Community Health Workers and mHealth for Sickle Cell Disease Care

NCT03648710 | Completed

• 1 other identifier: 18-015106
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 5

Brief Summary

This study will compare the effectiveness of two self-management support interventions-Community Health Workers (CHW) and mobile health (mHealth)-versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with sickle cell disease (SCD), and identify and quantify mediators and moderators of intervention treatment effects.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Change in Health-Related Quality of Life (HRQOL)

  Health-Related Quality of life will be assessed with the PedsQL Sickle Cell Disease (SCD) Module. The PedsQL Sickle Cell Disease Module is a well-validated for use in adolescents and young adults with chronic disease and use a Likert response scale, with higher scores indicating better HRQOL and lower SCD symptoms and problems. The PedsQL SCD Module is a 43-item that measures nine scales: Pain and Hurt (9 items), Pain Impact (10 items), Pain Management and Control (2 items), Worry I (5 items), Worry II (2 items), Emotions (2 items), Treatment (7 items), Communication I (3 items), and Communication II (3 items).

  Baseline, 6 months, 12months, and 18 months.

Secondary Outcomes (7)

• Sickle cell disease knowledge

  Baseline, 6months, 12 months, 18 months

• Transition Readiness

  Baseline, 6 months, 12 months, 18 months

• Social Support

  Baseline, 6 months, 12 months, 18 months

• Coping skills

  Baseline, 6 months, 12 months, 18 months

• Education and vocational planning

  Baseline, 6 months, 12 months, 18 months

Study Arms (3)

Enhanced Usual Care

NO INTERVENTION

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.

Peer Community Health Worker

EXPERIMENTAL

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

Other: Peer Community Health Worker

Mobile Health

EXPERIMENTAL

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.

Other: Mobile Health

Interventions

Peer Community Health Worker OTHER

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.

Peer Community Health Worker

Mobile Health OTHER

A mobile health application created as a resource for young adults transitioning.

Mobile Health

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age 17 years or older
• 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

You may not qualify if:

• 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). Individuals without access to a mobile device, tablet or computer.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• St. Christopher's Hospital for Children: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Steven and Alexandra Cohen Children's Medical Center: collaborator
• Connecticut Children's Medical Center: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Cohen's Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christophers Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Related Publications (3)

• Jan S, Steinway C, Belton T, Shults J, Bennett L, Teng O, Griffis H, Aygun B, Appiah-Kubi A, Apollonsky N, Boruchov D, Niss O, Schwartz L, Crosby L, Barakat L, Andemariam B, Mulchan SS, Rubin D, Smith-Whitley K. Community Health Worker and Mobile Health Interventions for Quality of Life Among Young Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543571. doi: 10.1001/jamanetworkopen.2025.43571.

  PMID: 41247734 DERIVED

• 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.

  PMID: 40905609 DERIVED

• 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.

  PMID: 39382077 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• David Rubin, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Sophia Jan, MD

  Cohen's Children Medical Center/Northwell Health

  PRINCIPAL INVESTIGATOR

• Kim Smith-Whitley, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 27, 2018
• Study Start: January 15, 2019
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

US (5)