Purpose

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)

Condition

Eligibility

Eligible Ages
Over 16 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Cluster Randomized Parallel group study
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm 1-A
Small sized Program Structured Education Based Transition Program [STE]
  • Other: Structured Education Based Transition Program STE
    Education-based program without Peer Mentoring
Experimental
Arm 1-B
Small sized program Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
  • Other: Peer Mentoring [PM]
    Virtual Peer Mentoring in addition to Structured Education Transition QI
Active Comparator
Arm 2-A
Large sized program Structured Education Based Transition Program [STE]
  • Other: Structured Education Based Transition Program STE
    Education-based program without Peer Mentoring
Experimental
2-B
Large sized program Structured Education Based Transition Program [STE] + Peer Mentoring [PM]
  • Other: Peer Mentoring [PM]
    Virtual Peer Mentoring in addition to Structured Education Transition QI

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Caterina Minniti
cminniti@montefiore.org

More Details

Status
Recruiting
Sponsor
Ifeyinwa (Ify) Osunkwo MD MPH

Study Contact

Shanikwha June
980-442-2044
Shanikwha.June@atriumhealth.org

Detailed 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.