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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03883282

Acronym

TRUST

Enrollment

200

Registered

2019-03-20

Start date

2019-05-12

Completion date

2021-09-01

Last updated

2021-12-27

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

Conditions

Adherence, Patient

Keywords

patient adherence, randomized clinical trials

Brief summary

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).

Interventions

OTHERNot Provided

Not Provided

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Countries

Russia

Outcome results

None listed

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