<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03823599</url>
  </required_header>
  <id_info>
    <org_study_id>Pilot alcohol study (AED)</org_study_id>
    <nct_id>NCT03823599</nct_id>
  </id_info>
  <brief_title>Alcohol Brief Intervention Plus Personalized Mobile Chat-based Intervention to Reduce Alcohol Misuse in an Emergency Department</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen Mary Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project focuses on patients in AED. Objectives of this project are:&#xD;
&#xD;
        1. To examine the factors associated with alcohol drinking and alcohol use disorder&#xD;
&#xD;
        2. To examine the effect of face-to-face alcohol brief intervention on drinking reduction&#xD;
&#xD;
        3. To examine the effect of a continuous interactive chat-based intervention via &quot;WhatsApp&quot;&#xD;
           on drinking reduction&#xD;
&#xD;
        4. To explore the perception of face-to-face alcohol brief intervention&#xD;
&#xD;
        5. To explore the perception of continuous interactive chat-based intervention via instant&#xD;
           messaging mobile application &quot;WhatsApp&quot;&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the Department of Health, a local epidemiological study was conducted in 2001&#xD;
      and showed that about one in ten of all motor vehicle deaths were associated with alcohol&#xD;
      consumption. Also, the statistics from the Transportation department showed that 874 vehicle&#xD;
      accidents resulting in personal injury were related to alcohol misuse, which included 24&#xD;
      fatal cases between the period of 2000 and 2010. With the aforementioned statistics&#xD;
      supported, the hospital Accident and Emergency Department (AED) serves as the most important&#xD;
      entrance and safeguard to the healthcare system for the public, since victims of traffic&#xD;
      accidents or violence related to heavy drinking are frequently encountered in AED, this&#xD;
      serves as an ideal place for provision of initial alcohol intervention and further&#xD;
      stabilization related to alcohol problem of patients. Although AED is a hectic environment&#xD;
      with very high patients turnover, substantial evidence had shown feasibility and efficacy of&#xD;
      Alcohol Brief Intervention (ABI) in reducing patients' subsequent alcohol drinking. In&#xD;
      oversea, multiple research had been done to show ABI were effective and feasible for reducing&#xD;
      alcohol misuse, but the effect was not long lasting and lead to subsequent relapse. In&#xD;
      addition to this, no further trial has been done to investigate the feasibility of&#xD;
      implementing an RCT on evaluating the effect of ABI and continuous chat-based intervention on&#xD;
      reducing alcohol consumption among patients in AED in Hong Kong.&#xD;
&#xD;
      According to the WHO, the standard ABI approach includes: giving feedback and information&#xD;
      about the screening result and hazard of drinking; emphasizing the benefits of quit drinking&#xD;
      and informing about alcohol problems; setting goal on reducing alcohol consumption; reviewing&#xD;
      advice and ; giving encouragement. In this pilot study, a brief alcohol counselling using&#xD;
      face-to-face ABI will be delivered together with continuous interactive chat-based&#xD;
      intervention via instant messaging mobile application &quot;WhatsApp&quot; to those patients with AUDIT&#xD;
      score ≥ 8, who are considered to have hazardous and harmful drinking problems according to&#xD;
      the guideline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in unit of alcohol consumption in gram</measure>
    <time_frame>at 3-month after baseline.</time_frame>
    <description>Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 3-month after baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in unit of alcohol consumption in gram</measure>
    <time_frame>at 1-month after phase I</time_frame>
    <description>Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 1-month after phase I</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in episode of binge drinking measured by asking &quot;Never&quot;, &quot;less than a month&quot;, &quot;two to four times a month&quot;, &quot; two to three times a week&quot; and &quot;almost everyday&quot;</measure>
    <time_frame>at 1 and 3 months after phase I</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in frequency of drinking by asking &quot;Never&quot;, &quot;less than a month&quot;, &quot;two to four times a month&quot;, &quot; two to three times a week&quot; and &quot;almost everyday&quot;</measure>
    <time_frame>at 1 and 3 months after phase I</time_frame>
    <description>Compare the frequency of drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>attempt to reduce drinking measured by asking whether they have tried to reduce drinking at past month (yes or no)</measure>
    <time_frame>at 1 and 3 months after phase I</time_frame>
    <description>Compare the attempt to reduce drinking between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in confidence to reduce drinking measured by Likert scale (1-10)</measure>
    <time_frame>at 1 and 3 months after phase I</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Problems Scale at 1 and 3-month follow-up</measure>
    <time_frame>at 1 and 3 months after phase I</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Alcohol Use Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alcohol brief intervention+mobile chat-based instant messages</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Alcohol brief intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mobile chat-based instant messages</intervention_name>
    <description>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</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alcohol brief intervention</intervention_name>
    <description>The Control group will receive face-to-face ABI plus an alcohol leaflet from DH.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hong Kong resident aged 18 to 65&#xD;
&#xD;
          2. scored ≥ 8 in the Alcohol Use Disorder Identification Test (AUDIT) in the past 12&#xD;
             months&#xD;
&#xD;
          3. able to communicate in Cantonese (including reading Chinese)&#xD;
&#xD;
          4. using a phone with instant messaging mobile application &quot;WhatsApp&quot; installed for&#xD;
             communication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients with communication barrier (either physically or cognitively)&#xD;
&#xD;
          2. currently participating in other alcohol treatment services or clinics&#xD;
&#xD;
          3. will be hospitalized immediate after A&amp;E consultation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Man Ping Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Nursing, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>000000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Wang Man-Ping</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>chat-based intervention</keyword>
  <keyword>alcohol brief intervention</keyword>
  <keyword>Alcohol misuse</keyword>
  <keyword>Accident &amp; Emergency Department</keyword>
  <keyword>AUDIT</keyword>
  <keyword>instant messaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03823599
org study id: Pilot alcohol study (AED)
nct id: NCT03823599
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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. To examine the effect of a continuous interactive chat-based intervention via "WhatsApp"
           on drinking reduction

        4. To explore the perception of face-to-face alcohol brief intervention

        5. To explore the perception of continuous interactive chat-based intervention via instant
           messaging mobile application "WhatsApp"
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in unit of alcohol consumption in gram
time frame: at 3-month after baseline.
description: Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 3-month after baseline.
measure: change in unit of alcohol consumption in gram
time frame: at 1-month after phase I
description: Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 1-month after phase I
measure: 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
description: 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
measure: 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
description: Compare the frequency of drinking between intervention group and control at baseline, 1 and 3-month follow-up questionnaires
measure: 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
description: Compare the attempt to reduce drinking between intervention group and control group at baseline, 1 and 3-month follow-up questionnaires
measure: change in confidence to reduce drinking measured by Likert scale (1-10)
time frame: at 1 and 3 months after phase I
description: 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
measure: Alcohol Problems Scale at 1 and 3-month follow-up
time frame: at 1 and 3 months after phase I
description: 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
arm group label: Intervention group
arm group type: Experimental
description: Alcohol brief intervention+mobile chat-based instant messages
arm group label: control group
arm group type: Active Comparator
description: Alcohol brief intervention
intervention type: Behavioral
intervention name: Mobile chat-based instant messages
description: 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
arm group label: Intervention group
intervention type: Behavioral
intervention name: Alcohol brief intervention
description: The Control group will receive face-to-face ABI plus an alcohol leaflet from DH.
arm group label: Intervention group
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Man Ping Wang, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Wang Man-Ping
investigator title: Assistant Professor
mesh term: Emergencies
mesh term: Alcoholism
sharing ipd: Undecided