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

Delivering Patient-Facing Evidence-Based Guidelines Through mHealth to Adults With Sickle Cell Disease (PF-Guide)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a mobile health app plus booklets with sickle cell care guidelines can reduce hospital stays and urgent care visits compared with booklets alone. It will also study costs and how well the app is put into use. The study is for adults with sickle cell disease and includes providers and staff involved in their care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults must have received care at a sickle cell disease clinic for the past 12 months.
  • Adults must have sickle cell disease of type Hgb SS, SC, or Sβ-thal (sickle beta-thalassemia).
  • Adults must be able to speak English and understand written English.
  • Adults must be older than 18.
  • Providers and staff must be involved in the participants’ medical care.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility criteria

    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 sites (4)

    IL

    • University of Illinois at Chicago · Chicago, IL 60607Saraf Santosh · Study contactVictor Gordeuk · Sub-investigatorMore trials in Chicago

    MO

    OH

    TN