NCT06385886

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jun 2023Dec 2027

Study Start

First participant enrolled

June 8, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

4.3 years

First QC Date

June 13, 2023

Last Update Submit

June 19, 2025

Conditions

Keywords

Sickle Cell Disease CareUnaffiliated patientsLinkage Coordinator

Outcome Measures

Primary Outcomes (2)

  • Identification of unaffiliated patients

    Identification of patients through hospital, surveillance, and community-based pathways.

    Beginning of enrollment - end of study (up to 5 years)

  • Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist

    Rate of affiliation of participants previously unaffiliated with SCD-specific care with an SCD specialist who are now connected to a linkage coordinator and an SCD-specific care with SCD specialist.

    Beginning of enrollment - end of study (up to 5 years)

Secondary Outcomes (1)

  • Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites

    After methods are optimized - end of study (up to 5 years)

Study Arms (1)

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.

Behavioral: Linkage Coordinator

Interventions

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with Sickle Celle Disease (SCD) who are unaffiliated from SCD care specialists

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama, Birmingham (UAB)

Birmingham, Alabama, 35233, United States

RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

University of California, San Francisco (UCSF)

Oakland, California, 94609, United States

RECRUITING

Augusta University

Augusta, Georgia, 30901, United States

RECRUITING

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Tennessee at Memphis

Memphis, Tennessee, 38163, United States

RECRUITING

University of Texas at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Julie Kanter, MD

    University of Alabama, Birmingham (UAB)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa A Cox, MS

CONTACT

Sara Jacobs, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

April 26, 2024

Study Start

June 8, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 22, 2025

Record last verified: 2025-06

Locations