LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)



Status:Recruiting
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:16 - Any
Updated:4/6/2019
Start Date:January 18, 2018
End Date:May 2023
Contact:Shanikwha June
Email:Shanikwha.June@atriumhealth.org
Phone:980-442-2044

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LCI-HEM-SCD-ST3P-UP-001: A Comparative Effectiveness Study of Peer Mentoring [PM] Versus Structured Transition Education Based Intervention [STE] for the Management of Care Transitions in Emerging Adults With Sickle Cell Disease (SCD)

This multi-center study will compare the effectiveness of adding virtual peer mentoring (PM)
to a structured education-based (STE) transition program for emerging adults with sickle cell
disease to determine its effect on decreasing the number of acute care visits per year,
improving patient-reported outcomes, and reducing healthcare utilization among emerging
adults with sickle cell disease (EA-SCD)

This is a multi-center, cluster randomized study comparing the effectiveness of adding
virtual peer mentoring (PM) to a structured education-based (STE) transition program based on
the 6 core elements of transition in improving acute care reliance, quality of life and
satisfaction with transition process in emerging adults with sickle cell disease (EA-SCD).
The study will involve a total of 14 large (>80 EA-SCD currently in pediatric care) and
small-scale (≤80 EA-SCD currently in pediatric care) clinical sites, with a 1:1 randomization
at the site level. The study will involve approximately 700 subjects, 120 peer mentors, and
25 advisors. The primary endpoint of this study will be the average number of acute care
visits per year over a minimum of 24 months. Secondary objectives are to compare the
effectiveness of STE+PM versus STE alone at improving patient-reported outcomes and reducing
healthcare utilization among EA-SCD. Enrollment is anticipated to occur over 18-24 months

EA-SCD Eligibility Criteria:

Inclusion Criteria:

- Age 16 and < 25 years at the time of consent AND being cared for in a PEDIATRIC SICKLE
CELL PROGRAM

- Any sickle cell genotype

- Not known to be currently pregnant

- Ability to read and understand the English language

- Subject is planned to be transferred to an adult sickle cell program within 6-12
months of consent

Exclusion Criteria:

- Already receiving one on one peer mentoring as part of a transition program -As
determined by the Investigator, uncontrolled undercurrent medical, psychiatric, or
cognitive condition, or social situation that would limit compliance with study
requirements

- Pregnant, incarcerated, or otherwise unable to attend all study related visits

- Lack of easy access to the technology required to complete study surveys (e.g.,
internet in home setting, public area or at local CBO) or to conduct mentoring
sessions

- Other factors that would cause harm or increase risk to the participant or close
contacts, or preclude the participants adherence with or completion of the study.

Mentor Eligibility Criteria:

- Be an adult living with SCD or a caregiver of an adult living with SCD who has
successfully transitioned to adult care (defined as having had at least 3 visits or a
year of continuous care with an adult sickle cell provider)

- Age 26-35 years

- Readily available access to a computer with internet

- Have completed and passed a background check

- Legally able to work in the United States

- Ability to read and understand the English language

- Endorsed by their healthcare provider as reliable and able to meet the physical,
psychological and cognitive requirements for serving as a mentor

Advisor Eligibility Criteria:

- Be an adult living with SCD or a caregiver of an adult living with SCD who has
successfully transitioned to adult care (defined as having had at least 3 visits or a
year of continuous care with an adult sickle cell provider)

- Age ≥ 36 years

- Readily available access to a computer with internet

- Have completed and passed a background check

- Ability to read and understand the English language

- Endorsed by their healthcare provider as reliable and able to meet the physical,
psychological and cognitive requirements for serving as an advisor
We found this trial at
11
sites
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Atlanta, GA
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Charlotte, North Carolina 28211
Phone: 980-442-9107
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Charlotte, NC
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Charlotte, North Carolina 28210
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Charlotte, NC
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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Greenville, South Carolina 29615
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Greenville, SC
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Louisville, KY
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Richmond, Virginia 23235
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Richmond, VA
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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