Communicational Program "Trust" to Improve Adherence to Medications

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03268291
• Other study ID #: Call of Trust
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2017
• Last updated: August 29, 2017
• Start date: March 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Aleksei Prokhorikhin
• Phone: 9137178040
• Email: turbogold[@]list.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• Standard outpatient observation
Outpatient management according to Ministry of health standards

Behavioral:
• 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.

Locations

Country	Name	City	State
Russian Federation	State Research Institute of CIrculation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During 1 year