NCT06919224 Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease
| NCT ID | NCT06919224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 287 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2031-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 287 participants in total. It began in 2026-01-13 with a primary completion date of 2031-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Robert M Cronin, MD, MS
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06919224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919224 currently recruiting?
Yes, NCT06919224 is actively recruiting participants. Contact the research team at robert.cronin@osumc.edu for enrollment information.
Where is the NCT06919224 trial being conducted?
This trial is being conducted at Chicago, United States, St Louis, United States, Columbus, United States, Nashville, United States.
Who is sponsoring the NCT06919224 clinical trial?
NCT06919224 is sponsored by Ohio State University. The principal investigator is Robert M Cronin, MD, MS at Ohio State University. The trial plans to enroll 287 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.