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NCT06919224Recruiting

Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease

Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease (PF-Guide)

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
287 (estimated)
First submitted
22 Apr 2024
Start date
13 Jan 2026
Primary completion date
Mar 2031
Lead sponsor
Ohio State University
NCT number
NCT06919224

What you commit to

  • Study type: Interventional
  • Planned participants: 287
  • From 13 Jan 2026 to the primary completion date, Mar 2031
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.
  • (1) to be involved in participants' clinical care

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Illinois at Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
The Ohio State University Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
Vanderbilt University
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
Washington University St. Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.