UMIN-CTR Clinical Trial

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
Email	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
Email	shinohar@oita-u.ac.jp

Sponsor
Institute	Oita University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055159