臨床研究等提出・公開システム

Japanese

Date of registration	July. 26, 2023
Last modified on	July. 26, 2023
Trial ID	jRCT1052230080

Scientific Title	Impact of the Experience Sharing Feature in the Atrial Fibrillation App on Psychological Burden after Catheter Ablation
Public Title	AF app study

Contact for Scientific Queries	Name	Senoo Keitaro
	Affiliation	Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho kamigyo-ku kyoto-shi
	Telephone	+81-752515111
	E-mail	k-senoo@koto.kpu-m.ac.jp
Contact for Public Queries	Name	Senoo Keitaro
	Affiliation	Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho kamigyo-ku kyoto-shi
	Telephone	+81-752515111
	E-mail	k-senoo@koto.kpu-m.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 01, 2022
Actual date of first enrollment		Nov. 08, 2022
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Age over 20 yo Patients scheduled to undergo catheter ablation treatment for non-valvular atrial fibrillation at Kyoto Prefectural University of Medicine Hospital Patients who have a smartphone and can activate the application at least once a week
	Exclusion Criteria	Patients currently participating or planning to participate in an interventional trial Patients with a confirmed diagnosis of mitral stenosis Patients who are deemed inappropriate by the attending physician or treating physician Patients with low anxiety (STAI state anxiety < 40 points) in the preoperative evaluation
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atrial fibrillation
Intervention(s)		use of smart phone application
Health Condition(s) Keyword		Atrial fibrillation, smartphone app, depression, anxiety, post ablation
Intervention(s) Keyword		Atrial fibrillation, smartphone app, depression, anxiety, post ablation
Primary Outcome(s)		Change in scores of state anxiety items on the STAI-JYZ and scores on the AFQLQ at preoperative and 4 and 8 weeks postoperative in the app-using and non-app-using groups
Secondary Outcome(s)		The success rate of involvement will be evaluated by defining "successful involvement" as the use of the "atrial fibrillation app" function at least once a week during the 4-week preoperative period to the 8-week postoperative period. The influence of the atrial fibrillation app on intervention will be evaluated by assessing the evaluation of the "atrial fibrillation app" and the degree of anxiety about information technology, and the involvement in successful/unsuccessful intervention will be evaluated.

Name of Certified Review Board	Ethical Research Review Board of Kyoto Prefectural University of Medicine
Address	Kyoto-shi kamigyo-ku kawaramachidori hirokouji agaru kajii-cho 465, Kyoto
Telephone	+81-75-251-5337
E-Mail	rinri@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval	Jan. 19, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	Japan