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Communicational Program "Trust" to Improve Adherence to Medications

Primary Purpose

Coronary Artery Disease, Myocardial Infarction, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Standard outpatient observation
Communicational program "Trust"
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring Adherence to therapy, Myocardial Infarction, Coronary Artery Disease, Communicational program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Research Institute of CIrculation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard outpatient observation

Communicational program "Trust"

Arm Description

Outpatient management according to Ministry of health standards

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.

Outcomes

Primary Outcome Measures

Medication Adherence
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

Secondary Outcome Measures

Full Information

First Posted
August 29, 2017
Last Updated
August 29, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT03268291
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Infarction, Cardiovascular Diseases
Keywords
Adherence to therapy, Myocardial Infarction, Coronary Artery Disease, Communicational program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard outpatient observation
Arm Type
Active Comparator
Arm Description
Outpatient management according to Ministry of health standards
Arm Title
Communicational program "Trust"
Arm Type
Experimental
Arm Description
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
Other
Intervention Name(s)
Standard outpatient observation
Intervention Description
Outpatient management according to Ministry of health standards
Intervention Type
Behavioral
Intervention Name(s)
Communicational program "Trust"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication Adherence
Description
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
Time Frame
During 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Prokhorikhin
Phone
9137178040
Email
turbogold@list.ru
Facility Information:
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Kretov, MD, PhD
Email
sibvolna2005@yandex.ru
First Name & Middle Initial & Last Name & Degree
Evgeny Kretov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Aleksei Prokhorikhin, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All the data

Learn more about this trial

Communicational Program "Trust" to Improve Adherence to Medications

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