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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032180
Receipt No. R000036697
Scientific Title Study on the improvement of oral function in the elderly requiring support and long-term care -Practice of dysphagia nursing by use of simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index-
Date of disclosure of the study information 2018/04/10
Last modified on 2019/04/11

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Basic information
Public title Study on the improvement of oral function in the elderly requiring support and long-term care
-Practice of dysphagia nursing by use of simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index-
Acronym Improvement of oral function in the elderly requiring support and long-term care and quality improvement of dysphagia nursing by use of Kuchi-Kara Taberu Index
Scientific Title Study on the improvement of oral function in the elderly requiring support and long-term care
-Practice of dysphagia nursing by use of simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index-
Scientific Title:Acronym Improvement of oral function in the elderly requiring support and long-term care and quality improvement of dysphagia nursing by use of Kuchi-Kara Taberu Index
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect of nursing practice using simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index on oral function improvement in the elderly requiring support and long-term care who use outpatient nursing care services or short-stay nursing care services facilities.
To examine the effect of the efforts for oral function improvement of the elderly on the quality of dysphagia nursing in nurses who work at outpatient nursing care services or short-stay nursing care services facilities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Study for the elderly requiring support and long-term care
Enforcement group : Oral function improvement program as well as support by the many types of job using simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index
Non-enforcement group: Oral function improvement program only
Evaluation items at the time of start and 3 month later
(1)RSST (Repetitive Saliva Swallowing Test) the number of swallowing for 30 seconds in both groups
(2)Multiplication time of the first, the second, and the third swallowing in RSST in both groups
(3) Oral diadochokinesis in both groups
2)Study for nurses
Investigation at the time of start and 12 months later
Mark of evaluation (5 phases) by modified quality assessment scale for dysphagia nursing in visiting nurses
Key secondary outcomes 1)Study for the elderly requiring support and long-term care
Enforcement group: Oral function improvement program as well as support by the many types of job using simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index
Non-enforcement group: Oral function improvement program only
Evaluation items at the time of start and 3 month later
(1) Bukubuku gargle test score (6 phase) before and after enforcement in both groups
(2) Degree of the dirt of teeth or false teeth before and after enforcement in both groups
(3) Food Intake LEVEL Scale before and after enforcement in both groups
(4) Activities of daily living by functional oral intake scale before and after enforcement in both groups

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Oral Function Improvement Program
Interventions/Control_2 Oral function improvement program as well as support by the many types of job using simplified comprehensive assessment tool for feeding support: Kuchi-Kara Taberu Index
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Study for the elderly requiring support and long-term care
(1)The elderly requiring support and long-term care who are 65 years old or older and use outpatient nursing care services or short-stay nursing care services facilities
(2)Those who got consent to this research
(3)Those who understand instruction, can answer questions, and can talk.
(4)Those who can continue efforts to improve oral function, and can answer the evaluation items
2)Study for nurses
Nurses who works at short-stay nursing care services
Key exclusion criteria 1)Study for the Elderly Requiring Support and Long-term Care
(1)Those who will not be able to continue efforts to improve oral function for 3 months.
(2)Those who cannot understand the instruction, cannot answer questions and cannot talk.
(3)Those who have severe dementia and cannot understand instructions.
(4) Those who have severe dysphagia.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Yukiyo
Middle name
Last name Nakagomi
Organization Faculty of Medicine, University of Yamanashi
Division name Department of Fundamental and Clinical Nursing
Zip code 409-3898
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL 055-273-1111
Email nyukiyo@yamanashi.ac.jp

Public contact
Name of contact person
1st name Yukiyo
Middle name
Last name Nakagomi
Organization Faculty of Medicine, University of Yamanashi
Division name Department of Fundamental and Clinical Nursing
Zip code 409-3898
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL 055-273-1111
Homepage URL
Email nyukiyo@yamanashi.ac.jp

Sponsor
Institute Faculty of Medicine, University of Yamanashi
Department of Fundamental and Clinical Nursing
Institute
Department

Funding Source
Organization Faculty of Medicine, University of Yamanashi
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee, Faculty of Medicine, University of Yamanashi
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
Tel 055-273-1111
Email rec-med@yamanashi.ac.jp

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 社会福祉法人 やまなし勤労者福祉会 共立介護福祉センター  たから(山梨県)
社会福祉法人 やまなし勤労者福祉会 共立介護福祉センター ももその(山梨県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 10 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
2017 Year 08 Month 01 Day
Anticipated trial start date
2018 Year 01 Month 13 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 10 Day
Last modified on
2019 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036697

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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