N/A
Completed N=291
LCI-HEM-SCD-ST3P-UP-001: The Sickle Cell Trevor Thompson Transition Project (ST3P-UP Study)
Source: ClinicalTrials.gov NCT03593395 ↗Enrolled (actual)
291
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Acute Care Visits (Visits Per Year) — 2.46; 2.96 visits per year
Summary
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Care Visits (Visits Per Year) |
2.46; 2.96 | — |
| SECONDARY Overall Rating of Health Care From Adults Sickle Cell Quality of Life Measurement Information System Quality of Care Measure (ASCQ-ME QOC) |
4; 4; 26; 5; 50; 16 | — |
| SECONDARY Pediatric Quality of Life - Sickle Cell Module (PedsQL-SCD Module) for Health-related Quality of Life |
66.5; 63.4; 68.7; 62.4 | — |
| SECONDARY Medical Outcomes Study Social Support Survey (MOS-SSS) Overall Social Support |
76.8; 77.8; 75.3; 80.6 | — |
| SECONDARY Transition Intervention Program Readiness for Transition (TIP-RFT) Scale |
10.4; 8.5; 9.4; 8.0 | — |
| SECONDARY Health Care Transition Feedback Survey Item: How Often Does Your Health Care Provider Explain Things in a Way That is Easy to Understand? |
48; 26; 3; 0 | — |
| SECONDARY Health Care Transition Feedback Survey: How Often do You Schedule Your Own Appointments With Your Health Care Provider? |
16; 8; 35; 18 | — |
| SECONDARY Health Care Transition Feedback Survey: Does Your Health Care Provider Update and Share a Medical Summary With You? |
46; 25; 5; 1 | — |
| SECONDARY Number of Ambulatory Visits Per Year |
5.31; 5.97 | — |
| SECONDARY Number of Visits With Adult Provider |
6.16; 6.23 | — |
| SECONDARY Number of Hospitalization Days |
4.38; 4.57 | — |
| SECONDARY Number of 14-day Readmissions |
0.14; 0.16 | — |
| SECONDARY Number of 30-day Readmissions |
0.25; 0.25 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03593395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.