Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease
Recruiting · NCT06919224 · Interventional (participants receive a specific treatment) · Lead sponsor: Ohio State University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- for adults with SCD include
- 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.
- Inclusion criteria for the providers and staff members are
- to be involved in participants' clinical care
Where it is running
4 locations listed across 4 US states.
- 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