Clinical trial NCT03268291: Communicational Program "Trust" to Improve Adherence to Medications
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Cardiovascular Diseases
Keywords: Adherence to therapy
Myocardial Infarction
Coronary Artery Disease
Communicational program
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2017-08-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will include 2,000 patients. Patients will be randomized into two groups: standard outpatient observation (n = 1 000), the "Trust" program (n = 1 000).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Recent acute myocardial infarction within the past 2 months
* Successful revascularization via coronary stenting or thrombolysis

Exclusion Criteria:

* Concomitant cardiovascular disorders requiring surgical treatment
* Coronary revascularization via CABG
* Patient refused from participating
* Patient is not available for communication within 2 months

Primary outcomes:
measure: Medication Adherence
timeFrame: During 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References: