Adherence to Hydroxyurea in Children With Sickle Cell Anemia

Status Completed

Clinical Trial 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 Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00672789
Study type	Interventional
Source	Duke University
Contact
Status	Completed
Phase	N/A
Start date	April 2008
Completion date	November 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT04581356` - Voxelotor Sickle Cell Exercise Study	Phase 4
Completed	`NCT02712346` - The Role of Endothelin-1 in Sickle Cell Disease	Phase 1
Withdrawn	`NCT02162225` - Study of Beet Juice for Patients With Sickle Cell Anemia	Phase 2
Completed	`NCT01976416` - Novel Use Of Hydroxyurea in an African Region With Malaria	Phase 3
Completed	`NCT01137721` - State Of The Art Functional Imaging In Sickle Cell Disease
Terminated	`NCT01350232` - Treatment of Sickle Cell Anemia With Stem Cell Transplant	N/A
Withdrawn	`NCT00937144` - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil	Phase 4
Completed	`NCT00512564` - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia	N/A
Completed	`NCT00512226` - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia	N/A
Completed	`NCT00004143` - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes	Phase 2
Completed	`NCT00004412` - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Phase 2
Withdrawn	`NCT01925001` - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis	Phase 2
Completed	`NCT01848691` - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis	N/A
Completed	`NCT01783990` - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed	`NCT00874172` - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy	N/A
Completed	`NCT01000155` - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease	Phase 2
Completed	`NCT00399074` - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia	Phase 3
Completed	`NCT00236093` - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain	Phase 2
Completed	`NCT00004492` - Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia	Phase 1/Phase 2