UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057210 |
|---|---|
| Receipt number | R000065334 |
| Scientific Title | Open dialogue approach to support decision-making for older adults with dementia: feasibility study |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/03/26 14:17:31 |
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Basic information
Public title
Open dialogue approach to support decision-making for older adults with dementia: feasibility study
Acronym
Open dialogue approach to support decision-making for older adults with dementia: feasibility study
Scientific Title
Open dialogue approach to support decision-making for older adults with dementia: feasibility study
Scientific Title:Acronym
Open dialogue approach to support decision-making for older adults with dementia: feasibility study
Region
| Japan |
Condition
Condition
Mild cognitive disorder, dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the feasibility of open dialogue-style dialogue practice to supporting decision-making for old elders with dementia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre- and post-intervention interviews with older adults with dementia and their families to assess the extent to which conflicts were resolved and their satisfaction with the intervention, and post-intervention interviews with staff to assess implementation difficulties and burden.
Key secondary outcomes
Families' background: age, sex, relationship to the patient (obtained from medical
records pre-intervention)
Patient information: age, sex, diagnosis, presence of inhabitant (obtained from
medical records pre-intervention)
Severity of dementia (using Clinical Dementia Scale pre-intervention)
Patient's cognitive function (using Mini-Mental State Examination pre-
intervention)
Patient's ADL (using Physical Self-Maintenance Scale pre-intervention)
Patient's neuropsychiatric symptoms (using Neuropsychiatric Inventory before
the intervention, at the end of the intervention, and 2 months after the end of
the intervention)
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
| Other |
Interventions/Control_1
Open dialogic practices
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MCI
Aged 60 years or older
Clinically diagnosed with MCI by a doctor
CDR is 0.5
Living at home
Conflicts with family members in decision-making
Able to obtain written consent from the individual to participate in the study
of their own free will
Early dementia
Aged 60 years or older
Clinically diagnosed with dementia by a doctor
CDR is 1.0
Living at home
Conflicts with family members in decision-making
Able to obtain written consent from the individual to participate in the study
of their own free will
Family
Conflicts with patient in decision-making (No relationship to the patient is required)
Able to obtain written consent from the individual to participate in the study
of their own free will
Key exclusion criteria
MCI
dementia
history of mental disorder
traumatic brain injury, or alcohol or other drug abuse
mental retardation, and severe communication disabilities such as visual or
hearing impairment
Early dementia
history of mental disorder
traumatic brain injury, or alcohol or other drug abuse
mental retardation, and severe communication disabilities such as visual or
hearing impairment
Family
history of mental disorder
traumatic brain injury, or alcohol or other drug abuse
mental retardation, and severe communication disabilities such as visual or
hearing impairment
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Kato |
Organization
Graduate school of medical science, Kyoto prefectural university of medicine
Division name
Department of psychiatry
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
0752515612
y-kato@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kato |
Organization
Graduate school of medical science, Kyoto prefectural university of medicine
Division name
Department of psychiatry
Zip code
6028566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
0752515612
Homepage URL
y-kato@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate school of medical science, Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of psychiatry, graduate school of medical science, Kyoto prefectural university of medicine
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
Department of Psychiatry, graduate school of medical science, Kyoto prefectural university of medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Tel
0752515612
psyche@koto.kpu-m.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
| 2025 | Year | 03 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | 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
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065334
