UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032879 |
|---|---|
| Receipt number | R000037465 |
| Scientific Title | Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management. |
| Date of disclosure of the study information | 2018/06/17 |
| Last modified on | 2021/12/13 10:08:43 |
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Basic information
Public title
Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Acronym
Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Scientific Title
Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Scientific Title:Acronym
Effect of the ultra-brief cognitive and behavior therapy for patients with type2 diabetes on self-management.
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of ultra-brief cognitive and behavior therapy on Glucose fluctuations and self-management in Japanese out-patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose fluctuations data (FreeStyle Libre Pro)
Key secondary outcomes
Self-care behavior in daily life (Ecological momentary assessment)
Acceptance and Action Diabetes Questionnaire (AADQ)
Mindfulness Attention Awareness Scale (MAAS)
Values Clarification Questionnaire (VCQ)
Patient Health Questionnaire-9 (PHQ-9)
Body mass index (BMI)
HbA1c
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Ultra-brief cognitive and behavior therapy: 1 session (90min to 120min)
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Japanese out-patients are included if they were between 20 and 79 years-of-age and have been receiving medical care under diagnosis of type 2 diabetes mellitus according to the classifications by the Japan Diabetes Society and World Health Organization.
Key exclusion criteria
1) cannot understand Japanese well.
2) type1 diabetes and the secondary forms of diabetes.
3) affected with severe diabetes complication; diabetic retinopathy with impaired vision, impaired renal function (eGFR <30 and macroproteinuria), painful neuropathy.
4) affected with severe cardiovascular diseases and decline in ability of daily life.
5) affected with severe mental illness.
6) Cognitive dysfunction; Altzheimer type dementia, vascular dementia, and so on.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kumano |
Organization
Waseda University
Division name
Faculty of Human Science
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
+81-4-2949-8113
hikumano@waseda.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Saito |
Organization
Waseda University
Division name
Graduate School of Human Science
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
+81-4-2949-8113
Homepage URL
tekuteke@toki.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for JSPS Research Fellow
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
Tel
+81-3-5272-1639
rinri@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-298
Org. issuing International ID_1
Waseda University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2018 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2021 | 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=R000037465
