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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031132
Receipt No. R000035564
Scientific Title Surveys on Medication Adherence of Anticoagulant Drugs and Investigation for Improvement of Medication Adherence by Educational Program in Non-Valvular Atrial Fibrillation Patients
Date of disclosure of the study information 2018/02/05
Last modified on 2020/03/25

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Basic information
Public title Surveys on Medication Adherence of Anticoagulant Drugs and Investigation for Improvement of Medication Adherence by Educational Program in Non-Valvular Atrial Fibrillation Patients
Acronym SMAAP-AF study
Scientific Title Surveys on Medication Adherence of Anticoagulant Drugs and Investigation for Improvement of Medication Adherence by Educational Program in Non-Valvular Atrial Fibrillation Patients
Scientific Title:Acronym SMAAP-AF study
Region
Japan

Condition
Condition Non-valvular atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure medication adherence to edoxaban (once daily) or apixaban (twice daily) in non-valvular atrial fibrillation (NVAF) patients taking direct oral anticoagulants (DOAC) and to examine the effect of educational intervention on medication adherence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adherence difference estimated by the electronic monitoring device between the observation and intervention periods (each period for 12 weeks)
Key secondary outcomes Adherence estimated by the electronic monitoring device during the observation p3riod (12 weeks)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Educational Program for the DOAC use
Interventions/Control_2 Regular medication instruction
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 NVAF patients in outpatient clinics
2 Patients taking edoxaban or apixaban for more than 4 weeks prior to enrolling in this trial
3 In participating in this study, patients who received written consent
Key exclusion criteria 1 Patients participating in or participating in other clinical trials
2 Patients who are considered difficult to examine medication adherence
3 Patients requiring family member or others supports with medication management
4 Inpatients
5 Patients were pregnant or expecting to become pregnant within the duration of the study
6 Patients judged unsuitable as research subjects by the investigators
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Nobuhisa
Middle name
Last name Hagiwara
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email hagiwara.nobuhisa@twmu.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Shiga
Organization Tokyo Women's Medical University
Division name Cardiology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email shiga.tsuyoshi@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Daiichi-Sankyo
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tokyo Women's Medical University Yachiyo Medical Center
National Hospital Organization Yokohama Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board, Hattori Clinic
Address 1-15-18 Bessho, Hachioji, Tokyo,JAPAN, Tokyo
Tel 03-5919-2052
Email reception-office@hattori-irb.com

Secondary IDs
Secondary IDs YES
Study ID_1 jRCTs031180142
Org. issuing International ID_1 Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京女子医科大学病院(東京都)
東京女子医科大学八千代医療センター(千葉県)
国立病院機構横浜医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 12 Month 22 Day
Date of IRB
2018 Year 02 Month 06 Day
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 04 Day
Last modified on
2020 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035564

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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