UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of interdisciplinary swallowing care on prevention of aspiration pneumonia, using ultrasound-based observation of swallowing function in community dwelling adults
Title of the study (Brief title)	Effectiveness of ultrasound-based swallowing care on prevention of aspiration pneumonia in community dwelling adults
Region	Japan

Condition
Condition	dysphagia
Classification by specialty	Geriatrics Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effectiveness of interdisciplinary swallowing care on prevention of aspiration pneumonia, using ultrasound-based observation of swallowing function in community dwelling adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	incidence of aspiration pneumonia during research period (16-18 weeks)
Key secondary outcomes	safe oral intake level

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Baseline phase: participants receive the standard swallowing care based on the conventional observation and tests for 4-6 weeks. Intervention phase: participants receive the interdisciplinary swallowing care ultrasound-based observation of swallowing function for 12 weeks.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Person performing oral intake at sitting or reclining position Person who had experienced choking within the last 6 month
Key exclusion criteria	presence of a tracheotomy hole presence of a systemic infection presence of a sever cognitive impairment presence of a psychiatric disease Person whose physicians have determined that they are not eligible for the study
Target sample size	30

Research contact person
Name of lead principal investigator	Hiromi Sanada
Organization	The University of Tokyo, Graduate School of Medicine
Division name	Division of Health Science and Nursing, Department of Gerontological Nursing and Wound Care Management
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	03-5841-3419
Email	hsanada-tky@umin.ac.jp

Public contact
Name of contact person	Mikako Yoshida
Organization	The University of Tokyo, Graduate School of Medicine
Division name	Department of Imaging Nursing Science
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	0358413451
Homepage URL
Email	mokka-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo, Graduate School of Medicine
Institute
Department

Funding Source
Organization	the Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fujita Health University Japanese Red Cross Toyota College of Nursing
Name of secondary funｄer(s)	None

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	訪問看護ステーションフレンズ（北海道） 北美原クリニック（北海道） 藤田学園地域包括ケアセンター訪問看護ステーション（愛知県）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 18 Day
Anticipated trial start date	2018 Year 02 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 05 Day
Last modified on	2018 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040054