REHASH: Barriers to Hydroxyurea Adherence for Sickle Cell Disease

Re-Aiming at Hydroxyurea Adherence for Sickle Cell with MHealth

Categories:

Hematological Disorders

Sickle Cell Disease

Diseases Treated:

Sickle cell disease

Eligibility Overview:

This study is limited to patients living in the Memphis, Tennessee region.

Phase I

Phase II

  • Diagnosis of sickle cell disease
  • Between 15 and 44.9 years old
  • Receiving hydroxyurea treatment for sickle cell disease
  • Owns a smart phone
  • Not currently receiving text messages for improving hydroxyurea adherence
  • Not currently undergoing hydroxyurea dose escalation
  • Not on any investigational new drug intervention study for sickle cell disease
  1. Brief Summary

    Current guidelines recommend adults and children at least 9 months old with sickle cell disease (SCD) who experience symptoms be offered hydroxyurea. Research has shown hydroxyurea reduces hospitalizations and mortality, is relatively easy to administer and costs less than $1 a day. Despite overwhelming evidence for positive effects, it is vastly underutilized.

    Health system barriers to hydroxyurea use include insufficient access to SCD-specific care, limited access to medication (due to lack of health coverage) and providers’ reluctance to prescribe it. Patient-level barriers include insufficient knowledge or misperceptions regarding risk and benefits and forgetfulness to take the drug as prescribed.

    This study will examine barriers to hydroxyurea adherence among SCD patients between 15 and 45 years of age by conducting a needs assessment and gathering data to develop and test a smart phone application to encourage adherence. Study participants will be limited to patients living in the Memphis, Tennessee region.

    Primary Objective

    Phase I:

    • To conduct a needs assessment of hydroxyurea utilization barriers and facilitators

    Phase II:

    • To test the feasibility and acceptance of a patient-informed smart phone application to improve hydroxyurea adherence in the Memphis, Tennessee region and to estimate the efficacy parameters needed to design a large Phase III trial

    Eligibility Criteria

    Inclusion criteria include:

    Phase I

    • Diagnosis of sickle cell disease (any genotype)
    • Between 15 and 44.9 years old
    • Speaks English

    Phase II

    • Diagnosis of sickle cell disease (any genotype)
    • Between 15 and 44.9 years old
    • Receiving hydroxyurea treatment for sickle cell disease
    • Owns a smart phone

    Exclusion criteria include:

    Phase II

    • Currently receiving text messages for improving hydroxyurea adherence
    • Currently undergoing hydroxyurea dose escalation
    • Currently on any IND intervention study for sickle cell disease

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    Hydroxyurea is a medicine used to treat sickle cell disease. When taken regularly, it can reduce symptoms, complications and the need to go to the hospital.

    This study will look at hydroxyurea use among teens and adults with sickle cell disease. The study includes two parts: Phase I and Phase II.

    In Phase I, researchers will gather information from patients about the obstacles they face in taking hydroxyurea. This process will include patient surveys, interviews and focus groups.

    In Phase II, researchers will use the information gathered in Phase I to develop a smart phone application (app) for patients.

    Purpose of this clinical trial

    The main goals of this study are to understand the obstacles that prevent patients from taking hydroxyurea, and to find out if a smart phone app can help them remember to take their medicine on time.

    Eligibility overview

    Phase I

    • Diagnosis of sickle cell disease
    • Between 15 and 44.9 years old
    • Speaks English

    Phase II

    • Diagnosis of sickle cell disease (SCD), any genotype
    • Between 15 and 44.9 years old
    • Receiving hydroxyurea treatment for sickle cell disease
    • Owns a smart phone
    • Not currently receiving text messages for improving hydroxyurea adherence
    • Not currently undergoing hydroxyurea dose escalation
    • Not on any investigational new drug (IND) intervention study for sickle cell disease
  3. REHASH Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT03344900
    Trial Start Date December 2017
    Estimated Enrollment 175
    Study Type Observational
    Conditions Sickle cell disease
    Ages 15 to 44 years old
    Principal investigator Jane Hankins, MD, MS
    Study Sites St. Jude Children’s Research Hospital
    For a consultation or to discuss REHASH St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.