Actively Recruiting
Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease
Led by Ohio State University · Updated on 2026-03-23
287
Participants Needed
4
Research Sites
319 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
U
University of Illinois at Chicago
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with sickle cell disease receiving care at an SCD clinic for the prior 12 months
- Diagnosis of sickle cell disease (Hgb SS, SC, or Sβ-thalassemia)
- Able to speak and understand written English
- Older than 18 years
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
Actively Recruiting
2
Washington University St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
3
The Ohio State University Medical Center
Columbus, Ohio, United States, 43212
Actively Recruiting
4
Vanderbilt University
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
R
Robert M Cronin, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here