PLATFORM to Maximize Patient Knowledge of Health Goals After Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Change in the effect of patient health goal and reminder tool on health outcomes
研究概览
简要总结
The goals of this study are two fold: 1) To learn whether a personalized patient health goal and reminder tool helps patients to learn more about their condition and to make changes in behavior and medication taking to reduce the risk of another heart attack. 2) To examine a blood sample to learn how patients are responding to their medications. The study team will enroll approximately 220 patients in the hospital recovering from a heart attack. Half of the patients will receive the educational tools and a copy will be sent to their outpatient provider.
详细描述
The goals of this study are two fold: 1) To evaluate the impact of a personalized patient health goal education and reminder tool on patient adherence to evidence based therapies and subsequent cardiovascular risk factor modification after acute myocardial infarction (AMI); 2) To assess age-related heterogeneity in antiplatelet response among AMI patients. This is a prospective study of ~220 AMI patients, with at least half over age 65 years. Patients will be surveyed with questionnaires (at baseline and 6 months post discharge) and biomarkers (baseline only) to assess the status of their physical function, depression, nutrition, inflammation, and response to antiplatelet therapies. Patients will also be administered a walking test and a grip strength test at baseline. About 1 week after hospital discharge, and again about 3 months after hospital discharge, about half of the patients and their outpatient providers will receive the personalized post-AMI health goal education and reminder tool on patient adherence to evidence-based secondary prevention therapies. Data will be analyzed in aggregate using descriptive statistics. The primary endpoint of interest is a composite measure of adherence at six months to secondary prevention therapies described as the sum of measures received divided by the sum of available opportunities. The secondary endpoint will be analyzed to describe platelet response profiles as a function of age. The study team anticipates the risks for this study to be minimal, since the patient does not receive any investigational therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Patients with either ST-elevation MI (STEMI) or non-ST-elevation MI (NSTEMI) who are on antiplatelet therapy at the time of enrollment.
- •English language literacy and
- •Able to provide written informed consent.
排除标准
- •Patients less than 18 years of age.
- •Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
- •Life expectancy less than 6 months or discharged on hospice care.
- •Patients without at least 1 scheduled outpatient follow-up visit inside the Duke University Affiliated Physicians network.
- •Patients who receive a coronary artery bypass grafting (CABG) during the eligible enrollment hospitalization.
- •Active chronic inflammatory conditions (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis)
结局指标
主要结局
Change in the effect of patient health goal and reminder tool on health outcomes
时间窗: baseline, 6 months
The study team plans to evaluate the impact of a personalized patient health goal education and reminder tool on 6-month clinical and other health outcomes. The measure will be a composite of lab measures (such as blood pressure at goal; BMI at goal), behavior change (physical activity, smoking cessation) and medication use (beta blockers, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin receptor blockers (ARBs), statins if not contraindicated)
Satisfaction and usefulness of education tools
时间窗: 6 months
The study team will ask patients whether they used the education tools in their follow-up physician visits post-AMI; how helpful the tools were; whether they were easy to read and understand; and whether the amount of material presented was appropriate
次要结局
- Age-associated changes that modulate antiplatelet response(index hospitalization (average 3-5 days), 6 months post discharge)
- Age-associated variation in platelet inhibitory response(index hospitalization (average 3-5 days))
- Association between antiplatelet response and subsequent bleeding events(6 months)