UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014265 |
|---|---|
| Receipt number | R000016618 |
| Scientific Title | Effect of the acceptance and commitment therapy for patients with type2 diabetes on glucose control and self-management: a Randomized Controlled Trial. |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2019/12/28 12:13:34 |
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Basic information
Public title
Effect of the acceptance and commitment therapy for patients with type2 diabetes on glucose control and self-management: a Randomized Controlled Trial.
Acronym
Effect of the acceptance and commitment therapy for patients with type2 diabetes : a Randomized Controlled Trial.
Scientific Title
Effect of the acceptance and commitment therapy for patients with type2 diabetes on glucose control and self-management: a Randomized Controlled Trial.
Scientific Title:Acronym
Effect of the acceptance and commitment therapy for patients with type2 diabetes : a Randomized Controlled Trial.
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 acceptance and commitment therapy on HbA1c 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
HbA1c,
The Summary of Diabetes Self-Care Activities Measure: J-SDSCA
Key secondary outcomes
body weight, body mass index (BMI), blood pressure, blood lipids,
Acceptance and Action Diabetes Questionnaire(AADQ), Problem Areas In Diabetes Survey(PAID), Attentional function scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: Acceptance and commitment therapy (3 hours) and education (1 hour)
Interventions/Control_2
Control: Education alone (4 hours)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Japanese out-patients are included if they were between 20 and 69 years-of-age and have been receiving medical care for more 6 months 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
140
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Noda |
Organization
International University of Health and Welfare
Division name
Department of Diabetes, Metabolism and Endocrinology
Zip code
272-0827
Address
6-1-14 Kohnodai, Ichikawa City, Chiba 272-0827, Japan
TEL
+81-47-375-1111
noda-3im@io.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Mineyama |
Organization
Tama Hokubu Medical Center
Division name
Department of Endocrinology and Metabolisum
Zip code
189-8511
Address
1-7-1 Aoba-Cho, Higashi-Murayama City, Tokyo, 189-8511
TEL
+81-42-396-3811
Homepage URL
tmineyama-tky@umin.ac.jp
Sponsor or person
Institute
Kohnodai Hospital, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Human Science, Waseda University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical Science, National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo 162-8655, Japan
Tel
+81-3-3202-7181(2711)
rinrijm@hosp.ncgm.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2014-020
Org. issuing International ID_1
Waseda University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立国際医療研究センター 国府台病院（千葉県）
（Kohnodai Hospital, National Center for Global Health and Medicine, Chiba, Japan）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000016618&flwp_key=1011edApl4v9
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
55
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because data analyses are in progress.
Date of the first journal publication of results
Baseline Characteristics
Japanese out-patients who were between 20 and 69 years-of-age and have been receiving medical care for more 6 months under diagnosis of type 2 diabetes mellitus according to the classifications by the Japan Diabetes Society and World Health Organization.
Participant flow
Japanese tpye2 diabetes out-patients are consecutively included at the diabetic clinic in Kohnodai Hospital, National Center for Global Health and Medicine.
Adverse events
There were no adverse events.
Outcome measures
HbA1c, The Summary of Diabetes Self-Care Activities Measure: J-SDSCA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 15 | Day |
Last modified on
| 2019 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016618
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/12/28 | H26特定課研A申請書20131101大内.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/12/28 | 症例データ仕様書.txt |
| Research case data | |
|---|---|
| Registered date | File name |
