UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043431 |
|---|---|
| Receipt number | R000049591 |
| Scientific Title | Examination of the change in the anteroposterior competitive examination by the occupational therapeutic intervention to one diabetic group |
| Date of disclosure of the study information | 2021/02/26 |
| Last modified on | 2022/08/27 13:27:27 |
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Basic information
Public title
Examination of the change by the occupational therapeutic intervention in the group on diabetic
Acronym
Change of the group occupational therapeutic intervention on diabetic
Scientific Title
Examination of the change in the anteroposterior competitive examination by the occupational therapeutic intervention to one diabetic group
Scientific Title:Acronym
Anteroposterior comparison change by the occupational therapeutic intervention to one diabetic group
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I examine the change of the group occupational therapeutic intervention on patients with type 2 diabetes using an authority of care prevention place care service
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Problem Area In Diabetes Survey
Key secondary outcomes
Canadian Occupational Performance Measure, Self-Care Agency Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Programs focusing on occupational performance, self-management, metal stress with type 2 diabetes (composed by group works and lectures)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who age 65 years or older with type 2 diabetes during use of authority of care prevention place care service
Key exclusion criteria
1. The person who cannot understand the contents of this study.
2. The person who cannot show a will of the study cooperation by oneself.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | kouji |
| Middle name | |
| Last name | kanamaru |
Organization
Tokyo Metropolitan University
Division name
Master Course, Department of Occupational Therapy, Graduate School of Human Health Science
Zip code
116-0012
Address
7-2-10, Higashiogu, Arakawa-ward, Tokyo, Japan
TEL
03-3819-1211
kanamaru-kouji@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | kouji |
| Middle name | |
| Last name | kanamaru |
Organization
Tokyo Metropolitan University
Division name
Master Course, Department of Occupational Therapy, Graduate School of Human Health Science
Zip code
116-0012
Address
7-2-10, Higashiogu, Arakawa-ward, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
kanamaru-kouji@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
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
Tokyo Metropolitan University
Address
7-2-10, Higashiogu, Arakawa-ward, Tokyo, Japan
Tel
03-3819-1211
kanamaru-kouji@ed.tmu.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
| 2021 | Year | 02 | Month | 26 | 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
9
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
| 2020 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049591
