Trials / Completed
CompletedNCT04675645
Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App
Adherence to Hydroxyurea and Health-related Quality of Life in Patients With Sickle Cell Disease: An Intervention Study Using a Smartphone App (HU-Go)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
- Sex
- All
- Age
- 12 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Aim 1: Identify the needs, desires, concerns, and expectations of AYA patients with SCD and their parents/caregivers that will guide implementation of a mHealth tool, HU-Go, designed to improve adherence to HU. We will conduct semi-structured interviews with patients and their parents/caregivers. Transcripts will be independently coded and thematic analysis will be conducted. Hypothesis 1: AYA patients with SCD and their parents/caregivers will identify specific features, content, and usability requirements of HU-Go. Aim 2: Assess the longitudinal relationship of HU adherence to HRQoL domains, including fatigue and depression. HU adherence will be measured using electronic pill bottles, self-report measures, laboratory markers, and medication possession ratio (MPR). HRQOL will be assessed using PROMIS® measures. Hypothesis 2: Low HU adherence is associated with impairment of HRQoL domains. Aim 3: Conduct a single-arm, pilot study to determine the effect size associated with improvement in HU adherence after using HU-Go for 12 weeks. Adherence will be measured using self-report measures, laboratory markers and MPR. Hypothesis 3: HU-Go will improve HU adherence by at least 20%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | HU-Go app | A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease |
Timeline
- Start date
- 2018-05-15
- Primary completion
- 2020-07-11
- Completion
- 2020-07-11
- First posted
- 2020-12-19
- Last updated
- 2021-07-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04675645. Inclusion in this directory is not an endorsement.