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

NCT ID: NCT03883282

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-12

Study Completion Date

2021-09-01

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).

Detailed Description

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Conditions

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Adherence, Patient

Keywords

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patient adherence, randomized clinical trials

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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study group

Patients who have been participated in RCT in the period from 2011 to 2018 (study group)

Not Provided

Intervention Type OTHER

Not Provided

control group

\- Patients who have never participated in RCT

Not Provided

Intervention Type OTHER

Not Provided

Interventions

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Not Provided

Not Provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

• 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

* Patients whose life status is defined as "dead"
* Patients who refused to participate in our study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Research Center for Preventive Medicine

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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TRUST

Identifier Type: -

Identifier Source: org_study_id