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RecruitingNCT06919224

Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease

Trial Parameters

ConditionSickle Cell Disease
SponsorOhio State University
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment287
SexALL
Min Age18 Years
Max AgeN/A
Start Date2026-01-13
Completion2031-03
Interventions
mHealth app + booklets

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Brief Summary

In a hybrid type I effectiveness-implementation trial, our three-center research teams aim to examine whether empowering adults with sickle cell disease (SCD) with patient-facing SCD-specific guidelines through an mHealth application with booklets will decrease acute healthcare utilization and be cost-effective over booklets with the guidelines alone. Our team, head will test our hypotheses with the following aims: Aim 1: evaluate the effectiveness of the patient-facing guidelines mHealth app + booklet intervention to decrease acute healthcare utilization (hospitalizations, emergency room visits, and day hospital visits) in adults with SCD over the standard care in a randomized controlled trial, Aim 2: evaluate the implementation outcomes of the mHealth app + booklet using the capability, opportunity, and motivation-behavior (COM-B) and reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) frameworks, and Aim 3: evaluate the cost-effectiveness of patient-facing mHealth app + booklets vs. standard care in adults with SCD. is hybrid effectiveness-implementation trial design, according to the COM-B and RE-AIM frameworks with a mixed-methods approach, will give valuable insights into the effects, facilitators, and barriers to the implementation that will influence the effects of the patient-facing guidelines intervention.

Eligibility Criteria

Inclusion criteria for adults with SCD include 1. receiving care at the SCD clinic for the prior 12 months, 2. has a diagnosis of SCD (Hgb SS, SC, Sβ-thal), 3. able to speak and understand written English, 4. older than 18 years. Inclusion criteria for the providers and staff members are (1) to be involved in participants' clinical care

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