NCT06919224

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
70mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Mar 2032

First Submitted

Initial submission to the registry

April 22, 2024

Completed
12 months until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

5.1 years

First QC Date

April 22, 2024

Last Update Submit

March 19, 2026

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Acute healthcare utilization

    The investigators will measure a count of the # ER visits, # of hospitalizations, and # of day hospital visits (infusion center visits)

    12 month

Secondary Outcomes (2)

  • Self-efficacy

    12 months

  • SCD-specific knowledge

    12 months

Study Arms (2)

mHealth app + booklets

ACTIVE COMPARATOR

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

Other: mHealth app + booklets

Standard care

NO INTERVENTION

Group 1 will receive the control arm with standard care

Interventions

mHealth app + bookletsOTHER

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

mHealth app + booklets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

RECRUITING

Washington University St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

The Ohio State University Medical Center

Columbus, Ohio, 43212, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert M Cronin, MD, MS

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert M Cronin, MD, MS

CONTACT

6146889220robert.cronin@osumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 9, 2025

Study Start

January 13, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2032

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)