Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants:A Study on Behavioral Patterns

Last updated: October 9, 2022
Sponsor: Cui Yimin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Drugs

Treatment

N/A

Clinical Study ID

NCT03670446
2018[173]
  • All Genders

Study Summary

Novel oral anticoagulant drugs (NOACs) are now increasingly used in clinical practice. Although there are outstanding advantages of NOACs, there are also some shortcomings in use. The behavioral pattern of patients using novel oral anticoagulant drugs can directly affect the effect of anticoagulant therapy.

However, at present, there is no study on behavioral patterns of compliance and cognition in patients using NOACs in China. There are few reports on the management outcomes of NOACs anticoagulant therapy as well. Above all, exploring whether pharmacists change behavioral patterns in patients using NOACs is of great significance to improve the effectiveness and safety and to prove the value of pharmacists who provide pharmaceutical care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Outpatients or inpatients with anticoagulation indications of novel oral anticoagulantdrugs (NOACs).
  2. New prescriptions for NOACs, or previous prescriptions for NOACs, not received anyintervention by pharmacists before.
  3. Written informed consent was obtained from patients or their families.

Exclusion

Exclusion Criteria:

  1. Patients who did not use novel oral anticoagulants.
  2. Patients who had received interventions from pharmacists, such as medicationeducation.
  3. Written informed consent was not obtained from patients or their families.

Study Design

Total Participants: 400
Study Start date:
September 01, 2018
Estimated Completion Date:
December 31, 2023

Study Description

The study is a prospective randomized controlled trial. Patients who will use NOACs are prospectively divided into routine group and pharmacist intervention group.

For the intervention group, pharmacists regularly provide telephone and outpatient follow-up combined with patient medication education, establishing database system, telephone reminder, etc. At the 12-week follow-up, behavioral patterns of compliance, self-anxiety, depression status and satisfaction with the pharmacist service will be evaluated in both groups. Pharmacodynamic substitution indicators and endpoints will be collected as well.

Clinical data is designed to be collected from 400 patients, 200 patients each group. Data will be recorded by Epidata dual-track, analyzed by SPSS19.0 software. P<0.05 is considered significant.

Connect with a study center

  • China Rehabilitation Research Center Beijing Boai Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, 100034
    China

    Active - Recruiting

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