Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
1 other identifier
interventional
400
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 12, 2022
October 1, 2022
5.2 years
September 10, 2018
October 9, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Medication adherence
The Morisky, Green, and Levine Adherence Scale (MGLS) was used to evaluate the medication compliance of dabigatran etexilate and rivaroxaban during treatment. According to the scores of MGLS, compliance was divided into three groups: A score of 0 indicated high compliance; a score of 1 or 2 illustrated intermediate compliance; and a score of 3 or 4 indicated low compliance.
12 weeks
Mental status
Mental status is assessed by Self-rating Depression Scale (SDS) and Self-rating Anxiety Scale (SAS). The threshold value of depression assessment was 53, the higher the score, the more obvious the tendency of depression. 53-62 is defined as mild depression, 63-72 for moderate depression, 72 points above for severe depression. The standard score of SAS was 50, of which 50-59 is mild anxiety, 60-69 is moderate anxiety and 69 is severe anxiety. The patient's awareness of medication is assessed by a self-designed awareness questionnaire.
12 weeks
anti-Xa and IIa activities
Anti-Xa/IIa activity test is divided into peak concentration and valley concentration detection; peak concentration is 100 ng/ml as the critical value, Valley concentration is 50 ng/ml as the limit, divided into better or poor pharmacodynamic indicators. patients with peak concentration \> 100 ng/ml or valley concentration \> 50 ng/ml are defined as better pharmacodynamic indicators.
12 weeks
Study Arms (2)
Pharmacists' intervention
EXPERIMENTALA group of participants assigned to a pharmaceutical intervention
Routine therapy
NO INTERVENTIONA group of participants assigned to a control (routine therapy)
Interventions
1. Medication education: When the patient is enrolled in the intervention group, pharmacists issue an education manual to give a medical education which contains the reasons for using NOACs, the characteristics of the drug, the precautions, and how to monitor the efficacy. Pharmacists re-educate through telephone or clinic during follow-up. 2. Establish a medical record and remind their follow-up by message, phone every 2 weeks. 3. Follow-up in the 4th week and 8th week : Pharmacists recommend patients for drug therapy optimization after conducting a full pharmacotherapy review of each patient's medication regimen and remind them to test urinary occult blood every 1-3 months, detect hemoglobin and liver/kidney function every 3-6 months.
Eligibility Criteria
You may qualify if:
- Outpatients or inpatients with anticoagulation indications of novel oral anticoagulant drugs (NOACs).
- New prescriptions for NOACs, or previous prescriptions for NOACs, not received any intervention by pharmacists before.
- Written informed consent was obtained from patients or their families.
You may not qualify if:
- Patients who did not use novel oral anticoagulants.
- Patients who had received interventions from pharmacists, such as medication education.
- Written informed consent was not obtained from patients or their families.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cui Yiminlead
Study Sites (2)
China Rehabilitation Research Center Beijing Boai Hospital
Beijing, Beijing Municipality, 100000, China
Peking University First Hospital
Beijing, 100034, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of pharmacy，M.D & Ph.D
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 13, 2018
Study Start
September 1, 2018
Primary Completion
October 31, 2023
Study Completion
December 31, 2023
Last Updated
October 12, 2022
Record last verified: 2022-10