October, 10 2019

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

Locations

8 United States sites

Age

15 to 45 Years

Phase

N/A

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
SCD 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 Type

Interventional

Phase

N/A

Age

15 to 45 Years

Gender

All

Inclusion Criteria

– 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. 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 52 patients target accrual for the site. A max of 30 patients who are
initiating hydroxyurea can be enrolled per site.

Exclusion Criteria

– 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

Interventions

  • Behavioral

Outcome measures

  • Measure of the association between InCharge Health app to patient hydroxyurea adherence

Location

  • University of California San Francisco, Oakland, California, United States, 94609 [Not yet recruiting]
  • Georgia Regents University, Augusta, Georgia, United States, 30912 [Not yet recruiting]
  • University of Illinois, Chicago, Illinois, United States, 60612 [Not yet recruiting]
  • Washington University, Saint Louis, Missouri, United States, 63110 [Not yet recruiting]
  • Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029 [Not yet recruiting]
  • Duke University, Durham, North Carolina, United States, 27710 [Not yet recruiting]
  • Medical University of South Carolina, Charleston, South Carolina, United States, 29425 [Not yet recruiting]
  • St. Jude Children's Research Hospital, Memphis, Tennessee, United States, 38105 [Recruiting]

Contact Research Team

  • Jane Hankins, MD
    866-278-5833

More info

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