UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048501 |
|---|---|
| Receipt number | R000055159 |
| Scientific Title | Screening Patients with Potential Atrial Fibrillation(AF) and Investigating Behavior Change Using IoT |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/07/26 19:27:50 |
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Basic information
Public title
Screening Patients with Potential Atrial Fibrillation(AF) and Investigating Behavior Change Using IoT
Acronym
Screening Patients with Potential Atrial Fibrillation(AF) and Investigating Behavior Change Using IoT
Scientific Title
Screening Patients with Potential Atrial Fibrillation(AF) and Investigating Behavior Change Using IoT
Scientific Title:Acronym
Screening Patients with Potential Atrial Fibrillation(AF) and Investigating Behavior Change Using IoT
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence of all (prevalent and paroxysmal) undiagnosed AF in a Japanese population for high risk of stroke.
Basic objectives2
Others
Basic objectives -Others
To evaluate pre-symptomatic group using the application to improve their lifestyle.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate of prevalence of all (prevalent and paroxysmal) undiagnosed atrial fibrillation (AF) in a Japanese population with high risk for stroke.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Lifestyle improvement using a smartphone application
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons in possession of a smart phone
Key exclusion criteria
Patients with atrial fibrillation or a history of atrial fibrillation
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Takahashi |
Organization
Oita University
Division name
Department of Cardiology and Clinical Examination, Faculty of Medicine
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yuhu, Oita
TEL
097-549-4411
takanao@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuji |
| Middle name | |
| Last name | Shinohara |
Organization
Oita University
Division name
Department of Cardiology and Clinical Examination, Faculty of Medicine
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yuhu, Oita
TEL
097-549-4411
Homepage URL
shinohar@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
Address
1-1 Idaigaoka, Hasama-machi, Yuhu, Oita
Tel
0975866166
rinken@oita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2022 | Year | 07 | Month | 28 | Day |
Last modified on
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055159
