Clarifying Misbeliefs About Hydroxychloroquine (HCQ): Developing an Individualized Decision Aid for Diverse Patients With Lupus (HCQ-IDEAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in proportion of adherent participants
研究概览
简要总结
The purpose of this research study is to collect information from lupus patients about their experience with a tool that informs patients about the benefits vs. harms of a medication such as hydroxychloroquine. The main question it aims to answer is whether the decision-making tool will increase medication adherence.
Participants will be asked to complete questionnaires that assess their understanding of the decision-making tool.
详细描述
This study will be no different from a routine lupus or lupus nephritis clinic visit. During the same visit that a participant routinely does for lupus with their healthcare team, a healthcare team member will discuss the tool that elaborates the benefits vs. risks of lupus medications such as hydroxychloroquine. Participants will complete questionnaires that assesses their understanding of the medication (hydroxychloroquine) before and after they complete the discussion regarding the medication using the tool with the healthcare team member.
Study team members will study the data collected to answer research questions. They will analyze the data and plan better steps improve care quality in lupus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •validated SLE diagnosis
- •no absolute contraindication to HCQ (e.g., retinopathy)
- •prior HCQ therapy for at least 3-6 months
排除标准
- •participants with other autoimmune diseases
- •participants who are not taking HCQ
结局指标
主要结局
Change in proportion of adherent participants
时间窗: Baseline to 6 months
Compare the proportion of adherent patients (Adherence = PDC ≥ 80%) at baseline v 6 months after completing intervention
Change in proportion of adherent participants - blood levels
时间窗: Baseline to 6 months
Compare the proportion of adherent patients through blood levels (Adherence = 500 ng/ml or higher) at baseline v 6 months after completing intervention
Change in medication adherence
时间窗: Baseline to 3 months
Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using the proportion of days covered (PDC). PDC is calculated using prescription refill data (PDC = Sum of days covered/number of days in the observation period)
Change in medication adherence - blood levels
时间窗: Baseline to 3 months
Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using blood levels (adherence = 500 ng/ml or higher)
Change in proportion of adherent participants - participant reported
时间窗: Baseline to 6 months
Compare the proportion of adherent patients (Adherence = 80% prescription refills) at baseline v 6 months after completing intervention
Change in medication adherence - participant reported
时间窗: Baseline to 3 months
Compare mean adherence at baseline and three months after completing the intervention. Mean adherence will be measured using participant self-report (adherence = 80% prescriptions refilled)
次要结局
- Change in decisional conflict scores(Baseline to 6 months)
- Assess participant satisfaction with decision-making tool(Post-intervention, on average 6 months)
- Intervention completion(Duration of study, up to 12 months)