Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 24, 2019
Open Peer Review Period: Sep 24, 2019 - Nov 19, 2019
(currently open for review)
Integration of mHealth into Sickle Cell Disease Care to Increase Hydroxyurea Utilization (mESH) – An Efficacy and Implementation Study
Hydroxyurea therapy prevents disease complications among patients with sickle cell disease (SCD). Despite the evidence for its efficacy and endorsement by the National Health Lung and Blood Institute (NHLBI) evidence-based guidelines, adoption of this therapy is low, both by patients with SCD and their providers. Mobile health (mHealth) applications provide benefit in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescribing among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea use in SCD, nor has the combination of mHealth been assessed at both patient and provider levels.
To increase hydroxyurea utilization through a combined two-level mHealth intervention approach for both patients with SCD and their providers. The goals are to increase adherence to hydroxyurea therapy among patients with SCD and improve hydroxyurea prescribing behavior among providers of patients with SCD.
We will test the efficacy of two mHealth interventions to increase both patients’ and providers’ utilization and knowledge of hydroxyurea within eight clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that addresses memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox) addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared to their adherence at baseline. As secondary objectives, we will 1) examine the change in health-related quality of life, acute disease complications, perceived health literacy and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health, and 2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the RE-AIM framework, and qualitatively evaluate the implementation of both mHealth interventions.
The study is currently enrolling study participants. Recruitment is anticipated to be complete by mid-2021.
If this two-level intervention, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future larger implementation-effectiveness study. Clinical Trial: NCT04080167
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