AnticoagulantsNCT03670446
Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
A study testing Pharmacists' intervention in people with Anticoagulants and Intention, run by Cui Yimin at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulants, Intention, Behavioral Symptoms
- What is being tested?
- Pharmacists' intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
China Rehabilitation Research Center Beijing Boai Hospital
Beijing, Beijing Municipality, 100000
Wen Li, M.S, crrc_lw@126.com
- Recruiting
Peking University First Hospital
Beijing, 100034
Qian Xiang, Ph.D
About this study
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.
Read the 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.
- Conditions
- Anticoagulants, Intention, Behavioral Symptoms
- Being tested
- Pharmacists' intervention
- Medical subject headings
- Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacists' interventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacists' intervention | Experimental | A group of participants assigned to a pharmaceutical intervention Receives: Other: Pharmacists' intervention |
| Routine therapy | No intervention | A group of participants assigned to a control (routine therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Sep 2018
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670446
- Sponsor's protocol ID
- 2018[173]
- Status last verified
- Oct 2022
- First submitted
- 10 Sep 2018
- Last updated
- 12 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists' Intervention in Patients Using Novel Oral Anticoagulants：A Study on Behavioral Patterns
- ClinicalTrials.gov ID
- NCT03670446
- Acronym / sponsor ID
- 2018[173]
- Conditions
- Anticoagulants, Intention, Behavioral Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacists' intervention | Experimental | Other: Pharmacists' interventionA group of participants assigned to a pharmaceutical intervention |
| Routine therapy | No intervention | –A group of participants assigned to a control (routine therapy) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacists' intervention1. 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. | Other | Pharmacists' intervention |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacists' intervention in people with Anticoagulants and Intention, run by Cui Yimin at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Xiang, Ph.D (+86 010 66110802, xiangqz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.