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NCT04080167 · ClinicalTrials.gov registry record · NA
Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization
A NA study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- NA
- Development phase
- 382
- Enrollment target
NCT04080167 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 382 participants.
The verdict
NCT04080167, a NA study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 382 participants
- Enrollment target
Study Summary
This project proposes to develop, test and evaluate targeted interventions to improve clinical provider prescribing of and patient adherence to hydroxyurea (HU). Using a stepped-wedge design, The investigators will test two innovative interventions utilizing mobile health to address both patients' and providers' needs: 1) an mHealth application for patients (InCharge Health app) that includes multi-component features to address the memory, motivation, and knowledge barriers to hydroxyurea use, and 2) an mHealth toolbox application for providers (HU Toolbox app) that addresses clinical knowledge barriers in prescribing and monitoring hydroxyurea use. These two interventions will be tested through the following aims: Aim 1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge Barriers to Hydroxyurea Use. Primary hypothesis: The investigators hypothesize that among adolescents and adults with SCD, the adherence to hydroxyurea, as measured by percentage of days covered (PDC), will increase by at least 20% at 24 weeks after receiving the InCharge Health app, compared to their hydroxyurea adherence at baseline. Sub-aim 1.a. To examine and assess both patient engagement and behaviors related to use of the InCharge Health app, the investigators will evaluate consistent use of the app among enrolled patients, patient satisfaction, and continued use of the app beyond the study period. Sub-Aim 1.b. To examine the clinical influence of the use of the InCharge Health app on PDC, patients' clinical outcomes, perceived health literacy, health related quality of life, and perceived self-efficacy between baseline and 24 weeks. Aim 2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors. Sub-Aim 2.a. To examine and assess provider engagement and behaviors related to use of the HU Toolbox, the investigators will evaluate consistent use of the app among enrolled providers, providers' satisfaction, and continued use of the a
Interventions
- BEHAVIORAL InCharge Health mobile application
- BEHAVIORAL HU Toolbox mobile application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2019-11-11 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04080167
The ClinicalTrials.gov registry entry for NCT04080167 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which InCharge Health mobile application is the first listed.
NCT04080167 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04080167 about?
NCT04080167 is a clinical study titled "Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization". This project proposes to develop, test and evaluate targeted interventions to improve clinical provider prescribing of and patient adherence to hydroxyurea (HU). Using a stepped-wedge design, The investigators will test two innovative interventions utilizing mobile health to address both patients' a...
What is the current status of trial NCT04080167?
This trial is currently completed. It is a NA study. The enrollment target is 382 participants. The study started on 2019-11-11. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04080167?
The interventions under investigation include: InCharge Health mobile application (BEHAVIORAL), HU Toolbox mobile application (BEHAVIORAL).
Who is sponsoring clinical trial NCT04080167?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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