UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042616 |
|---|---|
| Receipt number | R000048605 |
| Scientific Title | A community-based survey of feeding and dysphagia in Parkinson's disease patients |
| Date of disclosure of the study information | 2020/12/04 |
| Last modified on | 2023/12/04 21:26:29 |
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Basic information
Public title
A community-based survey of feeding and dysphagia in Parkinson's disease patients
Acronym
A community-based survey of feeding and dysphagia in Parkinson's disease patients
Scientific Title
A community-based survey of feeding and dysphagia in Parkinson's disease patients
Scientific Title:Acronym
A community-based survey of feeding and dysphagia in Parkinson's disease patients
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dysphagia in Parkinson's disease (PD) occurs in 50-90% of patients with dysphagia, and aspiration pneumonia is the leading cause of death in PD patients.
However, PD patients often have no mucus when they aspirate and are often unaware of their feeding and swallowing difficulties.
Therefore, the diagnosis of dysphagia is often made after the onset of aspiration pneumonia.
It's not. early detection is necessary to prevent pneumonia, but the social environment is often not conducive to testing swallowing function.
Basic objectives2
Others
Basic objectives -Others
A survey of PD patients in questionnaires and questionnaires should be administered to patients with PD in the community exercise class "PD cafe" was held at a rented location for local PD patients swallowing.
The purpose of this study was to understand the function and support system for feeding and dysphagia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Japanese version of the 10 item Eating Scale Tool
2) Questionnaire
Key secondary outcomes
3) Japanese translation of the Dysphagia Handicap Index
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
EAT-10
questionnaire
DHI-J
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who came to "PD cafe" on or after April 1, 2019, and consented to this study's explanatory document
Key exclusion criteria
Those with writing difficulties or cognitive decline who are unable to answer the questionnaire
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nakayama |
| Middle name | |
| Last name | Keigo |
Organization
National Centre of Neurology and Psychiatry
Division name
Department of Rehabilitaion
Zip code
1878551
Address
Kodaira, Tokyo, Ogawahigashi city 4-1-1
TEL
08011603366
stnakayama@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Nakayama |
| Middle name | |
| Last name | Keigo |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Rehabilitation
Zip code
1878551
Address
Kodaira, Tokyo, Ogawahigashi city 4-1-1
TEL
0423412711
Homepage URL
stnakayama@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
None
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
National Center of Neurology and Psychiatry
Address
Kodaira, Tokyo, Ogawahigashi city 4-1-1
Tel
08011603366
stnakayama@ncnp.go.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
| 2020 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
COVID-19 has made it difficult to conduct face-to-face questionnaires by other institutions, so the study is terminated.
Management information
Registered date
| 2020 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
