Alcohol Use DisorderNCT03823599
Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce Alcohol Misuse in an Emergency Department
A study testing Mobile chat-based instant messages and Alcohol brief intervention in people with Alcohol Use Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This project focuses on patients in AED. Objectives of this project are: 1. To examine the factors associated with alcohol drinking and alcohol use disorder 2. To examine the effect of face-to-face alcohol brief intervention on drinking reduction 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Mobile chat-based instant messages and Alcohol brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2019to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The University of Hong Kong
Hong Kong, 000000
About this study
Official title: 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"
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Mobile chat-based instant messages, Alcohol brief intervention
- Keywords
- chat-based intervention, alcohol brief intervention, Alcohol misuse, Accident & Emergency Department, AUDIT, instant messaging
- Medical subject headings
- Alcoholism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile chat-based instant messagesBehavioural
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
Alcohol brief interventionBehavioural
The Control group will receive face-to-face ABI plus an alcohol leaflet from DH.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Alcohol brief intervention+mobile chat-based instant messages Receives: Behavioral: Mobile chat-based instant messages; Behavioral: Alcohol brief intervention |
| control group | Active comparator | Alcohol brief intervention Receives: Behavioral: Alcohol brief intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in unit of alcohol consumption in gram
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 3-month after baseline.
Measured: at 3-month after baseline.
Secondary outcomes (6)
change in unit of alcohol consumption in gram
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 1-month after phase I
Measured: 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"
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
Measured: 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"
Compare the frequency of drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires
Measured: 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)
Compare the attempt to reduce drinking between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires
Measured: at 1 and 3 months after phase I
change in confidence to reduce drinking measured by Likert scale (1-10)
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
Measured: at 1 and 3 months after phase I
Alcohol Problems Scale at 1 and 3-month follow-up
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
Measured: at 1 and 3 months after phase I
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2019
- Primary completion30 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Wang, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823599
- Sponsor's protocol ID
- Pilot alcohol study (AED)
- Status last verified
- Sep 2019
- First submitted
- 27 Jan 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03823599
- Acronym / sponsor ID
- Pilot alcohol study (AED)
- Conditions
- Alcohol Use Disorder
- Keywords
- chat-based intervention, alcohol brief intervention, Alcohol misuse, Accident & Emergency Department, AUDIT, instant messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mobile chat-based instant messages, Behavioral: Alcohol brief interventionAlcohol brief intervention+mobile chat-based instant messages |
| control group | Active comparator | Behavioral: Alcohol brief interventionAlcohol brief intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile chat-based instant messagesSubjects 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 | Behavioural | Intervention group |
| Alcohol brief interventionThe Control group will receive face-to-face ABI plus an alcohol leaflet from DH. | Behavioural | Intervention group, control group |
Primary outcome
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.
6 secondary outcomes
change in unit of alcohol consumption in gram
Time frame: 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
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
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
change in confidence to reduce drinking measured by Likert scale (1-10)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man Ping Wang, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile chat-based instant messages and Alcohol brief intervention in people with Alcohol Use Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in unit of alcohol consumption in gram (time frame: at 3-month after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.