Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor

Study Overview
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Brief Summary
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A prospective non-interventional single-center study aimed to evaluate the influence of participation in international randomized controlled trials (RCT) of cardiovascular patients on their compliance and adherence to medicines' intake and regular visits to the doctor in comparison with those patients, who had never participated in RCT within the outpatient registry PROFILE (prospective, observational study).

Official Title
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Influence of Participation in Randomized Controlled Trials on Cardiovascular Patient's Adherence to Medicines' Intake and regUlar viSits to the docTor

Conditions
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Adherence, Patient

Intervention / Treatment
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* Other: Not Provided


Participation Criteria
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Eligibility Criteria
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Inclusion criterion for study group • All patients of the outpatient register PROFILE who participated in the international randomized clinical trials from 2011 to 2018, (n≈100). Inclusion criterion for control group • Patients of the outpatient register PROFILE, who from 2011 to 2018 were observed in the research center for preventive medicine and never participated in international randomized clinical trials (n≈100). Exclusion criteria for both groups Patients whose life status is defined as dead Patients who refused to participate in our study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>Patients who have been participated in RCT in the period from 2011 to 2018 (study group) | Other: Not Provided<br>* Not Provided<br>|
| control group<br>- Patients who have never participated in RCT | Other: Not Provided<br>* Not Provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of motives of enrollment in a trial and patient's attitude to RCT based on elaborated questionnaires for both groups | The specially designed questionnaire for the study group includes 9 questions. Based on the data obtained, we will be able to draw conclusions about the motives for participating in RCTs, the level of trust towards a doctor, and adherence to treatment after the end of the RCT. The questionnaire for the control group includes 8 questions with 3 possible answers as well. Based on the data obtained, we will determine the level of patient awareness of RCTs and the willingness to participate in the trial in the future. This questionnaire is exploratory, each question is considered individually, which allows us to make a more detailed analysis of various aspects of our study. | on enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient adherence, randomized clinical trials