UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051257 |
|---|---|
| Receipt number | R000058303 |
| Scientific Title | A survey of the status of the implementation of non-pharmacological therapies for dementia or cognitive decline among the elderly against and of the needs of those receiving and providing the therapies |
| Date of disclosure of the study information | 2023/06/05 |
| Last modified on | 2023/06/05 10:04:39 |
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Basic information
Public title
A survey of the status of the implementation of non-pharmacological therapies for dementia or cognitive decline among the elderly against and of the needs of those receiving and providing the therapies
Acronym
A survey of the status of the implementation of non-pharmacological therapies for cognitive decline among the elderly and of the needs of those receiving and providing the therapies
Scientific Title
A survey of the status of the implementation of non-pharmacological therapies for dementia or cognitive decline among the elderly against and of the needs of those receiving and providing the therapies
Scientific Title:Acronym
A survey of the status of the implementation of non-pharmacological therapies for cognitive decline among the elderly and of the needs of those receiving and providing the therapies
Region
| Japan |
Condition
Condition
1.Non-drug therapy users and their families
2.Health and care professionals
3.General healthy elderly people
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will survey older adults receiving non-pharmacological therapies to prevent dementia or cognitive decline, their caregivers, and health and care professionals who provide the therapies, to determine the status of the implementation of the therapies and the challenges of this process. In addition, we will survey healthy elderly community-dwelling persons who are not currently interested in non-pharmacological therapies but who may use the therapies in the future, to assess their knowledge of the therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Whether or not the patient is receiving non-pharmacological treatment.
2.If not, why not?
3.Type of non-pharmacological therapy received, purpose, frequency, duration per visit, place of implementation, form of implementation, reason for the visit, reason for selection, reason for practice, perceived effectiveness of non-pharmacological therapy, and level of satisfaction.
Key secondary outcomes
1.The purpose of non-pharmacological treatment, its effects, impact, and effectiveness.
2.Issues related to non-pharmacological therapies.
3.kinds of Non-pharmacological therapies they would like to try.
4.About interest in new non-pharmacological therapies.
5.Expectations for the use of digital devices for non-drug therapies.
6.Methods of publicizing and advertising effective non-drug therapies.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Self-reported "persons who are receiving or intend to receive non-pharmacological therapies to prevent cognitive decline, etc., or whose family members want them to receive pharmacological therapies in the near future" and their family members, who will participate in this survey of their own free will. Moreover, health or care professionals who self-report that they provide non-pharmacological therapies and who will participate freely and voluntarily in the study. Furthermore, according to self-reports, individuals who have no memory loss or cognitive impairment, have no difficulty with daily living, are between 60 and 79 years of age, and who will participate freely and voluntarily in the study.
Key exclusion criteria
Those who do not select "I agree" in the "I agree to this survey" box set up on the survey form for this survey.
Target sample size
3200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kazui |
Organization
Kochi University
Division name
Department of Neuropsychiatry, Kochi Medical School
Zip code
783-8505
Address
Kohasu Oko-cho, Nankoku, Kochi
TEL
0888802359
kazui@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoka |
| Middle name | |
| Last name | Tadokoro |
Organization
Kochi University
Division name
Department of Neuropsychiatry, Kochi Medical School
Zip code
783-8505
Address
Oko-cho,Nankoku city,Kochi
TEL
0888802359
Homepage URL
im28@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Hiroaki Kazui
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kochi University School of Medicine
Address
Kohasu Oko-cho, Nankoku, Kochi
Tel
088-880-2180
is21@kochi-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 | 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
1726
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
English
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058303
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