UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035140
Receipt No. R000040054
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
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.