Adherence to Hydroxyurea in Children With Sickle Cell Anemia
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 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: Completed
Sponsored by: Duke University Official(s) and/or principal investigator(s): Courtney D Thornburg, MD, MS, Principal Investigator, Affiliation: Duke University
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 PedsQLâ„¢. 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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: April 2008
Last updated: May 24, 2013
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