Study protocol for a randomized controlled trial to assess the feasibility of an open label intervention to improve hydroxyurea adherence in youth with sickle cell disease.
Community health workers (CHW) are increasingly recognized as a strategy to improve health outcomes for the underserved with chronic diseases but has not been formally explored in adolescents with sickle cell disease (SCD). SCD primarily affects African American, Hispanic and other traditionally underserved populations. Hydroxyurea (HU), an oral, once-daily medication, is the only approved therapeutic drug for sickle cell disease and markedly reduces symptoms, morbidity and mortality and improves quality of life largely by increasing hemoglobin F blood levels. This paper presents the rationale, study design and protocol for an open label randomized controlled trial to improve parent-youth partnerships in self-management and medication adherence to HU in adolescents with SCD.



A CHW intervention augmented by text messaging was designed for adolescents with SCD ages 10-18years and their parents to improve daily HU adherence. Thirty adolescent parent dyads will be randomized with 2:1 intervention group allocation. Intervention dyads will establish a relationship with a culturally aligned CHW to identify barriers to HU use, identify cues to build a habit, and develop a dyad partnership to improve daily HU adherence and achieve their individualized "personal best" hemoglobin F target. Intervention feasibility, acceptability and efficacy will be assessed via a 2-site trial. Outcomes of interest are HU adherence, dyad self-management communication, quality of life, and resource use.



Despite known benefits, poor HU adherence is common. If feasible and acceptable, the proposed intervention may improve health of underserved adolescents with SCD by enhancing long-term HU adherence.



NCT02029742.
Columbia University School of Nursing, New York, NY, United States; College of Dental Medicine, Columbia University Medical Center, New York, NY, United States.
Arlene
A
Smaldone
Mailman School of Public Health, New York, NY, United States.
Sally
S
Findley
Columbia University School of Nursing, New York, NY, United States; Department of Biomedical Informatics, Columbia University Medical Center, New York, NY, United States.
Suzanne
S
Bakken
Department of Pediatrics, Columbia University Medical Center, New York, NY, United States; New York Presbyterian Hospital, New York, NY, United States.
L Adriana
LA
Matiz
Department of Pediatrics, Columbia University Medical Center, New York, NY, United States; Department of Psychiatry, Columbia University Medical Center, New York, NY, United States.
Susan L
SL
Rosenthal
Columbia University School of Nursing, New York, NY, United States; Mailman School of Public Health, New York, NY, United States.
Haomiao
H
Jia
Community Health Worker Network of New York City, United States.
Sergio
S
Matos
Department of Pediatrics, Albert Einstein Medical School and Montefiore Hospital, NY, NY, United States.
Deepa
D
Manwani
Department of Pediatrics, Columbia University Medical Center, New York, NY, United States.
Nancy S
NS
Green
D000293:Adolescent; D000755:Anemia, Sickle Cell / Q000188:drug therapy*; D000986:Antisickling Agents / Q000627:therapeutic use*; D002648:Child; D003150:Community Health Workers; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006918:Hydroxyurea / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D009042:Motivation; D060145:Text Messaging
D000986:Antisickling Agents; D006918:Hydroxyurea
Community health worker; Hydroxyurea; Protocol; Randomized trial; Sickle cell anemia; Youth