Re-Aiming at Hydroxyurea Adherence for Sickle Cell With mHealth
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 15 - 44 |
| Updated: | 1/2/2019 |
| Start Date: | December 5, 2017 |
| End Date: | December 2021 |
| Contact: | Jane S. Hankins, MD, MS |
| Email: | referralinfo@stjude.org |
| Phone: | 866-278-5833 |
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).
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).
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.
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.
Inclusion Criteria:
- Diagnosis of sickle cell disease (any genotype)
- Between the ages of 15 and 44.9 years
- English-speaking
Exclusion Criteria:
- Inability or unwillingness of research participant or legal guardian/representative to
give written informed consent
We found this trial at
2
sites
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Jane S. Hankins, MD, MS
Phone: 866-278-5833
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