UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051388 |
|---|---|
| Receipt number | R000058546 |
| Scientific Title | Educational Intervention following Lifestyle Screening for Outpatients at Primary Care Clinics: A Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/10/06 11:53:08 |
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Basic information
Public title
Educational Intervention following Lifestyle Screening for Outpatients at Primary Care Clinics: A Cluster Randomized Controlled Trial
Acronym
Educational Intervention following Lifestyle Screening for Outpatients at Primary Care Clinics: A Cluster Randomized Controlled Trial
Scientific Title
Educational Intervention following Lifestyle Screening for Outpatients at Primary Care Clinics: A Cluster Randomized Controlled Trial
Scientific Title:Acronym
Educational Intervention following Lifestyle Screening for Outpatients at Primary Care Clinics: A Cluster Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Outpatients who visited primary care clinics
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Over 20% of patients in primary care clinics are reported to consume an amount of alcohol that increases the risk of lifestyle-related diseases. However, brief interventions to reduce alcohol-related issues have not been widely implemented in clinical practice.
This study aims to verify the effectiveness of reducing alcohol consumption by implementing an ultra-brief intervention (Ultra-BI) following the screening that can be conducted in 30 seconds.
Basic objectives2
Others
Basic objectives -Others
If the effectiveness of reducing alcohol consumption by conducting screening for alcohol-related issues and implementing Ultra-BI is supported, it could provide evidence for implementing Ultra-BI in primary care clinics.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Average alcohol consumption at 24 weeks
Key secondary outcomes
Average alcohol consumption at 12 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The AUDIT (Alcohol Use Disorders Identification Test) and the ultra-brief intervention (Ultra-BI) that can be performed in 30 seconds
Interventions/Control_2
AUDIT-C without Ultra-BI
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Outpatients at primary care clinics
2. 20 years or older and younger than 75 years old
3. Able to understand the informed consent document and provide written consent to participate in the study of his/her own free will.
Key exclusion criteria
1. Pregnant patients
2. Patients with suspected acute infectious diseases
3. Other patients deemed inappropriate as research subjects by investigators
Target sample size
1125
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Nouso |
Organization
Okayama City General Medical Center Okayama City Hospital
Division name
Gastroenterology
Zip code
700-8557
Address
3-20-1, Kitanagase Omote-cho, Kita-ku, Okayama City, Okayama Prefecture
TEL
086-737-3000
kazunouso@gmail.com
Public contact
Name of contact person
| 1st name | Ryuhei |
| Middle name | |
| Last name | So |
Organization
CureApp,inc.
Division name
Medical Promotion Division
Zip code
103-0001
Address
4F, 12-5, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan 103-0001
TEL
03-6231-0183
Homepage URL
ryuhei.so@cureapp.jp
Sponsor or person
Institute
CureApp,inc
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics Review Committee, National Hospital Organization Kurihama Medical Center
Address
5-3-1 Nohi, Yokosuka City, Kanagawa Prefecture
Tel
046-848-1550
220-kanri1@mail.hosp.go.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
| 2023 | Year | 06 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058546
| 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 |
