Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03708731 · ClinicalTrials.gov registry record
Exploring Adherence Monitoring in Sickle Cell Disease
A clinical trial of Sickle Cell Disease, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- 36
- Enrollment target
- 1
- Study location
NCT03708731 is a study of Sickle Cell Disease that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 36 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03708731, a study of Sickle Cell Disease, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnecessary increases in medication dosage resulting from erroneous assumption that a patient is non-responsive to treatment (versus non-adherent to the regimen as prescribed). Given the detrimental effects of non-adherence, assessment of and intervention for HU non-adherence is essential to improving health outcomes in the pediatric SCD population. Electronic adherence monitoring is widely considered the "gold standard" in objective adherence measurement. These monitors provide continuous, real- time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays," and "white coat" adherence. Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. The primary purpose of this pilot study is to determine the use of the AdhereTech as a feasible and valid measure of HU adherence in pediatric SCD. Primary Objective Estimate the association between HU adherence as measured by the AdhereTech device to a) caregiver-report, b) youth-report, c) lab values, d) pill- count, and e) Medication Possession Ratio (MPR) adherence measures Secondary Objectives Estimate the rate of consent to the study, the rate of AdhereTech device use, the rate of AdhereTech device failure, and the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2026-09-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03708731
The ClinicalTrials.gov registry entry for NCT03708731 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 0 interventions.
NCT03708731 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT03708731 about?
NCT03708731 is a clinical study titled "Exploring Adherence Monitoring in Sickle Cell Disease". Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnec...
What is the current status of trial NCT03708731?
This trial is currently active not recruiting. The enrollment target is 36 participants. The study started on 2019-03-12. Estimated completion is 2026-09-30.
What conditions does trial NCT03708731 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
Who is sponsoring clinical trial NCT03708731?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03708731 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
RECRUITING · Phase 2
-
Early Life Exposures Among Children With Sickle Cell Disease
RECRUITING · NA
-
Exercise in Child Health
RECRUITING · NA
-
Sickle Cell Children's Exercise Study (SuCCESs)
RECRUITING · NA
-
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
RECRUITING · Phase 1
-
Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Severe β-Hemoglobinopathies
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.