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

Not Applicable

Not yet recruiting

• Conditions: Sickle Cell Disease

• Registration Number: NCT06919224
• Lead Sponsor: Ohio State University

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.

Detailed Description

The investigators propose a multi-center hybrid type I effectiveness-implementation trial to assess patient-facing evidence-based guidelines through a mHealth application plus (+) booklets in adults with sickle cell disease (SCD). Clinicians' care of SCD is informed by evidence-based guidelines, which can prevent morbidity and mortality. The National Heart, Lung, and Blood Institute (NHLBI) and the American Society of Hematology (ASH) published guidelines for evidence-based management of SCD for healthcare providers. However, patient, provider, or system barriers prohibit adequate reach within and across all three domains, leading to poor guideline adherence. Our prior work demonstrates 1) the patient's lack of knowledge of evidence-based guidelines, 2) the desire for guidelines to be patient-centered, accessible, and actionable in booklets and a mHealth app, 3) the development of patient-facing booklets with the guidelines and 4) the successful pilot of an engaging mHealth app with the guidelines that adults with SCD will use. Promising preliminary data from our multi-center feasibility randomized controlled trial support using a mHealth app + booklets with patient-facing guidelines for reducing acute healthcare utilization in adults with SCD. In the feasibility trial, the investigators screened 74 participants; 91% (67 of 74) agreed to be recruited and randomized to mHealth + booklet vs. booklets alone. A relative risk reduction of 44% occurred in acute healthcare utilization in the mHealth + booklet arm vs. the booklet alone arm. A total of 75% (50 of 67) of the participants agreed to be followed for six months to assess healthcare utilization and surveys of knowledge and patient-reported outcomes. Based on our preliminary trial results indicating a decrease of at least 44% in acute healthcare utilization (a decrease of 1.5 emergency room visits or hospital admissions per year) with mHealth + booklet, the investigators propose a three-center randomized controlled trial to test the following hypothesis: There will be a 44% relative risk reduction of acute healthcare utilization in adults with SCD (n=272), randomly allocated to mHealth app + booklets vs. standard care, defined as general guidance without patient-facing educational materials, for 12 months. The aims of this proposed study are 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. This 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.

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2025-04-02
• Study First Posted: 2025-04-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Study Start: 2025-07
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acute healthcare utilization	12 month	The investigators will measure a count of the # ER visits, # of hospitalizations, and # of day hospital visits (infusion center visits)

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	12 months	sickle cell self-efficacy scale, as described in Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000;38(9):951-63.; Scale is 0-45, higher score is better Scale has no subscales and measures self-efficacy
SCD-specific knowledge	12 months	Knowledge about SCD guidelines. The knowledge part of the measure is a questionnaire that is multiple choice and asks questions about sickle cell disease with one correct answer and 3 incorrect answers. The investigators will sum up the number of correct answers to determine a score.; This is not a scale.

Trial Locations

Locations (4)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Washington University St. Louis; 🇺🇸 Saint Louis, Missouri, United States

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States