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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Patients who have been participated in RCT in the period from 2011 to 2018 (study group) |
| |
| control group | - Patients who have never participated in RCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Not Provided | Other | Not Provided |
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| 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 |
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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
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All patients will be taken from the outpatient register PROFILE
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center for Preventive Medicine | Moscow | 101990 | Russia |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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