Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App

Completed · Not applicable

Conditions studied: Sickle Cell Disease, Sickle B+ Thalassemia, Sickle Beta Zero Thalassemia, Sickle Cell Hemoglobin C

In brief

This project addresses three important research questions. First, adolescents and young adults (AYA) with sickle cell disease (SCD) and their parents/caregivers will be engaged to inform the (1) domains of health-related quality of life (HRQOL) most important to them, (2) frequency at which they are willing to complete them, and (3) other procedures related to the use, uptake and effect of the HU-Go app as a tool to improve hydroxyurea (HU) adherence. Second, this study seeks to utilize novel modern mobile technology using a multi-functional personalized platform to improve adherence to HU and measure HRQOL in youth with SCD, using NIH-endorsed PROMIS® measures, based on a conceptual model with predefined behavioral targets and mediators. Third, we plan to assess HRQOL changes and identify modifiable behavioral strategies that could serve as surrogates or predictors for HU adherence. This real-time feedback might empower self-directed changes in behavior that could improve adherence to HU.

Key facts

Study ID

NCT04675645

Run by

Ann & Robert H Lurie Children's Hospital of Chicago

People needed

33

Starts

2018-05-15

Expected to finish

2020-07-11

Last updated by the study team

2021-07-29

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 12 years old at the time of study enrollment
• Diagnosis of sickle cell disease (hemoglobin SS or SC or S/B 0 thalassemia) confirmed by hemoglobin electrophoresis
• On hydroxyurea
• Own or have access to a smartphone
• Be able to speak and read English

You may not qualify if…

• Chronic monthly transfusion support
• Any hemoglobinopathy other than sickle cell disease

Where it is running

• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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