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

National Research Center for Preventive Medicine

Status: Completed

Conditions: Adherence, Patient

Treatments: Other: Not Provided

Study type: Observational

Funder types: Other

Identifiers

NCT03883282

TRUST

Details and patient eligibility

About

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).

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 2 patient groups

study group

Description:

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

Treatment:

Other: Not Provided

control group

Description:

- Patients who have never participated in RCT

Treatment:

Other: Not Provided