UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045909 |
|---|---|
| Receipt number | R000052409 |
| Scientific Title | Exploratory study of the effects of intervention by distributing educational materials for children with type 1 diabetes |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2023/05/03 09:21:20 |
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Basic information
Public title
Exploratory study of the effects of intervention by distributing educational materials for children with type 1 diabetes
Acronym
Exploratory study of the effects of intervention by distributing educational materials for children with type 1 diabetes
Scientific Title
Exploratory study of the effects of intervention by distributing educational materials for children with type 1 diabetes
Scientific Title:Acronym
Exploratory study of the effects of intervention by distributing educational materials for children with type 1 diabetes
Region
| Japan |
Condition
Condition
children with type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of intervention effect by distributing specialized cartoons to children with type 1 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Knowledge of diabetes after 6 months
Key secondary outcomes
Exercise habits after 6 months
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Distribution of educational materials
Intervention period is 6 months
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
| 8 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those with type 1 diabetes
Children from 8 to 15 years old
Those who can obtain the consent of the person and their parents
Key exclusion criteria
Those with serious illnesses or injuries other than type 1 diabetes
Those who are restricted from exercising by a doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
Tsukuba University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3050044
Address
2-1-1 Amakubo
TEL
+819062872557
minaminagasaki2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3050044
Address
2-1-1 Amakubo
TEL
09062872557
Homepage URL
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo
Tel
+819062872557
minaminagasaki2007@yahoo.co.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 | 11 | Month | 05 | 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
| 2021 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052409
