UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025260 |
|---|---|
| Receipt number | R000029055 |
| Scientific Title | Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2016/12/13 19:20:21 |
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Basic information
Public title
Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Acronym
Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Scientific Title
Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Scientific Title:Acronym
Consideration of "Animal test" as screening for dementia and related dementia test in diabetic patients
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sought to examine the relationship between the the one-minute animal test (OMAT) and the Hasegawa's Dementia Scale-Revised (HDS-R)scores, and determine the cut-off OMAT score that balanced the sensitivity and specificity in identifying HDS-R-positive patients among all patients as well as in the subgroup of patients aged 65 years or older.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the cut-off score of OMAT that balanced the sensitivity closest to 1.00 and enabled the highest specificity for the HDS-R-positive status
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Execute OMAT and HDS-R once each at the time of consultation.
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients with diabetes who visited the outpatient clinic at Fujiidera Municipal Hospital from January 2014 to June 2015.
Key exclusion criteria
Patients who the informed consent was not obtained.
Target sample size
122
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Kinuhata |
Organization
Osaka City University, Graduate School and Faculty of Medicine
Division name
Department of General Practice & Medical Education
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
+81-6-6645-3797
3doutor3@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Kinuhata |
Organization
Osaka City University, Graduate School and Faculty of Medicine
Division name
Department of General Practice & Medical Education
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
+81-6-6645-3797
Homepage URL
3doutor3@gmail.com
Sponsor or person
Institute
Osaka City University, Graduate School and Faculty of Medicine
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
Address
Tel
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
| 2016 | Year | 12 | Month | 13 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2016 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029055
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| Registered date | File name |
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