Recruiting

mHealth & SCD

Sponsor:

Ohio State University

Code:

NCT06919224

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mHealth app + booklets

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT06919224

Start date

Jan 13, 2026

Status verified date

Mar, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

287 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

  • Acute healthcare utilization [ Time Frame: 12 month ]

Central Contacts and Locations

Central contacts

Robert M Cronin, MD, MS

6146889220robert.cronin@osumc.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60607

Washington University St. Louis

Recruiting

St Louis, Missouri, United States, 63130

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Robert Cronin

robert.cronin@osumc.edu

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Robert Cronin, MD, MS

6159365097robert.cronin@vanderbilt.edu

Michael DeBaun, MD, MPH

(615) 875-3040m.debaun@vanderbilt.edu

Principal Investigator:

Emmanuel Volanakis

More Information

Sponsor

Ohio State University

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-03-23.