Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants:A Study on Behavioral Patterns
Primary Purpose
Anticoagulants, Intention, Behavioral Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pharmacists' intervention
Sponsored by
About this trial
This is an interventional other trial for Anticoagulants
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- China Rehabilitation Research Center Beijing Boai HospitalRecruiting
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pharmacists' intervention
Routine therapy
Arm Description
A group of participants assigned to a pharmaceutical intervention
A group of participants assigned to a control (routine therapy)
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03670446
Brief Title
Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants:A Study on Behavioral Patterns
Official Title
Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants:A Study on Behavioral Patterns
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cui Yimin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulants, Intention, Behavioral Symptoms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmacists' intervention
Arm Type
Experimental
Arm Description
A group of participants assigned to a pharmaceutical intervention
Arm Title
Routine therapy
Arm Type
No Intervention
Arm Description
A group of participants assigned to a control (routine therapy)
Intervention Type
Other
Intervention Name(s)
Pharmacists' intervention
Intervention Description
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.
Establish a medical record and remind their follow-up by message, phone every 2 weeks.
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.
Primary Outcome Measure Information:
Title
Medication adherence
Description
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.
Time Frame
12 weeks
Title
Mental status
Description
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.
Time Frame
12 weeks
Title
anti-Xa and IIa activities
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Xiang, Ph.D
Phone
+86 010 66110802
Email
xiangqz@126.com
Facility Information:
Facility Name
China Rehabilitation Research Center Beijing Boai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Li, M.S
Email
crrc_lw@126.com
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Xiang, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants:A Study on Behavioral Patterns
We'll reach out to this number within 24 hrs