Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
NCT ID: NCT03670446
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2018-09-01
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Pharmacists' intervention
A group of participants assigned to a pharmaceutical intervention
Pharmacists' intervention
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.
Routine therapy
A group of participants assigned to a control (routine therapy)
No interventions assigned to this group
Interventions
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Pharmacists' intervention
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
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Inclusion Criteria
2. New prescriptions for NOACs, or previous prescriptions for NOACs, not received any intervention by pharmacists before.
3. Written informed consent was obtained from patients or their families.
Exclusion Criteria
2. Patients who had received interventions from pharmacists, such as medication education.
3. Written informed consent was not obtained from patients or their families.
ALL
No
Sponsors
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Cui Yimin
OTHER
Responsible Party
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Cui Yimin
Director of pharmacy，M.D & Ph.D
Locations
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China Rehabilitation Research Center Beijing Boai Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Qian Xiang, Ph.D
Role: primary
Other Identifiers
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2018[173]
Identifier Type: -
Identifier Source: org_study_id
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