UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051615 |
|---|---|
| Receipt number | R000056257 |
| Scientific Title | Development of a Dementia Severity-Specific Enjoyment Program for Enjoying Life Throughout Your Lifetime |
| Date of disclosure of the study information | 2023/07/14 |
| Last modified on | 2023/07/14 15:35:33 |
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Basic information
Public title
Developing the Enjoyment Program to help people with dementia enjoy life throughout their lives.
Acronym
Developing the Enjoyment Program for People with Dementia
Scientific Title
Development of a Dementia Severity-Specific Enjoyment Program for Enjoying Life Throughout Your Lifetime
Scientific Title:Acronym
Development of the enjoyment Program by Dementia Severity Level
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a program for people with mild/moderate and severe dementia to enjoy the present and to examine its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini-Mental State Examination
Measurements will be taken twice, before and after (approximately 3-4 months later) the implementation of the fun program.
Key secondary outcomes
Neuropsychiatric Inventory
Model of Human Occupation Screening Tool
Functional Independence Measure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Two programs, the Mild/Moderate Dementia Fun Program and the Severe Dementia Program, will be implemented 12-15 times to examine primary and secondary outcomes.The first half of the enjoyment program is in the form of a lecture on the 18 enjoyments of leisure activities, while the second half of the enjoyment program is a reflection on the 18 enjoyments after the actual implementation of the leisure activities.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with a confirmed diagnosis of dementia
Key exclusion criteria
Subjects for whom the Elderly Version Leasure Activity Enjoyment Scale cannot be administered.
Subjects with sitting endurance of 1 hour or less
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TOSHIHIRO |
| Middle name | |
| Last name | HONKE |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757 kanazawa, tobetsu-cho, hokkaido
TEL
0133-23-1211
honke@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | TOSHIHIRO |
| Middle name | |
| Last name | HONKE |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757 kanazawa, tobetsu-cho, hokkaido
TEL
0133-23-1211
Homepage URL
honke@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido, School of Rehabilitation Sciences
Institute
Department
Personal name
TOSHIHIRO HONKE
Funding Source
Organization
Japan Society for the Promotion of Science
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
Health Sciences University of Hokkaido
Address
1757kanazawa tobetsucho hokkaido
Tel
0123331211
kyo-reha@hoku-iryo-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 | 07 | Month | 14 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056257
