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NCT00672789 · ClinicalTrials.gov registry record · NA
Adherence to Hydroxyurea in Children With Sickle Cell Anemia
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT00672789 is a NA study that has completed, run by Duke University. The registered enrollment target is 31 participants.
The verdict
NCT00672789, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
Medication non-adherence is a true public health problem. Despite advancements in the molecular understanding of disease and improvements in therapy, patient health outcomes will not improve unless patients take prescribed medications regularly. Decreasing the gap between efficacious and effective therapy for patients with SCD is an essential research agenda. Hydroxyurea has been shown to be safe and efficacious in children and infants. However, the effectiveness of the prophylaxis depends on adherence to the recommended regimen. Medication adherence in SCD has previously been found to be sub-optimal in patients taking penicillin, desferoxamine, and pain medication. Adherence to HU has been studied to some extent in children with SCD. Based on estimates of adherence in other chronic illness we expect approximately 50% of patients to be \>80% adherent with their HU administration. There is no gold standard for improving adherence to treatment. There have been a few attempts in the SCD population to improve adherence. These include a day camp to promote education about desferoxamine and peer support, a combination of a slide-show about SCD and it complications, weekly phone calls by the clinic social worker and a calendar, and a seven-phase educational program. Given the striking improvements in the peripheral blood smear findings of patients with SCD on HU therapy, with reduction in the numbers of sickled cells, we hypothesize that viewing the peripheral blood smear of patients with poor adherence to HU compared to a blood smear of someone on HU can be used to improve adherence in non-adherent patients. We will conduct a randomized trial between the intervention of regularly showing children and their parents the peripheral blood smear and standard care, including reminders of the importance of compliance and review of complete blood count parameters, including WBC, MCV, and Hgb concentration. The outcome measures will be increase in hemoglobin concentration and %Hb
Interventions
- BEHAVIORAL Blood smear education
- OTHER standard education
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00672789
The ClinicalTrials.gov registry entry for NCT00672789 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Blood smear education is the first listed.
NCT00672789 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00672789 about?
NCT00672789 is a clinical study titled "Adherence to Hydroxyurea in Children With Sickle Cell Anemia". Medication non-adherence is a true public health problem. Despite advancements in the molecular understanding of disease and improvements in therapy, patient health outcomes will not improve unless patients take prescribed medications regularly. Decreasing the gap between efficacious and effective t...
What is the current status of trial NCT00672789?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2008-04. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00672789?
The interventions under investigation include: Blood smear education (BEHAVIORAL), standard education (OTHER).
Who is sponsoring clinical trial NCT00672789?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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