Recruiting

Observational Study

Sponsor:

RTI International

Code:

NCT06385886

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linkage Coordinator

Study Details

Brief summary:

The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life?

Conditions

Sickle Cell Disease

Study ID

NCT06385886

Start date

Jun 8, 2023

Status verified date

Jun, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Persons must be >/= 18 years of age
  • Persons must have confirmed SCD
  • Persons not seen by a SCD specialist > 1 year +/- 3 months
  • Literacy in English will be required of the consenting patient or parent/guardian

Exclusion Criteria:

  • Persons < 18 years of age
  • Persons that are unable to provide informed consent and do not have a designated care-giver that can consent on his/her behalf
  • Persons with sickle cell trait (as per hemoglobin electrophoresis)
  • Persons seen by a SCD specialist < 1 year +/1 3 months

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals diagnosed with Sickle Cell Disease (SCD) but not receiving care from an SCD specialist.

Individuals diagnosed with Sickle Cell Disease (SCD) but unaffiliated from SCD specialist care. These individuals will be connected to a linkage coordinator (trained staff) to provide a patient-centered approach to engagement with SCD specialist care.

Interventions

Linkage Coordinator

The Linkage Coordinator (LC) will be the initial contact with unaffiliated SCD patients to establish a relationship, champion preventative services, and support them in engaging with an SCD specialist by helping patients address barriers to care. Study staff will provide initial and ongoing training to the LC to ensure they have adequate support to effectively engage with patients.

Primary outcome measure

  • Identification of unaffiliated patients [ Time Frame: Beginning of enrollment - end of study (up to 5 years) ]
  • Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist [ Time Frame: Beginning of enrollment - end of study (up to 5 years) ]

Central Contacts and Locations

Central contacts

Lisa A Cox, MS

770-407-4908lacox@rti.org

Sara Jacobs, PhD

770-407-4951sjacobs@rti.org

Locations

University of Alabama, Birmingham (UAB)

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Julie Kanter, MD

(205) 934-0435jkanter@uabmc.edu

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Sanjay Shah

602-933-0920sshah2@phoenixchildrens.com

University of California, San Francisco (UCSF)

Recruiting

Oakland, California, United States, 94609

Contacts

Marsha Treadwell, PhD

(510) 428-3356marsha.treadwell@ucsf.edu

Augusta University

Recruiting

Augusta, Georgia, United States, 30901

Contacts

Robert Gibson, PhD

(706) 721-1005rogibson@augusta.edu

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Lewis Hsu, MD, PhD

312-355-5019lewhsu@uic.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ravi Talati

216.444.5437walterk15@ccf.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nadia Ali

215-615-6555nadia.ali.07@gmail.com

University of Tennessee at Memphis

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Ugochi Ogu

901.545.8535uogu@uthsc.edu

University of Texas at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Modupe Idowu

(713) 486-5660Modupe.Idowu@uth.tmc.edu

More Information

Sponsor

RTI International

Last update posted

Jun 22, 2025

Last verified

Jun, 2025

Keywords

  • Sickle Cell Disease Care
  • Unaffiliated patients
  • Linkage Coordinator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by RTI International on 2025-06-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.