UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032180 |
|---|---|
| Receipt number | 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 | 2024/03/04 15:37:27 |
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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
nyukiyo@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Fuminori |
| Middle name | |
| Last name | Tanabe |
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
nyukiyo@yamanashi.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Yamanashi
Department of Fundamental and Clinical Nursing
Institute
Department
Personal name
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
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
none
Publication of results
Published
Result
URL related to results and publications
12th Japan Academy of Public Health Nursing Collection of Speeches no URL
Number of participants that the trial has enrolled
84
Results
1)Study for the elderly requiring support and long-term care
Enforcement group
(1)Repetitive Saliva Swallowing Test(RSST)
The intervention improved swallowing frequency.
(2) Cumulative time for the first swallow of the repeated saliva swallow test
The intervention improved RSST.
(3) Oral diadochokinesis
The intervention improved oral diadochokinesis.
Non-enforcement group
no significant changes were observed.
2)Study for nurses
Itemized scores on evaluation form.
There was no significant change.
Results date posted
| 2024 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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
Participant flow
1)Study for the elderly requiring support and long-term care
Out of all facility users, The elderly who fit the selection criteria were selected.
Subsequently, those who met the exclusion criteria were excluded.
The elderly who gave informed consent and their consent were randomly divided into implementation and non-implementation groups.
2)Study for nurses
All nurses working in day-care and short-term residential care facilities were asked to cooperate in the study.
Adverse events
none
Outcome measures
1)Study for the elderly requiring support and long-term care
(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
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036697
