Mobile app plus printed booklets to help adults manage sickle cell disease
Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease (PF-Guide)
This project will test whether a mobile app combined with printed patient-facing sickle cell guidelines helps adults with sickle cell disease use less emergency and hospital care than printed booklets alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 287 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 4 sites (Chicago, Illinois and 3 other locations) |
| Trial ID | NCT06919224 on ClinicalTrials.gov |
What this trial studies
This is a multi-center hybrid type I randomized trial comparing a patient-facing mHealth app plus printed guideline booklets versus booklets alone in adults with sickle cell disease. The primary effectiveness outcome is reduction in acute healthcare utilization (hospitalizations, emergency department visits, and day hospital visits). The trial will also measure implementation outcomes using COM-B and RE-AIM frameworks and perform a cost-effectiveness analysis. Participants are adults with documented SCD receiving care at one of three participating centers and able to read English.
Who should consider this trial
Good fit: Adults (18+) with confirmed sickle cell disease (Hb SS, SC, or Sβ-thalassemia) who have received care at a participating SCD clinic for at least the prior 12 months and can read English.
Not a fit: Patients under 18, non-English speakers, those not receiving care at the participating clinics, or those without access to a mobile device or who cannot use the app are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the intervention could lower emergency and hospital visits and reduce healthcare costs by giving patients clear, actionable sickle cell guidance on their mobile devices.
How similar studies have performed: Prior multi-center feasibility work by the team showed promising results, including a reported 44% relative reduction in acute healthcare utilization, but larger randomized evidence is still needed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 3 other locations
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- Washington University St. Louis — St Louis, Missouri, United States (Recruiting)
- The Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Robert M Cronin, MD, MS — Ohio State University
- Study coordinator: Robert M Cronin, MD, MS
- Email: robert.cronin@osumc.edu
- Phone: 6146889220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.