UMIN ID: UMIN000056621
Registered date:06/01/2025
The development and effectiveness of brief interventions for alcohol delivered by community pharmacists
Basic Information
Recruitment status | Pending |
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Health condition(s) or Problem(s) studied | 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). |
Date of first enrollment | 2025/01/20 |
Target sample size | 231 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 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. 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. 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. |
Outcome(s)
Primary Outcome | Change in weekly amount of alcohol intake from baseline to 3 months later(g) |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Wakayama Medical University |
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Secondary Sponsor | |
Source(s) of Monetary Support | Wakayama Medical University |
Secondary ID(s) | 202402 |
Contact
public contact | |
Name | Kanae YASUI |
Address | 25-1, Shichi-bancho, Wakayama City, Wakayama Prefecture Japan 640-8156 |
Telephone | 073-488-1843 |
yasui-k@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University School of Pharmaceutical Sciences, Department of Social and Community Pharmacy |
scientific contact | |
Name | Hiroshi OKADA |
Address | 25-1, Shichi-bancho, Wakayama City, Wakayama Prefecture Japan |
Telephone | 073-488-1843 |
okada_h@wakayama-med.ac.jp | |
Affiliation | Wakayama Medical University School of Pharmaceutical Sciences, Department of Social and Community Pharmacy |