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

Completed

• Conditions: Adherence, Patient
• Interventions: Other: Not Provided

• Registration Number: NCT03883282
• Lead Sponsor: National Research Center for Preventive Medicine

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-20
• Study Start: 2019-05-12
• Primary Completion: 2019-11-12
• Study Completion: 2021-09-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Not Provided	- Patients who have never participated in RCT
study group	Not Provided	Patients who have been participated in RCT in the period from 2011 to 2018 (study group)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Research Center for Preventive Medicine; 🇷🇺 Moscow, Russian Federation