UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052946 |
|---|---|
| Receipt number | R000060411 |
| Scientific Title | Effects of meaningful activity on stress in older patients with dementia: a crossover comparative study using the Activity Quality Assessment (A-QOA) |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2023/11/29 14:44:58 |
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Basic information
Public title
Effects of meaningful activity on stress in older patients with dementia: a crossover comparative study using the Activity Quality Assessment (A-QOA)
Acronym
Effects of meaningful activity on stress in older patients with dementia: a crossover comparative study using the Activity Quality Assessment (A-QOA)
Scientific Title
Effects of meaningful activity on stress in older patients with dementia: a crossover comparative study using the Activity Quality Assessment (A-QOA)
Scientific Title:Acronym
Effects of meaningful activity on stress in older patients with dementia: a crossover comparative study using the Activity Quality Assessment (A-QOA)
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of meaningful activities selected by the Assessment of Quality of Activities (A-QOA) and other activities on stress in older patients with dementia, as assessed by salivary amylase.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Evaluation period:
Immediate pre-and-post intervention
Outcome: Stress value by salivary amylase
Key secondary outcomes
Evaluation period:
Before intervention
1:Clinical Dementia Rating (CDR)
2:Assessment of Quality of Activities(A-QOA)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A:30 minutes of meaningful activity selected by A-QOA, once a week, 4 times a month - Wash out period (1 week) - B:30 minutes of regular activity such as watching TV, once a week, 4 times a month.
Interventions/Control_2
B:30 minutes of regular activity such as watching TV, once a week, 4 times a month - Wash out period (1 week) - A:30 minutes of meaningful activity selected by A-QOA, once a week, 4 times a month.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with moderate to severe dementia with a Clinical Dementia Rating(CDR) of 2 or higher.
Ability to spend at least 30 minutes in a wheelchair.
Able to express participation in activities.
Key exclusion criteria
Severely depressed patients.
Patients with severe heart disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Ogawa |
Organization
Kobe Gakuin University.
Division name
Graduate school of comprehensive rehabilitation.
Zip code
651-2180
Address
518 Arise, Ikawadani, Nishi-ku, Kobe-shi, Hyogo
TEL
078-974-2043
mogawa@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yamaguchi |
Organization
Tsurumaki Onsen Hospital
Division name
Rehabilitation Department
Zip code
257-0001
Address
1-16-1 Tsurumakikita, Hadano City, Kanagawa Prefecture
TEL
0463-78-1326
Homepage URL
yamaguchi-t@tsurumaki-hp.jp
Sponsor or person
Institute
Tsurumaki Onsen Hospital,Rehabilitation Department,Takuya Yamaguchi
Institute
Department
Personal name
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
Tsurumaki Onsen Hospital
Address
1-16-1 Tsurumakikita, Hadano City, Kanagawa Prefecture
Tel
0463-78-1311
riha@sankikai.or.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 | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060411
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
