UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063250 |
|---|---|
| Receipt number | R000072334 |
| Scientific Title | An Intervention Study to Reduce the Caregiving Burden on Families of Individuals with Dysphagia and Ensure the Sustainability of Care: Peer Support and Cooking Classes for Dysphagia-Adjusted Meals (Pilot Study) |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/10/13 10:24:45 |
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Basic information
Public title
An Intervention Study to Reduce the Caregiving Burden on Families of Individuals with Dysphagia and Ensure the Sustainability of Care: Peer Support and Cooking Classes for Dysphagia-Adjusted Meals (Pilot Study)
Acronym
An Intervention Study to Reduce the Caregiving Burden on Families of Individuals with Dysphagia
Scientific Title
An Intervention Study to Reduce the Caregiving Burden on Families of Individuals with Dysphagia and Ensure the Sustainability of Care: Peer Support and Cooking Classes for Dysphagia-Adjusted Meals (Pilot Study)
Scientific Title:Acronym
Intervention Study to Reduce the Caregiving Burden on Families of Individuals with Dysphagia and Ensure the Sustainability of Care
Region
| Japan |
Condition
Condition
Not Applicable (Caregivers)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a pilot intervention program -- combining peer support meetings with cooking classes for dysphagia-adjusted meals -- targeted at family caregivers providing home care to individuals with dysphagia, with the aim of clarifying the following points:
1.Whether the intervention program aligns with the types of support sought by caregivers:usefulness, satisfaction, practicality, etc.
2.Changes in perceived caregiving burden and health-related quality of life (QOL) before and after the intervention
3.Caregivers' needs and operational challenges in preparation for conducting a full-scale intervention study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Caregiver Analysis of Reported Experiences with Swallowing Disorders: CARES Japanese version(CARES-J) burden score
Key secondary outcomes
MCS:Mental Component Summary of SF36v2 Japanese version
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
An intervention program that combines peer support gatherings, where family caregivers share experiences and receive emotional support, with cooking classes where participants learn simple methods for preparing texture-modified foods
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Family caregivers who care for individuals with dysphagia at home
(2)Individuals who meet any of the following criteria
(a) Individuals who responded to the questionnaire for a previous study (Grant-in-Aid for Young Scientists, 22K17627) and have agreed to be contacted again by the researchers
(b) Individuals who saw the research information (flyers or posters) distributed or displayed at Chikaishi Hospital, the Rehabilitation Hospital Affiliated with Nagoya City University School of Medicine, or other locations, and voluntarily offered to participate
(3) Individuals who are 18 years of age or older at the time consent is obtained
(4) Individuals who possess the cognitive ability necessary to complete the questionnaire
(5) Individuals from whom written consent (or electronic consent for online participants) to participate in this study has been obtained
Key exclusion criteria
(1) Individuals whom the principal investigator determines would experience excessive psychological stress from participating in the social gathering
(2) Any other individuals whom the principal investigator determines are unsuitable as research participants for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Nakao |
Organization
Nagoya City University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
467-8604
Address
Nagoya City University Rehabilitation Hospital Mikanyama 1-2 Yatomi-cho, Mizuho-ku, Nagoya-city, Aichi,
TEL
052-680-8123
nakao@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Nakao |
Organization
Nagoya City University Rehabilitation Hospital
Division name
The Department of Rehabilitation Medicine
Zip code
467-8604
Address
Nagoya City University Rehabilitation Hospital Mikanyama 1-2 Yatomi-cho, Mizuho-ku, Nagoya-city, Aic
TEL
052-680-8123
Homepage URL
nakao@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medicine
Institute
Department
Personal name
Mari Nakao
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRG Secretary General, Nagoya City University
Address
1 Kawasumi Mizuho-cho Mizuho-ku, Nagoya-city
Tel
052-853-8348
irb_jimu@med.nagoya-cu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
Reiwa7-21
Org. issuing International ID_1
Touhoku Seikatsu Bunka University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
Suspended
Date of protocol fixation
| 2025 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072334
