UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037217 |
|---|---|
| Receipt number | R000042173 |
| Scientific Title | Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/06/11 06:31:16 |
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Basic information
Public title
Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Acronym
Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Scientific Title
Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Scientific Title:Acronym
Systematic review and meta-analysis of acceptance&commitment therapy for type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of usefulness and safety of ACT for type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c change from baseline within 3 to 6 months and closest value after 3 months
Self-care ability
*Summary of Diabetes Self-Care Activities(SDSCA)
All adverse events
Key secondary outcomes
Acceptance ability
*Acceptance and Action Diabetes Question (AADQ)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 diabetes
Key exclusion criteria
Patients with high blood sugar that could not be diagnosed by standard diagnostic system
Gestational diabetes
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Ohtake |
Organization
Itami Seifu Hospital
Division name
Internal medecine
Zip code
664-0011
Address
5-79, Imoji, Itami Shi, Hyogo Ken
TEL
072-778-0500
dmactsr@gmail.com
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Ohtake |
Organization
Itami Seifu Hospital
Division name
Internal medecine
Zip code
664-0011
Address
5-79, Imoji, Itami Shi, Hyogo Ken
TEL
072-778-0500
Homepage URL
dmactsr@gmail.com
Sponsor or person
Institute
Itami Seifu Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society of Psychosomatic Medicine
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
Itami Seifu Hospital
Address
5-79, Imoji, Itami Shi, Hyogo Ken
Tel
072-778-0500
dmactsr@gmail.com
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
| 2019 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Search method>
Electronic search
1. The Cochrane Central Register of Controlled Trials (CENTRAL);
2. MEDLINE via Ovid;
Other resources
1. The World Health Organization International Clinical Trials Platform Search Portal (ICTRP)
2. Embase
<Meta-analysis>
Implemented using Review Manager software (RevMan 5.3). Use Random-effects model.
<Subgroup analysis>
Perform the following subgroup analysis to assess clinical research participant and intervention heterogeneity.
1. ACT session; less than 12 times, greater than or equal to 12 times
2. BMI; less than 30, greater than or equal to 30
<Sensitivity analysis>
Perform the following sensitivity analysis on primary outcomes.
1. Exclusion of studies using imposed statistics.
2. Missing participants:
Best-best scenario: all missing patients in the two groups remain unchanged
Best-worst scenario: all missing patients in the intervention group remaining unchanged and all missing patients in the control group have outcomes
Worst-best scenario: all missing patients in the intervention group have outcomes and all missing patients in the control group remain unchanged
* primary analysis (worst-worst scenario: all missing patients in the two groups have outcomes)
Management information
Registered date
| 2019 | Year | 07 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042173
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
