Sickle Cell Disease Clinical Trial
Official title:
Adherence to Hydroxyurea and Health-related Quality of Life in Patients With Sickle Cell Disease: An Intervention Study Using a Smartphone App (HU-Go)
NCT number | NCT04675645 |
Other study ID # | IRB 2015-761 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2018 |
Est. completion date | July 11, 2020 |
Verified date | July 2021 |
Source | Ann & Robert H Lurie Children's Hospital of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | July 11, 2020 |
Est. primary completion date | July 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Chronic monthly transfusion support - Any hemoglobinopathy other than sickle cell disease |
Country | Name | City | State |
---|---|---|---|
United States | Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Ann & Robert H Lurie Children's Hospital of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achieving feasibility based on the number of participants completed all study procedures within 6 months of study enrollment | Feasibility is defined as having 80% or more of study participants complete the study within 6 months of enrollment | 3 months of study enrollment | |
Secondary | Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items | Numerical value on a scale 0-8 (higher score indicating higher adherence to hydroxyurea) | 3 months of study enrollment | |
Secondary | Adherence to Hydroxyurea using Visual Analogue Scale | Numerical value on a scale 0-100% (higher score indicating higher adherence to hydroxyurea) | 3 months of study enrollment | |
Secondary | Patient satisfaction with the smartphone app intervention (HU-Go) | Customized patient satisfaction questionnaire, numerical value on a scale 0-10 (higher score indicating higher satisfaction with the app) | 3 months of study enrollment | |
Secondary | HRQOL outcomes | Patient reported outcomes measurement information system (PROMIS) measures, numerical value on a scale of 0-100 points, normal average for the general population is 50 with standard deviation of 10 points. Each HRQOL outcome domain score will be reported separately (higher T scores indicating worse pain, fatigue, depression and anxiety, and lower scores indicating worse physical functioning and peer relationships). | 3 months |
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