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. 2023 Oct 24;7(20):6184-6190.
doi: 10.1182/bloodadvances.2023010676.

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD

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A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD

Robert M Cronin et al. Blood Adv. .

Abstract

Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in lay language for individuals or families with SCD has not been evaluated. We conducted a feasibility randomized controlled trial to determine the acceptability of a mobile health (mHealth) app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and reduce hospitalizations. Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled at 2 sickle cell centers between 2018 and 2022. Participants were randomized to receive either an mHealth app + booklet with patient-facing guidelines or a booklet with the guidelines alone. Participants completed surveys at baseline and a final 6-month visit. Approximately 67 of 74 (91%) agreed to participate and were randomized, with 50 of 67 (75%) completing all the study components. All participants who completed the study in the treatment arm used the app. Our results demonstrated high recruitment, retention, and adherence rate for the first randomized trial for an mHealth app with patient-facing guidelines in adults with SCD. This clinical trial was registered at https://www.clinicaltrials.gov/ as #NCT03629678.

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Conflict of interest statement

Conflict-of-interest disclosure: M.R.D. and his institution are the sponsors of 2 externally funded investigator-initiated research projects, and Global Blood Therapeutics will provide funding for these clinical studies but will not be a cosponsor for either study; M.R.D. does not receive any compensation for the conduct of these 2 investigator-initiated observational studies; is a member of the Global Blood Therapeutics advisory board for a proposed randomized controlled trial, for which he receives compensation; is on the steering committee for a Novartis-sponsored phase 2 trial to prevent priapism in men; was a medical adviser for the development of the CTX001 Early Economic Model; provided medical input on the economic model as part of an expert reference group for Vertex/CRISPR CTX001 Early Economic Model in 2020; and provided consultation to the Forma Pharmaceutical Company about SCD from 2021 to 2022. The remaining authors declare no competing financial interests.

Figures

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Graphical abstract
Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials diagram.

References

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