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

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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Key information

Conditions

Adherence, Patient Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not provided

Other

Not Provided

Primary outcomes

Assessment of motives of enrollment in a trial and patient's attitude to RCT based on elaborated questionnaires for both groups

Time frame: on enrollment

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.

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Registry information

Official study title

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

Acronym: TRUST

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2021
First posted: Mar 20, 2019
Registry last updated: Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed