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

Email

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


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name