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

NCT03883282 | Completed

• 1 other identifier: TRUST
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Adherence, Patient

Keywords

patient adherence, randomized clinical trials

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

study group

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

Other: Not Provided

control group

\- Patients who have never participated in RCT

Other: Not Provided

Interventions

Not Provided OTHER

Not Provided

control group; study group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients will be taken from the outpatient register PROFILE

You may not qualify if:

• Patients whose life status is defined as "dead"
• Patients who refused to participate in our study

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: May 12, 2019
• Primary Completion: November 12, 2019
• Study Completion: September 1, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)