臨床研究等提出・公開システム

Scientific Title	Development of Remote Engagement and Assistance in Modern ICUs (DREAM-ICU)
Public Title	Development of Remote Engagement and Assistance in Modern ICUs (DREAM-ICU)

Contact for Scientific Queries	Name	Yamamoto Tomonori
	Affiliation	Osaka Metropolitan University
	Address	1-4-3 Asahimachi, Abeno-ku, Osaka City
	Telephone	+81-666453993
	E-mail	yamamoto_tomonori@omu.ac.jp
Contact for Public Queries	Name	Yamamoto Tomonori
	Affiliation	Osaka Metropolitan University
	Address	1-4-3 Asahicho, Abenoku, Osaka city
	Telephone	+81-666453993
	E-mail	typhoon0528@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		April. 01, 2025
Actual date of first enrollment
Target sample size		94
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. At the time of consent, aged 18 years or older 2. Mechanical ventilation for 48 hours or more 3. ICU stay of 4 days or longer
	Exclusion Criteria	1. Having a pre-existing severe mental illness 2. Having apparent dementia 3. Clearly having a high severity of illness with a limited life expectancy 4. No visitation permission from the attending physician
	Age Minimum	18age old exceed
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diseases requiring admission to the intensive care unit (ICU)
Intervention(s)		Remote communication group (frequent remote visits and digital ICU diary) and standard visitation group
Health Condition(s) Keyword		ICU
Intervention(s) Keyword		remote communication
Health Condition(s) Code		ICU
Intervention(s) Code		remote communication
Primary Outcome(s)		The incidence or score of PICS and PICS-F
Secondary Outcome(s)		The relationship between the number and duration of visits and PICS/PICS-F, family satisfaction, and the relationship between the number of visits and family satisfaction

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Grants-in-Aid for Scientific Research (KAKENHI)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Osaka Metropolitan University Hospital Clinical Research Review Committee
Address	Abeno Medix 6th Floor, 1-2-7 Asahi-machi, Abeno-ku, Osaka City, Japan, Osaka
Telephone	+81-6-6645-3456
E-Mail	gr-a-knky-crb@omu.ac.jp
Approval Status	Approval
Date of approval	Mar. 05, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none