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

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ClinicalTrials.gov Identifier: NCT03670446
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anticoagulants Intention Behavioral Symptoms Other: Pharmacists' intervention Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pharmacists' intervention
A group of participants assigned to a pharmaceutical intervention
 Other: 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.
No Intervention: Routine therapy
A group of participants assigned to a control (routine therapy)


Outcome Measures
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Primary Outcome Measures :
  1. Medication adherence [ Time Frame: 12 weeks ]
    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.

  2. Mental status [ Time Frame: 12 weeks ]

    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.


  3. anti-Xa and IIa activities [ Time Frame: 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients admitted to the department of cardiology or outpatients confirmed diagnosis of atrial fibrillation.
  2. New prescriptions for novel oral anticoagulant drugs, or previous prescriptions for oral anticoagulant drugs, not received any intervention by pharmacists before,
  3. Written informed consent was obtained from patients or their families.

Exclusion Criteria:

  1. Patients who did not use novel oral anticoagulants.
  2. Patients who had received interventions from pharmacists, such as medication education.
  3. Written informed consent was not obtained from patients or their families.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670446


Contacts
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Contact: Qian Xiang, Ph.D +86 010 66110802 xiangqz@126.com

Locations
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China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Qian Xiang, Ph.D         
Sponsors and Collaborators
Cui Yimin
More Information
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Responsible Party: Cui Yimin, Director of pharmacy，M.D & Ph.D, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03670446    
Other Study ID Numbers: 2018[173]
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms