Coronary Artery Disease Clinical Trial
Official title:
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
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.
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.
The establishment of an information and counseling center will allow the patient to be
supported throughout the time when the likelihood of giving up therapy and the risk of
complications due to failure are most likely.
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