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Communicational Program Trust to Improve Adherence to Medications

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03268291
Enrollment
2000
Registered
2017-08-31
Start date
2017-03-01
Completion date
2020-12-30
Last updated
2017-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Artery Disease, Myocardial Infarction

Keywords

Adherence to therapy, Myocardial Infarction, Coronary Artery Disease, Communicational program

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.

Interventions

OTHERStandard outpatient observation

Outpatient management according to Ministry of health standards

BEHAVIORALCommunicational 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.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Medication AdherenceDuring 1 yearAdherence 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

Countries

Russia

Contacts

Primary ContactAleksei Prokhorikhin
turbogold@list.ru9137178040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026