The Longitudinal Relationship of Hydroxyurea Adherence Behavior to Health-related Quality of Life, Barriers to Adherence and Habit Formation in Patients With Sickle Cell Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Hydroxyurea adherence rate
研究概览
简要总结
The primary objective of this study is to better understand factors contributing to variations in hydroxyurea (HU) adherence behavior in adolescents and young adults (AYA) with sickle cell disease (SCD). To meet this objective, the researchers will conduct a prospective cohort study to determine the longitudinal relationship between HU adherence and health-related quality of life (HRQOL) overtime among AYA with SCD. The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.
详细描述
Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea, at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. The specific aim for this study is to determine the longitudinal relationship of HU adherence behavior to health-related quality of life, barriers to adherence and habit formation among AYA with SCD.
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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-21 years old
- •Any sickle cell disease genotype
- •On steady state of hydroxyurea for 2 months
- •Own or have access to a smartphone
- •Parents of patients that meet the eligibility criteria and are enrolled in the study will be included
排除标准
- •Patients with recent hospitalizations within the past 7 days
研究组 & 干预措施
HU-Go app intervention arm
Participants will use the HU-Go app intervention arm for 12 months.
干预措施: HU-Go app (Other)
结局指标
主要结局
Hydroxyurea adherence rate
时间窗: 12 months
Adherence rate is defined as number of given HU doses given, as captured by HU-Go app, divided by total number of doses expected during study period.
次要结局
- Physical function score using Patient reported outcomes measurement information system (PROMIS) measure(12 months)
- Depression score using Patient reported outcomes measurement information system (PROMIS) measure(12 months)
- Anxiety score using Patient reported outcomes measurement information system (PROMIS) measure(12 months)
- Peer relationships score using Patient reported outcomes measurement information system (PROMIS) measure(12 months)
- Adherence to Hydroxyurea using PROMIS Medication Adherence Scale (PMAS)(12 months)
- Adherence to Hydroxyurea using Visual Analogue Scale(12 months)
- Pain score using Patient reported outcomes measurement information system (PROMIS) measure(12 months)
- Fatigue score using Patient reported outcomes measurement information system (PROMIS) measure(12 months)
- Codes and themes from qualitative data analysis(12 months)
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