Communicational Program "Trust" to Improve Adherence to Medications

NCT ID: NCT03268291

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Myocardial Infarction Cardiovascular Diseases

Keywords

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Adherence to therapy Myocardial Infarction Coronary Artery Disease Communicational program

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard outpatient observation

Outpatient management according to Ministry of health standards

Group Type ACTIVE_COMPARATOR

Standard outpatient observation

Intervention Type OTHER

Outpatient management according to Ministry of health standards

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.

Group Type EXPERIMENTAL

Communicational program "Trust"

Intervention Type BEHAVIORAL

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.

Interventions

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Standard outpatient observation

Outpatient management according to Ministry of health standards

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Research Institute of CIrculation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Aleksei Prokhorikhin

Role: CONTACT

Phone: 9137178040

Email: [email protected]

Facility Contacts

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Evgeny Kretov, MD, PhD

Role: primary

Other Identifiers

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Call of Trust

Identifier Type: -

Identifier Source: org_study_id