UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052048 |
|---|---|
| Receipt number | R000059409 |
| Scientific Title | Testing the Effect of Grandchildren's Intervention to Prevent Grandparents' Sarcopenia Dysphagia. |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2024/07/18 18:46:42 |
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Basic information
Public title
Testing the Effect of Grandchildren's Intervention to Prevent Grandparents' Sarcopenia Dysphagia.
Acronym
Testing the Effect of Grandchildren's Intervention to Prevent Grandparents' Sarcopenia Dysphagia.
Scientific Title
Testing the Effect of Grandchildren's Intervention to Prevent Grandparents' Sarcopenia Dysphagia.
Scientific Title:Acronym
Testing the Effect of Grandchildren's Intervention to Prevent Grandparents' Sarcopenia Dysphagia.
Region
| Japan |
Condition
Condition
healthy elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the effectiveness of grandchildren's intervention in preventing sarcopenia dysphagia in grandparents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A. Eating and Swallowing Assessment
1.Eating and Swallowing Function Assessment Tool-10
2.Tongue pressure evaluation
3.Evaluation using ultrasonic echo
4.Opening Strength Rating
B. Self-Efficacy Scale for Health Care
C. Revised PCG Morale Scale
D. Survey on prevention of dysphagia in sarcopenia through grandchildren's intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
(1) Explanation of the importance of prevention
(2) Training for the swallowing organ
(3) Training of the whole body
The implementation status is recorded and the records are reviewed by the grandchildren on a weekly basis.
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
| 65 | years-old | <= |
Age-upper limit
| 105 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The program is open to persons who are able to demonstrate their own free will with full understanding.
1) Over 65 years old.
2) Independent basic activities of daily living.
3) normal cognitive function;
4) Not diagnosed with dysphagia.
Key exclusion criteria
Participants who do not meet the selection criteria
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Keigo |
| Middle name | |
| Last name | Matsubara |
Organization
Kumamoto Health Science University
Division name
Division of Speech-Language-Hearing Therapy, Department of Rehabilitation, Faculty of Health Science
Zip code
861-5533
Address
325 Izumi-cho, Kita-ku, Kumamoto-shi, Kumamoto
TEL
096-275-2111
matubara-ke@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Matsubara |
Organization
Kumamoto Health Science University
Division name
Division of Speech-Language-Hearing Therapy, Department of Rehabilitation, Faculty of Health Science
Zip code
861-5533
Address
325 Izumi-cho, Kita-ku, Kumamoto-shi, Kumamoto
TEL
096-275-2111
Homepage URL
matubara-ke@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Kumamoto Health Science University
Address
325 Izumi-cho, Kita-ku, Kumamoto-shi, Kumamoto
Tel
096-275-2111
matubara-ke@kumamoto-hsu.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059409
