UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050581 |
|---|---|
| Receipt number | R000057611 |
| Scientific Title | Feasibility trial for community-adapted dementia prevention program through multi-domain intervention for community-dwelling older adults at risk for dementia |
| Date of disclosure of the study information | 2023/04/18 |
| Last modified on | 2023/03/14 14:35:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility trial for community-adapted dementia prevention program through multi-domain intervention for community-dwelling older adults at risk for dementia
Acronym
Multi-domain intervention program for community-dwelling elderly
Scientific Title
Feasibility trial for community-adapted dementia prevention program through multi-domain intervention for community-dwelling older adults at risk for dementia
Scientific Title:Acronym
Multi-domain intervention program for community-dwelling elderly
Region
| Japan |
Condition
Condition
Older adults with mild cognitive impairment
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
his study aims to assess the feasibility of an adapted multi-domain intervention program for dementia prevention in a local community setting.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is the proportion of participants who continue to participate in the adapted multi-domain intervention program
Key secondary outcomes
Program Providers
1. compliance with protocol implementation
2. Acceptability of the intervention
3. Cost of intervention
4. appropriateness of intervention
5. intervention fidelity
Program participants
1. acceptability of the intervention
2. disincentives and facilitators for continued participation (questionnaires, interviews) 3.
3. changes in MoCA-J scores from the initial evaluation to the 6-month post-evaluation 4. changes in behavior from the initial evaluation to the 6-month post-evaluation
4. changes in behavior change indices from the initial evaluation to the 6-month follow-up evaluation 5.
5. change in food intake diversity score from the time of the initial evaluation to 6 months
6. change in social participation from the initial assessment to 6 months
7. change in lifestyle from the initial assessment to 6 months 8.
8. change in physical activity from the time of initial assessment to 6 months
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will receive a multi-domain intervention program with lifestyle management, exercise instruction, nutritional guidance, cognitive training, and social participation.
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
| 86 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) aged 65-85 at the time of enrollment
2) have provided a written informed consent on this study by participants.
Key exclusion criteria
Subjects who
1) are needed to restrict any physical exercise and/or diet due to functional decline, including presence of bone or joint disease, renal failure, ischemic heart disease, and cardiopulmonary disorders."
2) are diagnosed with dementia.
3) have a MMSE score of less than 21.
4) are unable to speak in Japanese.
5) are unable to perform cognitive tests.
6) have a care-needs certification in the long-term care insurance system.
7) have a history of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; current serious or unstable disease.
8) are deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakurai |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Prevention and Care Science
Zip code
474-8511
Address
7-430 Morioka, Obu, Aichi, JAPAN
TEL
0562-46-2311
tsakurai@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Kuroda |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Prevention and Care Science
Zip code
474-8511
Address
7-430 Morioka, Obu, Aichi, JAPAN
TEL
0562-46-2311
Homepage URL
kuroda@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Obu city
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430 Morioka, Obu, Aichi 474-8511, JAPAN
Tel
0562-46-2311
kuroda@ncgg.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
| 2023 | Year | 04 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057611
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
