UMIN-CTR Clinical Trial

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
Email	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
Email	kanamaru-kouji@ed.tmu.ac.jp

Sponsor
Institute	Tokyo Metropolitan University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049591