Impact of Communicational Program "Trust" on Adherence to Medications in Patients With Prior Myocardial Infarction Who Underwent Successful Revascularization by Stenting or Thrombolysis: A Prospective Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Medication Adherence
研究概览
简要总结
The trial was designed in such a way as to show that the proposed program "Trust" increases the proportion of patients who adhere to therapy in the cohort of those with coronary heart disease for two years after successful revascularization by using thrombolytic or stenting of the coronary arteries against the background of myocardial infarction.
详细描述
The "Trust" program includes a set of measures aimed at increasing the level of adherence to therapy in patients with myocardial infarction. Differences in adherence rates between patients enrolled in the program and patients undergoing standard outpatient care will be monitored during the study. The study will be conducted according to the clinical approbation protocol, the principles of good clinical practice (GCP) and regulatory requirements.
The developed program is based on the experience of international research studies and includes the following sections:
- daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
- service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
- questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
Information motivating to remain adherence to the therapy is structured as follows:
A) greeting and presentation, a reminder of the necessity for therapy, with the support of the patient's Trust in prolonging the quality of life by regular use of medications; B) the explanation of the action of the medicine taking into account the peculiarities of ordinary consciousness, warning the patient of the most common mistakes in treatment; C) recommendations for changing lifestyle and explaining their need; D) a reminder of the possibility to contact the attending physician, emotional support and counseling.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Recent acute myocardial infarction within the past 2 months
- •Successful revascularization via coronary stenting or thrombolysis
排除标准
- •Concomitant cardiovascular disorders requiring surgical treatment
- •Coronary revascularization via CABG
- •Patient refused from participating
- •Patient is not available for communication within 2 months
研究组 & 干预措施
Standard outpatient observation
Outpatient management according to Ministry of health standards
干预措施: Standard outpatient observation (Other)
Communicational program "Trust"
The developed program is based on the experience of international research studies and includes the following sections:
- daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials;
- service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators;
- questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services.
干预措施: Communicational program "Trust" (Behavioral)
结局指标
主要结局
Medication Adherence
时间窗: During 1 year
Adherence to every class of prescribed medications: Acetylsalicylic acid, P2Y12 receptor inhibitors, Beta-blockers, ACE inhibitors according to percent of medication taking days. Adherence above 80% will be satisfactory
次要结局
未报告次要终点