Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI)
      guidelines recommend that hydroxyurea be offered to symptomatic adults and all children with
      sickle cell disease (SCD) (HbSS and HbSβ0-thal genotypes) age ≥9 months. Research has shown
      that hydroxyurea reduces hospitalizations and mortality, supporting its effectiveness outside
      of clinical trials. Hydroxyurea is given as a once-daily oral dose that costs <$1 per day.
      Despite overwhelming evidence for positive effects, hydroxyurea is vastly underutilized.
      Given the relative ease of its administration, low cost, and safety profile, barriers to
      hydroxyurea utilization are primarily constrained to the health system and patient
      determinants. System-level barriers include insufficient access to SCD-specific care, limited
      access to medication (due to lack of health coverage), and providers' reluctance in
      prescribing it; while patient-level barriers include low acceptance (due to insufficient
      knowledge or misconceptions regarding risks and benefits), and forgetfulness leading to poor
      adherence.

      Mobile health (mHealth) refers to the practice of medicine and public health supported by
      mobile devices. Short message service (SMS) text messaging (through cell phones) is a
      widespread means of communication, particularly among adolescents and young adults and is an
      emerging intervention modality to improve medication adherence. Its low cost, simplicity, and
      prevalence allow for relatively easy adoption and dissemination in medical practices.

      This protocol seeks to examine barriers to hydroxyurea adherence among SCD patients between
      15 and 45 years of age who are living in the Memphis region by conducting a needs assessment.
      In addition to examining these barriers, the needs assessment will provide data that will
      inform the development of an mHealth application (e.g. mobile phone application) for
      assisting patients in increasing their medication adherence. The developed mHealth
      intervention will then undergo a pilot trial to test its acceptability, satisfaction, and
      feasibility among 56 patients living with SCD.

        -  To conduct multi-level needs assessment of hydroxyurea utilization barriers and
           facilitators, in Memphis, Tennessee (Phase I).

        -  To test the feasibility and acceptance of a patient-informed smart phone application
           aimed at improving hydroxyurea adherence in the Memphis, Tennessee region, and to
           estimate the efficacy parameters needed to design a definitive large phase III trial
           (Phase II).
    

Detailed description: 
      Data for the needs assessment and pilot trial will be collected from the patients via
      validated surveys, qualitative methods (e.g., interviews and focus groups), and medical
      record abstraction.

      The study will utilize a Hybrid Effectiveness-Implementation design that will blend both a
      new intervention to impact the effectiveness of hydroxyurea, text messaging, and study its
      potential for adoption and dissemination in "real-world" practice settings. In Phase I
      (formative process evaluation), actionable barriers of hydroxyurea adherence in Memphis,
      Tennessee, will be identified. The investigators will begin by conducting a broad evaluation
      of hydroxyurea utilization, impediments and facilitators of hydroxyurea adherence and care
      management in general for patients with SCD. Next, this information will be merged with
      patients' preferences for the content of an mHealth intervention, and test it in a local
      cohort (Phase II). If successful and approved by the Sickle Cell Disease Implementation
      Consortium (SCDIC) executive committee, this intervention will advance to the next phase,
      namely, the dissemination and implementation in a larger geographical area (the other SCDIC
      participating sites in Phase III). We will utilize the RE-AIM framework to evaluate the
      intervention representativeness and impact during all phases.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will reside in the Memphis, Tennessee, area and meet the inclusion criteria.
      
Keywords: mHealth; Medication adherence; Barriers to adherence