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

Arlene Smaldone, Sally Findley, Suzanne Bakken, L. Adriana Matiz, Susan L. Rosenthal, Haomiao Jia, Sergio Matos, Deepa G. Manwani, Nancy S. Green

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background: 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. Methods/design: A CHW intervention augmented by text messaging was designed for adolescents with SCD ages 10-18 years 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. Discussion: 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.Trial registration: NCT02029742.

Original languageEnglish (US)
Pages (from-to)134-142
Number of pages9
JournalContemporary Clinical Trials
Volume49
DOIs
StatePublished - Jul 1 2016

Fingerprint

Hydroxyurea
Sickle Cell Anemia
Randomized Controlled Trials
Fetal Hemoglobin
Self Care
Quality of Life
Text Messaging
Self Medication
Medication Adherence
Vulnerable Populations
Hispanic Americans
African Americans
Habits
Cues
Chronic Disease
Parents
Communication
Morbidity
Mortality
Health

Keywords

  • Community health worker
  • Hydroxyurea
  • Protocol
  • Randomized trial
  • Sickle cell anemia
  • Youth

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)

Cite this

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. / Smaldone, Arlene; Findley, Sally; Bakken, Suzanne; Matiz, L. Adriana; Rosenthal, Susan L.; Jia, Haomiao; Matos, Sergio; Manwani, Deepa G.; Green, Nancy S.

In: Contemporary Clinical Trials, Vol. 49, 01.07.2016, p. 134-142.

Research output: Contribution to journalArticle

Smaldone, Arlene ; Findley, Sally ; Bakken, Suzanne ; Matiz, L. Adriana ; Rosenthal, Susan L. ; Jia, Haomiao ; Matos, Sergio ; Manwani, Deepa G. ; Green, Nancy S. / 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. In: Contemporary Clinical Trials. 2016 ; Vol. 49. pp. 134-142.
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