- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03823599
Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce Alcohol Misuse in an Emergency Department
A Pilot Study on the Feasibility of Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce Alcohol Misuse in an Emergency Department in Hong Kong
This project focuses on patients in AED. Objectives of this project are:
- To examine the factors associated with alcohol drinking and alcohol use disorder
- To examine the effect of face-to-face alcohol brief intervention on drinking reduction
- To examine the effect of a continuous interactive chat-based intervention via "WhatsApp" on drinking reduction
- To explore the perception of face-to-face alcohol brief intervention
- To explore the perception of continuous interactive chat-based intervention via instant messaging mobile application "WhatsApp"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
According to the Department of Health, a local epidemiological study was conducted in 2001 and showed that about one in ten of all motor vehicle deaths were associated with alcohol consumption. Also, the statistics from the Transportation department showed that 874 vehicle accidents resulting in personal injury were related to alcohol misuse, which included 24 fatal cases between the period of 2000 and 2010. With the aforementioned statistics supported, the hospital Accident and Emergency Department (AED) serves as the most important entrance and safeguard to the healthcare system for the public, since victims of traffic accidents or violence related to heavy drinking are frequently encountered in AED, this serves as an ideal place for provision of initial alcohol intervention and further stabilization related to alcohol problem of patients. Although AED is a hectic environment with very high patients turnover, substantial evidence had shown feasibility and efficacy of Alcohol Brief Intervention (ABI) in reducing patients' subsequent alcohol drinking. In oversea, multiple research had been done to show ABI were effective and feasible for reducing alcohol misuse, but the effect was not long lasting and lead to subsequent relapse. In addition to this, no further trial has been done to investigate the feasibility of implementing an RCT on evaluating the effect of ABI and continuous chat-based intervention on reducing alcohol consumption among patients in AED in Hong Kong.
According to the WHO, the standard ABI approach includes: giving feedback and information about the screening result and hazard of drinking; emphasizing the benefits of quit drinking and informing about alcohol problems; setting goal on reducing alcohol consumption; reviewing advice and ; giving encouragement. In this pilot study, a brief alcohol counselling using face-to-face ABI will be delivered together with continuous interactive chat-based intervention via instant messaging mobile application "WhatsApp" to those patients with AUDIT score ≥ 8, who are considered to have hazardous and harmful drinking problems according to the guideline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong, 000000
- School of Nursing, The University of Hong Kong
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hong Kong resident aged 18 to 65
- scored ≥ 8 in the Alcohol Use Disorder Identification Test (AUDIT) in the past 12 months
- able to communicate in Cantonese (including reading Chinese)
- using a phone with instant messaging mobile application "WhatsApp" installed for communication.
Exclusion Criteria:
- patients with communication barrier (either physically or cognitively)
- currently participating in other alcohol treatment services or clinics
- will be hospitalized immediate after A&E consultation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Alcohol brief intervention+mobile chat-based instant messages
|
Subjects in the active arm study will receive 5-minute face-to-face ABI, alcohol leaflet from Department of Health (DH) plus continuous interactive chat-based intervention for 1 month as an extension of alcohol brief intervention at baseline
The Control group will receive face-to-face ABI plus an alcohol leaflet from DH.
|
Active Comparator: control group
Alcohol brief intervention
|
The Control group will receive face-to-face ABI plus an alcohol leaflet from DH.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in unit of alcohol consumption in gram
Time Frame: at 3-month after baseline.
|
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 3-month after baseline.
|
at 3-month after baseline.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in unit of alcohol consumption in gram
Time Frame: at 1-month after phase I
|
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 1-month after phase I
|
at 1-month after phase I
|
change in episode of binge drinking measured by asking "Never", "less than a month", "two to four times a month", " two to three times a week" and "almost everyday"
Time Frame: at 1 and 3 months after phase I
|
Defined by 5 [male] or 4 [female] in a row for binge drinking and compare the episode of binge drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires
|
at 1 and 3 months after phase I
|
change in frequency of drinking by asking "Never", "less than a month", "two to four times a month", " two to three times a week" and "almost everyday"
Time Frame: at 1 and 3 months after phase I
|
Compare the frequency of drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires
|
at 1 and 3 months after phase I
|
attempt to reduce drinking measured by asking whether they have tried to reduce drinking at past month (yes or no)
Time Frame: at 1 and 3 months after phase I
|
Compare the attempt to reduce drinking between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires
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at 1 and 3 months after phase I
|
change in confidence to reduce drinking measured by Likert scale (1-10)
Time Frame: at 1 and 3 months after phase I
|
Score ranges from 0 to 10 with higher score indicates a high level.
The score will be compared between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires
|
at 1 and 3 months after phase I
|
Alcohol Problems Scale at 1 and 3-month follow-up
Time Frame: at 1 and 3 months after phase I
|
The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires
|
at 1 and 3 months after phase I
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pilot alcohol study (AED)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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