Health Workers and CHOP's Youth CHW Program for Pediatric to Adult Transitions developed by our research team, which were both developed with high levels of patient input. SCD specific content and expertise from the CHW Program through the Sickle Cell Disease Association of American Philadelphia Delaware Valley Chapter and other published models will be included. Components will include: 1) development of patient-centered goals and individualized action plan around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; and 3) tailored peer support using telephone calls and/or visits
Peer Community Health Worker
Participants will be communicating with their CHWs on a weekly basis, which is consistent with other successful community health worker protocols with published efficacy. Community Health Workers will be peers with sickle cell disease, who have successfully transitioned and are under 30 years of age.
Mobile Health
All participants enrolled in the mHealth arm will download an enhanced version of iManage, which was developed by Co-Investigator Lori Crosby at and adolescents and young adult patients with SCD. Components include: 1) development of patient-centered goals around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; 3) virtual peer support where users can encourage others to complete goals, forms teams, and interact with other youth with SCD; and 4) daily symptom tracking and visual tracking of goal completion. Investigators will add with daily tailored texting.
Mobile Health
A mobile health application created as a resource for young adults transitioning.
Interventions
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Peer Community Health Worker
Participants will be communicating with their CHWs on a weekly basis, which is consistent with other successful community health worker protocols with published efficacy. Community Health Workers will be peers with sickle cell disease, who have successfully transitioned and are under 30 years of age.
Mobile Health
A mobile health application created as a resource for young adults transitioning.
Eligibility Criteria
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Inclusion Criteria
* Have sickle cell disease, defined as those individuals with HbSS, HbSC, HbSβ0Thal, HbSβ+Thal genotypes
* Receive care at a participating pediatric sickle cell disease center.
* Appropriate for transfer to an adult hematologist within 12 months
Exclusion Criteria
17 Years
ALL
Yes
Sponsors
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St. Christopher's Hospital for Children
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Steven and Alexandra Cohen Children's Medical Center
INDIV
Connecticut Children's Medical Center
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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David Rubin, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Sophia Jan, MD
Role: PRINCIPAL_INVESTIGATOR
Cohen's Children Medical Center/Northwell Health
Kim Smith-Whitley, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Connecticut Children's Medical Center
Hartford, Connecticut, United States
Cohen's Children's Medical Center
New Hyde Park, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christophers Hospital for Children
Philadelphia, Pennsylvania, United States
Countries
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References
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Belton TD, Steinway CM, Teng O, Shults J, Barakat LP, Aygun B, Appiah-Kubi A, Crosby LE, Niss O, Andemariam B, Schwartz LA, Luma S, Smith KA, Johnson TB, Rubin DM, Smith-Whitley KM, Jan S. The Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care (COMETS) Trial: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 4;14:e69239. doi: 10.2196/69239.
Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
Other Identifiers
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18-015106
Identifier Type: -
Identifier Source: org_study_id