RecruitingNot ApplicableNCT06919224

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

Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease (PF-Guide)


Sponsor

Ohio State University

Enrollment

287 participants

Start Date

Jan 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • receiving care at the SCD clinic for the prior 12 months,
  • has a diagnosis of SCD (Hgb SS, SC, Sβ-thal),
  • able to speak and understand written English,
  • older than 18 years.
  • (1) to be involved in participants' clinical care

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Interventions

OTHERmHealth app + booklets

A mHealth app that has patient facing guidelines and engaging content and a booklet with the guidelines that are made to be patient-facing.


Locations(4)

University of Illinois at Chicago

Chicago, Illinois, United States

Washington University St. Louis

St Louis, Missouri, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

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NCT06919224


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