Adherence to Hydroxyurea in Children With Sickle Cell Anemia
Information source: Duke University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Anemia
Intervention: Blood smear education (Behavioral); standard education (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Duke University Overall contact:
Courtney D Thornburg, MD, MS, Phone: 919-684-3401, Email: courtney.thornburg@duke.edu
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
%HbF and increase in perceived QOL. QOL will be measured with age-appropriate and
parent/proxy PedsQL™. Medication adherence will also be monitored throughout the study with
pharmacy prescription refills, physician assessment, and self-report via a visual analogue
scale. Adherence estimates, hemoglobin concentration, %HbF and QOL will be measured at
baseline, 3 months and 6 months.
Clinical Details
Official title: Adherence to Hydroxyurea in Children With Sickle Cell Anemia
Study design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: treatment adherence
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Sickle cell anemia
- on Hydroxyurea for at least six months
- age 2-17. 9 years
Exclusion Criteria:
- none
Locations and Contacts
Courtney D Thornburg, MD, MS, Phone: 919-684-3401, Email: courtney.thornburg@duke.edu
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Courtney D Thornburg, MD, MS, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: April 2011
Last updated: August 15, 2008
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