Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease
Recruiting now · Not applicable
Conditions studied: Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT06919224
- Run by
- Ohio State University
- People needed
- 287
- Starts
- 2026-01-13
- Expected to finish
- 2032-03-01
- Last updated by the study team
- 2026-03-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Illinois at Chicago — Chicago, Illinois, United States (enrolling)
- Washington University St. Louis — St Louis, Missouri, United States (enrolling)
- The Ohio State University Medical Center — Columbus, Ohio, United States (enrolling)
- Vanderbilt University — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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