A feasibility randomized controlled trial of a mHealth app vs booklets for patient-facing guidelines.

Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in a 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 mHealth app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and lower hospitalizations. Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled in two sickle cell centers between 2018-2022. Participants were randomized into receiving either a 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 91% (67 of 74) agreed to participate and were randomized, with 75% (50 of 67) 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 a mHealth app with patient-facing guidelines in adults with SCD. This clinical trial is registered on https://clinicaltrials.gov/ with study ID: NCT03629678.