Development, Testing, and Implementation of Virtual Statin Associated Muscle Symptom Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 898
- 试验地点
- 2
- 主要终点
- Number of participants who retry statin therapy
研究概览
简要总结
The goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are:
- Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy?
- Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy?
Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change.
All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •KPCO member
- •Sold a statin from KPCO pharmacy in the previous six months
- •Have a gap of >1.0x the days' supply in refilling their statin
- •Patient who stopped therapy (or delayed filling prescription) due to some perceived side effect
- •Has email address available in kp.org (and therefore has access to a computer with internet)
排除标准
- •Unable to verbalize comprehension of study or impaired decision-making
- •Non-English speaking
- •Limited life expectancy (e.g. hospice or palliative care)
- •Pregnant or planning to become pregnant
- •Patients on Kaiser Permanente's "do not call" list for research will also be excluded.
研究组 & 干预措施
Usual care
Participants randomized to usual care will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions.
Usual Care + Virtual Statin Management (VSM)
Participants randomized to usual care + virtual statin management (VSM) will continue to receive usual care at Kaiser Permanente Colorado as they would under normal, non-study conditions, and they will also be given a link to engage with the VSM website. The VSM website is an educational tool which has four principal components: 1) learning how to distinguish if and when muscle symptoms are caused by the statin; 2) learning the essentials about heart disease, focusing on causes, risk factors, and the crucial role of cholesterol management in prevention; exploring various cholesterol lowering options, including when it makes sense to retry a statin and what options exist beyond statins; and 4) learning to engage in productive discussions with healthcare providers and set effective treatment goals together.
干预措施: Virtual Statin Management (VSM) (Other)
结局指标
主要结局
Number of participants who retry statin therapy
时间窗: 30 days post-enrollment
Measured using pharmacy dispensing records
Number of participants who continue to take statin therapy
时间窗: 6 months post-enrollment
Measured using pharmacy dispensing records
次要结局
- How adherent participants are to prescribed statin therapy(6 months post-enrollment)
研究者
Jordan King
Associate Professor
University of Utah