NCT03268291

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

August 31, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

August 29, 2017

Last Update Submit

August 29, 2017

Conditions

Coronary Artery DiseaseMyocardial InfarctionCardiovascular Diseases

Keywords

Adherence to therapyMyocardial InfarctionCoronary Artery DiseaseCommunicational program

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard outpatient observation

ACTIVE COMPARATOR

Outpatient management according to Ministry of health standards

Other: Standard outpatient observation

Communicational program "Trust"

EXPERIMENTAL

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.

Behavioral: Communicational program "Trust"

Interventions

Standard outpatient observationOTHER

Outpatient management according to Ministry of health standards

Standard outpatient observation
Communicational program "Trust"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.

Communicational program "Trust"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Aleksei Prokhorikhin

CONTACT

9137178040turbogold@list.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

March 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2020

Last Updated

August 31, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

All the data

Shared Documents
STUDY PROTOCOL, CSR

Locations

RU(1)