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

Wake Forest University (WFU)

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Other: Peer Mentoring [PM]; Other: Structured Education Based Transition Program STE

Study type: Interventional

Funder types: Other

Identifiers

NCT03593395

00027706 (Other Grant/Funding Number)

LCI-HEM-SCD-ST3P-UP-001

Details and patient eligibility

About

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)

Full description

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

Enrollment: 291 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups

Program Structured Education Based Transition Program

Active Comparator group

Description:

Program Structured Education Based Transition Program \[STE\]

Treatment:

Other: Structured Education Based Transition Program STE

Structured Education Based Transition Program + Peer Mentoring

Experimental group

Description:

Structured Education Based Transition Program \[STE\] + Peer Mentoring \[PM\]

Treatment:

Other: Structured Education Based Transition Program STE

Other: Peer Mentoring [PM]