UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051234 |
|---|---|
| Receipt number | R000058429 |
| Scientific Title | Mental and physical responses to chat in older people with dementia |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2025/03/06 14:01:54 |
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Basic information
Public title
Mental and physical responses to chat in older people with dementia
Acronym
Mental and physical responses to chat in older people with dementia
Scientific Title
Mental and physical responses to chat in older people with dementia
Scientific Title:Acronym
Mental and physical responses to chat in older people with dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to obtain evidence of chatter in dementia care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant changes in pulse rate, blood pressure, and autonomic nervous activity before and after chat
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
chat
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants are those who have preserved hearing and speech functions that allow conversational interaction, who are not averse to chat, who can maintain a sitting position for about 20 minutes, and who have no palpable arrhythmia.
Key exclusion criteria
Those who do not retain function for conversational interaction, dislike chat, cannot maintain a sitting position for 20 minutes, or have an irregular heartbeat are excluded from participants.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Masae |
| Middle name | |
| Last name | Tsutsumi |
Organization
Yamaguchi University
Division name
Yamaguchi University Graduate School of Medicine
Zip code
755-8505
Address
1-1-1,Minami-Kogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2818
tutumi@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masae |
| Middle name | |
| Last name | Tsutsumi |
Organization
Yamaguchi University
Division name
Graduate School of Medicine
Zip code
755-8505
Address
1-1-1, Minami-Kogushi, Ube, Yamaguchi
TEL
0836-22-2818
Homepage URL
tutumi@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Administration General Affairs Office, Faculty of Medicine and Health Sciences Yamaguchi University
Address
1-1-1, Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2007
me202@yamaguchi-u.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 | 06 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since the participants were frail elderly persons requiring nursing care, permission to conduct the investigation could not be obtained from the facility due to concerns about the spread of infectious diseases. Therefore, it was decided to cancel the investigation.
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058429
