Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization- mESH Study

About the study

This project proposes to develop, test and evaluate targeted interventions to improve
clinical provider prescribing of and patient adherence to hydroxyurea (HU). Using a
stepped-wedge design, The investigators will test two innovative interventions utilizing
mobile health to address both patients’ and providers’ needs: 1) an mHealth application for
patients (InCharge Health app) that includes multi-component features to address the memory,
motivation, and knowledge barriers to hydroxyurea use, and 2) an mHealth toolbox application
for providers (HU Toolbox app) that addresses clinical knowledge barriers in prescribing and
monitoring hydroxyurea use. These two interventions will be tested through the following
aims:

Aim 1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge
Barriers to Hydroxyurea Use. Primary hypothesis: The investigators hypothesize that among
adolescents and adults with SCD, the adherence to hydroxyurea, as measured by proportion of
daily coverage (PDC), will increase by at least 20% at 24 weeks after receiving the InCharge
Health app, compared to their hydroxyurea adherence at baseline.

Sub-aim 1.a. To examine and assess both patient engagement and behaviors related to use of
the InCharge Health app, the investigators will evaluate consistent use of the app among
enrolled patients, patient satisfaction, and continued use of the app beyond the study
period.

Sub-Aim 1.b. To examine the clinical influence of the use of the InCharge Health app on PDC,
patients’ clinical outcomes, perceived health literacy, health related quality of life, and
perceived self-efficacy between baseline and 24 weeks.

Aim 2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors.

Sub-Aim 2.a. To examine and assess provider engagement and behaviors related to use of the HU
Toolbox, the investigators will evaluate consistent use of the app among enrolled providers,
providers’ satisfaction, and continued use of the app beyond the study period.

Sub-Aim 2.b. To assess the combined effects of the patient and provider mHealth interventions
on hydroxyurea and health care utilization, the investigators will examine if the changes in
hydroxyurea adherence are enhanced by the use of both provider and patient interventions
compared to those not exposed to one or both interventions.

Aim 3. Identify and Evaluate the Barriers and Facilitators to the use of mHealth
Interventions.

Study point of contact

Jane Hankins, MD
866-278-5833
referralinfo@stjude.org

Locations

8 United States sites

Age

15 to 45 Years

Genotypes

Hb SS, Hb SC

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Behavioral

Compensation

Unknown

participation requirements

– Age 15 years up to and including 45 years

– Treated at or affiliated with one of the SCDIC sites

– English speaking

– Confirmed Sickle Cell Disease (SCD) diagnosis. An SCD diagnosis is defined as Hb
fractionation test (e.g., high- performance liquid chromatography or another
technique) that is diagnostic of one the following: Hb SS, Hb SC, Hb Sβ-thalassemia,
Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.

– Willing and cognitively able to give informed consent

– Access to a cellular/mobile smart phone (either Android or IPhone are acceptable)

– Hydroxyurea therapy: Already receiving hydroxyurea therapy: defined as at least one
prior prescription to hydroxyurea in the past 3 months and no plans to escalate the
dose by more than 5 mg/kg/day. Initiating hydroxyurea therapy: defined as at least one
prescription written at the time of study enrollment (the first prescription must be
written on the same day as study enrollment). Patients who initiate hydroxyurea on the
same day of study enrollment will not contribute to the total of 46 patients target
accrual for the site. A max of 30 patients who are initiating hydroxyurea can be
enrolled per site.

participation restrictions

– Current pregnancy

– On a chronic transfusion program in which they receive more than 8 erythrocyte
transfusions in a 12-month period.

– A red blood cell transfusion in the past 60 days

– Currently using another phone application or an online-based tool (e-health tool) to
increase hydroxyurea adherence

Locations

  • Oakland, California, United States, University of California San Francisco, 94609 [Withdrawn]
  • Augusta, Georgia, United States, Georgia Regents University, 30912 [Recruiting]
  • Chicago, Illinois, United States, University of Illinois, 60612 [Recruiting]
  • Saint Louis, Missouri, United States, Washington University, 63110 [Recruiting]
  • New York, New York, United States, Icahn School of Medicine at Mount Sinai, 10029 [Recruiting]
  • Durham, North Carolina, United States, Duke University, 27710 [Recruiting]
  • Charleston, South Carolina, United States, Medical University of South Carolina, 29425 [Recruiting]
  • Memphis, Tennessee, United States, St. Jude Children's Research Hospital, 38105 [Recruiting]
Last updated 2021-05-04