UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056621 |
|---|---|
| Receipt number | R000064701 |
| Scientific Title | The development and effectiveness of brief interventions for alcohol delivered by community pharmacists: cluster randomized controlled trial |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2026/01/05 17:25:11 |
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Basic information
Public title
The development and effectiveness of brief interventions for alcohol delivered by community pharmacists
Acronym
COMPASS-REDUCE: COMmunity Pharmacists ASSist for patients - Reducing Alcohol Use
Scientific Title
The development and effectiveness of brief interventions for alcohol delivered by community pharmacists: cluster randomized controlled trial
Scientific Title:Acronym
COMPASS-REDUCE: COMmunity Pharmacists ASSist for patients - Reducing Alcohol Use, Cluster Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Patients who have been prescribed antihypertensive drugs or oral diabetes drugs, regularly receive medication at the research-participating pharmacy (for more than 3 months), and are scored 8-14 on the AUDIT (Alcohol Use Disorders Identification Test).
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop a brief interventions for alcohol that can be implemented in pharmacies, and verify its effectiveness and feasibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in weekly amount of alcohol intake from baseline to 3 months later(g)
Key secondary outcomes
AUDIT, AUDIT-C, Body weight(kg), BMI, Blood pressure(mmHg), HbA1c, Blood glucose level, WBC, RBC, Hemoglobin, Hematocrit, MCV, AST, ALT, Gamma-GTP
Change in weekly amount of alcohol intake from baseline to 6 months later(g)
Prescription medication information
Knowledge, motivation, and attitudes about the impact of alcohol on health in research participants
Knowledge, confidence, and attitudes about drinking reduction support in research participating pharmacists
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Group A: In addition to the regular medication guidance, provision of 90 bottles of 350mL non-alcoholic beverages (30 bottles, 3 times) and brief interventions for drinking by a pharmacist for 3 months.
Interventions/Control_2
Intervention Group B: In addition to the regular medication guidance, provision of 18 bottles of 350mL non-alcoholic beverages (6 bottles, 3 times) and brief interventions for drinking by a pharmacist for 3 months, with an additional 6 bottles provided to those who wish after 3 months.
Interventions/Control_3
Control Group: Regular medication guidance only. After the end of the 3-month waiting period, 24 bottles of 350mL non-alcoholic beverages and materials for drinking reduction support are provided to those who need.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 20 years or older
2) People scored between 8-14 on the AUDIT (Alcohol Use Disorders Identification Test)
Key exclusion criteria
1) People who are receiving treatment for alcohol problems
2)People who are participating in other alcohol-related studies
3)Dialysis patients
4)Pregnant or breastfeeding individuals
5)People who are taking psychiatric medications such as antidepressants, anti-anxiety drugs, antipsychotics (excluding sleep-inducing drugs)
6)People who cannot visit the pharmacy continuously for the research period of 3 months
7)People who do not agree to be contacted by the pharmacist by phone, email, etc. during the research period
8)Others who the principal investigator has judged to be unsuitable for research participation
Target sample size
231
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | ITO |
Organization
Wakayama Medical University
Division name
School of Pharmaceutical Sciences, Department of Medical Informatics
Zip code
640-8156
Address
25-1, Shichi-bancho, Wakayama City, Wakayama Prefecture
TEL
073-488-3385
taito@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | KOTANI |
Organization
Wakayama Medical University
Division name
School of Pharmaceutical Sciences, Department of Social and Community Pharmacy
Zip code
640-8156
Address
25-1, Shichi-bancho, Wakayama City, Wakayama Prefecture
TEL
090-2444-9442
Homepage URL
kotaccimko@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University, Graduate School of Medicine, School of Public Health, Department of Preventive Services, Dr.Hiroshi OKADA
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Association for Community Pharmacy
Address
1-6-23, Meguro-ward, Meguro, Tokyo-city
Tel
03-6303-9181
ksuezawa@nifty.com
Secondary IDs
Secondary IDs
YES
Study ID_1
202402, 202503, 202509, 202510
Org. issuing International ID_1
Japanese Association for Community Pharmacy
Study ID_2
T4386
Org. issuing International ID_2
Wakayama Medical University
IND to MHLW
Institutions
Institutions
エバグリーン薬局 新中島店（和歌山県）、エバグリーン薬局 塩屋店（和歌山県）、エバグリーン薬局 紀三井寺店（和歌山県）、エバグリーン薬局 宮街道店（和歌山県）、エバグリーン薬局 古屋店（和歌山県）、エバグリーン薬局 和泉芦部店（大阪府）、エバグリーン薬局 四ヶ郷店（和歌山県）、エバグリーン薬局 高松店（和歌山県）、エバグリーン薬局 福島店（和歌山県）、オール薬局 白島店（広島県）、オール薬局 八丁堀店（広島県）、オール薬局 五日市西店（広島県）、オール薬局 五日市店（広島県）、オール薬局 山本店（広島県）、オール薬局 府中店（広島県）、オール薬局 乃木店（島根県）、オール薬局 深川店（広島県）、オール薬局 新栄橋店（広島県）、薬局トモズ 宮前平店（神奈川県）、薬局トモズ ちはら台店（千葉県）、薬局トモズ ビーンズ新杉田店（神奈川県）、薬局トモズ キテミテマツド店（千葉県）、薬局トモズ 中山店（神奈川県）、薬局トモズ 向島店（東京都）、薬局トモズ 池尻大橋店（東京都）、薬局トモズ 京成曳舟店（東京都）、薬局トモズ 武蔵新城店（神奈川県）、池田薬局 マカベ調剤店（秋田県）、パル薬局 上福岡店（埼玉県）、スター調剤薬局 皇徳寺店（鹿児島県）、スター調剤薬局 星ヶ峯店（鹿児島県）、スター調剤薬局 うすき店（鹿児島県）、スター調剤薬局 上福元店（鹿児島県）、白男川薬局本店（鹿児島県）、五大薬局 青山店（兵庫県）、ばんどう薬局（大阪府）、かんひちや薬局 甲賀店（三重県）、きらきら薬局（熊本県）、クスノキ薬局 むけ店（鹿児島県）、町のそうだん薬局（奈良県）、天使の空薬局 下里店（和歌山県）、なごみ薬局（和歌山県）、すみれ調剤薬局（和歌山県）、さんご薬局（和歌山県）、なぎさ薬局（和歌山県）、はまゆう調剤薬局（和歌山県）、エグチ薬局（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | 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
93
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
(1)Procedure for registering participating pharmacies
Recruitment for participation will be conducted and registration will be completed at Evergreen Pharmacy (Wakayama Prefecture) and MyLife Owl Pharmacy Co., Ltd. (Hiroshima Prefecture and others). In addition, we will request cooperation from pharmacies introduced by MyLife Owl Pharmacy Co., Ltd. and member pharmacies of the Wakayama Pharmaceutical Association, and register those that apply (see the list of study sites). Pharmacists participating in the study will attend lectures and training necessary for brief intervention (BI) for drinking reduction support at a training session after registration.
(2)Procedure for participant registration
Ensure that the target patient meets all the selection criteria and does not meet any of the exclusion criteria, and obtain written informed consent. Enter the necessary information into the format on the web after anonymizing personal information and register. The registration office will determine eligibility and complete case registration. The pharmacist in charge will start the brief intervention (BI) for drinking reduction support after registration is completed.
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064701
