Adherence to Hydroxyurea and Health-related Quality of Life in Patients With Sickle Cell Disease: An Intervention Study Using a Smartphone App (HU-Go)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Achieving feasibility based on the number of participants completed all study procedures within 6 months of study enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Chronic monthly transfusion support
- •Any hemoglobinopathy other than sickle cell disease
结局指标
主要结局
Achieving feasibility based on the number of participants completed all study procedures within 6 months of study enrollment
时间窗: 3 months of study enrollment
Feasibility is defined as having 80% or more of study participants complete the study within 6 months of enrollment
次要结局
- HRQOL outcomes(3 months)
- Adherence to Hydroxyurea using Visual Analogue Scale(3 months of study enrollment)
- Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items(3 months of study enrollment)
- Patient satisfaction with the smartphone app intervention (HU-Go)(3 months of study enrollment)
研究者
Sherif Badawy, MD
Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant
Ann & Robert H Lurie Children's Hospital of Chicago