UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035140 |
|---|---|
| Receipt number | R000040054 |
| Scientific Title | 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 12:44:44 |
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Basic information
Public title
Effectiveness of interdisciplinary swallowing care on prevention of aspiration pneumonia, using ultrasound-based observation of swallowing function in community dwelling adults
Acronym
Effectiveness of ultrasound-based swallowing care on prevention of aspiration pneumonia in community dwelling adults
Scientific Title
Effectiveness of interdisciplinary swallowing care on prevention of aspiration pneumonia, using ultrasound-based observation of swallowing function in community dwelling adults
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | 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
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL
03-5841-3419
hsanada-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikako Yoshida |
Organization
The University of Tokyo, Graduate School of Medicine
Division name
Department of Imaging Nursing Science
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL
0358413451
Homepage URL
mokka-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo, Graduate School of Medicine
Institute
Department
Personal name
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
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.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 |
