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

Adherence, Patient Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883282
• Other study ID #: TRUST
• Status: Completed
• Start date: May 12, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2021
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient

Intervention

Other:
• Not Provided
Not Provided

Locations

Country	Name	City	State
Russian Federation	National Research Center for Preventive Medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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