UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046377 |
|---|---|
| Receipt number | R000052923 |
| Scientific Title | Relationship between Olfactory Decline and BPSD, Life Function, and Dementia Severity in Dementia Patients Using Card Olfactory Identification Test |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2021/12/15 03:59:07 |
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Basic information
Public title
Relationship between Olfactory Decline and BPSD, Life Function, and Dementia Severity in Dementia Patients Using Card Olfactory Identification Test
Acronym
Relationship between Olfactory Decline and BPSD, Life Function, and Dementia Severity in Dementia Patients Using Card Olfactory Identification Test
Scientific Title
Relationship between Olfactory Decline and BPSD, Life Function, and Dementia Severity in Dementia Patients Using Card Olfactory Identification Test
Scientific Title:Acronym
Relationship between Olfactory Decline and BPSD, Life Function, and Dementia Severity in Dementia Patients Using Card Olfactory Identification Test
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to objectively evaluate olfactory function in patients with dementia admitted to psychiatric hospitals using card-based olfactory identification test (Open Essence; OE), and to assess (1) whether olfactory function is related to BPSD, (2) whether olfactory function is related to life function, and (3) whether olfactory function is related to dementia severity, to clarify the characteristics of each of these.
Basic objectives2
Others
Basic objectives -Others
Items aimed at assessing relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Olfaction test:
1) Card-type olfactory identification test
2) Daily smell questionnaire
2. Personal attributes3. Physical function assessment
1) Grip strength
2) Loco check
3) 10-meter walk
4. Mental function assessment
1) Dementia Severity(Clinical Dementia Rating; CDR)
2) Cognitive function assessment(Mini-Mental State Examination; MMSE)
3) Assessment of behavioral and psychological symptoms of dementia (Dementia Behavior Disturbance Scale; DBD)
5.Activities of daily living assessment
1) Functional Independence Measure(FIM)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who have explained the purpose, methods, and ethical considerations of this study to the patient and his/her family, and have obtained consent.
2. Those whose general condition is stable.
3. Those who are able to communicate stably.
Key exclusion criteria
1. Patients with severe dementia who show "severe dementia" in the dementia severity assessment.
2. Patients with psychiatric disorders other than dementia.
3. Patients who cannot continue the evaluation.
4. Those whose sense of smell is affected by medication.
5. Patients with a history of sinusitis or other conditions that cause olfactory loss.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Mikata |
Organization
Kibi University of International Studies (Communication System
Division name
Graduate School of Health Sciences studies Department of Occupational Therapy, master's Course
Zip code
716-8508
Address
8 Iga-machi, Takahashi City, Okayama Prefecture
TEL
0886-22-9454
lookingfor5happys@gmail.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Mikata |
Organization
National Health Insurance Nogami Kosei General Hospital
Division name
Psychiatric Occupational Therapy Room
Zip code
640-1141
Address
Syoubata, Kiminotyou, Kaisou-gun, Wakayama
TEL
073-489-2178
Homepage URL
lookingfor5happys@gmail.com
Sponsor or person
Institute
Kibi University of International Studies (Communication System)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kibi University of International Studies (Communication System)
Address
8 Iga-machi, Takahashi City, Okayama Prefecture
Tel
0886-22-9454
lookingfor5happys@gmail.com
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
| 2021 | Year | 12 | Month | 15 | 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
| 2021 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design
cross-sectional survey research
Method of recruiting eligible patients
Patients who were admitted to a psychiatric hospital between January 2022 and June 2022, diagnosed with dementia, and meet the inclusion and exclusion criteria.
Items to be evaluated
1. Olfactory items
1)Olfactory identification test, 2)Daily smell questionnaire
2. Personal attributes
1)Age, 2)Gender, 3)Name of dementia disease, 4)Medical history, 5)Medication history, 6)Olfactory function history
3. Physical function
1)Grip strength, 2)locomotion questionnaire, 3)10-meter walk
4. Mental function
1)Dementia, 2)Cognitive function, 3)BPSD assessment
5. ADL assessment
Management information
Registered date
| 2021 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052923
