Combined impact of cardiovascular polypill treatment and a specific nurse education program on adherence to therapy in patients with ACS: a randomized study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Adherence will be assessed at the coordinating center one year after admission. A combined evaluation of adherence will be conducted using four methods: Morisky Green, Haynes-Sackett, attendance at follow-up visits, and pharmacy medication pick-up. Patients will be considered adherent if they meet the adherence criteria for all four methods used. The assessment of therapeutic adherence will be performed by a nursing team blinded to the patient’s assigned treatment group, to minimize bias
研究概览
简要总结
To evaluate, through a randomized controlled trial, the potential additive impact of prescribing the cardiovascular polypill at hospital discharge combined with the implementation of a nurse-led education program on therapeutic adherence one year after admission, in patients with acute coronary syndrome (ACS)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted for acute coronary syndrome (ACS) at the study centers between September 2024 and September
- •ACS will be defined as chest pain suggestive of ischemia accompanied by electrocardiographic changes indicative of myocardial ischemia (T-wave inversion, ST-segment elevation or depression, new onset left bundle branch block) and/or high-sensitivity troponin elevation above the laboratory reference threshold
排除标准
- •Contraindication to any of the components of the polypill
- •Refusal or inability to provide informed consent
- •Inability to complete clinical follow-up
- •Patients admitted to long-term care facilities or nursing homes at the time of inclusion and/or during the one-year follow-up
结局指标
主要结局
Adherence will be assessed at the coordinating center one year after admission. A combined evaluation of adherence will be conducted using four methods: Morisky Green, Haynes-Sackett, attendance at follow-up visits, and pharmacy medication pick-up. Patients will be considered adherent if they meet the adherence criteria for all four methods used. The assessment of therapeutic adherence will be performed by a nursing team blinded to the patient’s assigned treatment group, to minimize bias
Adherence will be assessed at the coordinating center one year after admission. A combined evaluation of adherence will be conducted using four methods: Morisky Green, Haynes-Sackett, attendance at follow-up visits, and pharmacy medication pick-up. Patients will be considered adherent if they meet the adherence criteria for all four methods used. The assessment of therapeutic adherence will be performed by a nursing team blinded to the patient’s assigned treatment group, to minimize bias
次要结局
- Cognitive status
- Analysis of drug levels
- Control of cardiovascular risk factors
- Quality of life
- Functional capacity for basic activities of daily living (ADLs)
- Ability to perform instrumental activities of daily living (IADLs)
研究者
Elena Calvo Barriuso
Scientific
Fundacion Epic