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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2032-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

mHealth app + booklets

Intervention Type 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.

Standard care

Group 1 will receive the control arm with standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

(1) to be involved in participants' clinical care

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No