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NCT04877054 · ClinicalTrials.gov registry record · NA
Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease
A NA study, sponsored by Johns Hopkins All Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT04877054 is a NA study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 16 participants.
The verdict
NCT04877054, a NA study, has completed, sponsored by Johns Hopkins All Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
Sickle cell disease (SCD) is a group of inherited blood disorders affecting 100,000 individuals in the United States. SCD often leads to complications, including pain crises and organ damage. Many individuals with SCD require medications (e.g., Hydroxyurea or Endari) that research has demonstrated reduce risk of complications and improve quality of life. Despite the need for strong medication adherence, adolescents and young adults (AYAs; 13-25 years) have the lowest adherence rates compared to other age groups. Efforts to reduce AYA non-adherence risk should include youth in earlier childhood and persist throughout the AYA developmental period, with the goal of maintaining adherence throughout childhood and young adulthood. Motivational Interviewing (MI) has been effective in increasing pediatric and adult medication adherence via in-person or telehealth delivery; however, researchers have yet to empirically evaluate MI for feasibility, acceptability, and/or efficacy in improving pediatric/AYA SCD medication adherence. The proposed feasibility trial will provide preliminary feasibility data for a newly developed MI+education intervention targeting medication adherence for pediatric and adolescents and young adults (AYA) patients who have sickle cell disease. This trial will also evaluate study design feasibility to inform a future randomized controlled trial (RCT). The investigators are interested in delivering the intervention to AYA patients and to parents of younger children who have sickle cell disease because the investigators anticipate that establishing strong adherence in younger childhood could prevent future non-adherence during the AYA developmental period. Participants will include 13-22 year-old patients with sickle cell disease as well as parents of 0-22 year-old patients with sickle cell disease. The investigators will randomize ten families to a 4-session telehealth MI+education intervention and five families to a one-session education-only control
Interventions
- BEHAVIORAL Education only
- BEHAVIORAL Adherence Treatment Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-30 |
| Est. Completion | 2022-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04877054
The ClinicalTrials.gov registry entry for NCT04877054 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins All Children's Hospital, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Education only is the first listed.
NCT04877054 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04877054 about?
NCT04877054 is a clinical study titled "Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease". Sickle cell disease (SCD) is a group of inherited blood disorders affecting 100,000 individuals in the United States. SCD often leads to complications, including pain crises and organ damage. Many individuals with SCD require medications (e.g., Hydroxyurea or Endari) that research has demonstrated r...
What is the current status of trial NCT04877054?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2021-12-30. Estimated completion is 2022-08-01.
What interventions are being tested in trial NCT04877054?
The interventions under investigation include: Education only (BEHAVIORAL), Adherence Treatment Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04877054?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
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