Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Prevalence of medication adherence
研究概览
简要总结
Many post Acute Coronary Syndrome(ACS) patients do not take their medications (including aspirin) as prescribed, leading to an increase in mortality. Patients enrolled in this study will be enrolled into one of two groups. Patients in the first group will have their medication adherence measured, but will receive all other care as usual. Patients in the second group will also have their medication adherence measured, but they will receive telephone-delivered problem solving therapy (PST) in addition to their usual care. The two groups will be combined to determine the Minimally Effective Dose (MED) and the Maximally Tolerated Dose (MTD) for adherence to aspirin. The medication adherence of the PST group will improve by 20% (<55% to >75%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Medical eligibility:
- •Patient presenting for staged intervention with positive cardiac history OR
- •Patient with stable CAD who received cardiac admission but does not report chest pain. OR
- •Patient with stable CAD who has had a cardiac admission in the past.
- •Patient is non-adherent to prescribed medication.
- •The following exclusion criteria have been set for either safety concerns or concerns that patients will not be able to complete the protocol:
- •inability to communicate in English or Spanish
- •unwilling to be randomized or to have aspirin in a separate bottle if they use a pill box
- •unavailability for the 1 month period of the study (including being unavailable by phone and/or traveling out of the country)
- •medically unable to receive aspirin (e.g. allergy, contra-indicated, etc)
- •deemed unable to comply with the protocol (either self selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia, and patients with current alcohol or substance abuse.
- •deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours).
- •active psychosis, bipolar disorder, or any overt personality disorder
排除标准
- 未提供
结局指标
主要结局
Prevalence of medication adherence
时间窗: 30 days
次要结局
未报告次要终点
研究者
Karina Davidson
Professor of Medicine in Psychiatry
Columbia University