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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Missouri
Washington University St. Louis
RECRUITING
St Louis
Ohio
The Ohio State University Medical Center
RECRUITING
Columbus
Tennessee
Vanderbilt University
RECRUITING
Nashville
Contact Information
Primary
Robert M Cronin, MD, MS
robert.cronin@osumc.edu
6146889220
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2032-03
Participants
Target number of participants: 287
Treatments
Active_comparator: mHealth app + booklets
A mHealth app that has patient facing guidelines and engaging content and a booklet with the guidelines that are made to be patient-facing.
No_intervention: Standard care
Group 1 will receive the control arm with standard care
Sponsors
Collaborators: Washington University School of Medicine, Vanderbilt University Medical Center, University of Illinois at Chicago
Leads: Ohio State University

This content was sourced from clinicaltrials.gov

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