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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ohio State University
Study ID
NCT06919224
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mHealth app + booklets — OTHER
    A mHealth app that has patient facing guidelines and engaging content and a booklet with the guidelines that are made to be patient-facing.

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2032

Study Design

Enrollment
287 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Acute healthcare utilization [ Time Frame: 12 month ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60607
Saraf Santosh
Victor Gordeuk (SUB_INVESTIGATOR)
Washington University St. LouisSt LouisMissouri63130
Allison King
The Ohio State University Medical CenterColumbusOhio43212
Robert Cronin
[email protected]
Vanderbilt UniversityNashvilleTennessee37203
Robert Cronin, MD, MS
[email protected]
6159365097
Michael DeBaun, MD, MPH
[email protected]
(615) 875-3040
Emmanuel Volanakis (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Sickle cell disease
By research site
University of Illinois at Chicago· Chicago, ILWashington University St. Louis· St Louis, MOThe Ohio State University Medical Center· Columbus, OHVanderbilt University· Nashville, TN

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