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Feasibility of a Smart-phone Based Support System for Hazardous Drinkers (NZStepAway)

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
NZ Step Away app
Modified NZ Step Away app
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Consumption focused on measuring alcohol, hazardous drinking, mobile phone app, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • reside in Auckland, New Zealand
  • at least 18 years of age
  • have access to a smartphone
  • report that they currently drink alcohol
  • have had at least two episodes of binge drinking (defined as six or more drinks on one occasion) in the past 30 days
  • meet the criteria for hazardous drinking (i.e. 8-19 on the AUDIT)
  • express motivation to moderate or abstain from drinking.

Exclusion Criteria:

  • Identified during screening as having moderate to severe alcohol dependence (≥20 score on the AUDIT)
  • Currently enrolled in an alcohol programme
  • Another person in the household is already a participant.

Sites / Locations

  • National Institute for Health Innovation, University of Auckland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

NZ Step Away app

Modified NZ Step Away app

Outcomes

Primary Outcome Measures

Number of days spent hazardously drinking in the last 30 days

Secondary Outcome Measures

Number of days spent hazardously drinking in the last 30 days
Number of days spent hazardously drinking in the last 30 days
Percentage of days spent hazardously drinking in the last 30 days
Percentage of days spent hazardously drinking in the last 30 days
Percentage of days spent hazardously drinking in the last 30 days
Drinks per day over the last 30 days
Drinks per day over the last 30 days
Drinks per day over the last 30 days
Drinking-related problems
Measured by the Short Inventory of Problems - Revised (SIP-R)
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Any contact with substance abuse-related health services since randomizations
Measured as 'Yes' or 'No'
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Who they have talked to about their drinking, since randomization
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Serious adverse events
Serious adverse events
Serious adverse events
Serious adverse events
App utlization
App utlization
App utlization
App utlization
Withdrawal from study
Withdrawal from study
Withdrawal from study
Withdrawal from study
Loss to follow-up
Loss to follow-up
Loss to follow-up
Loss to follow-up
Alcohol withdrawal
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Alcohol withdrawal
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Alcohol withdrawal
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Alcohol withdrawal
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'

Full Information

First Posted
May 20, 2018
Last Updated
May 13, 2019
Sponsor
University of Auckland, New Zealand
Collaborators
Waitemata District Health Board, University of Alaska Anchorage
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1. Study Identification

Unique Protocol Identification Number
NCT03553056
Brief Title
Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
Acronym
NZStepAway
Official Title
Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
December 7, 2018 (Actual)
Study Completion Date
December 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand
Collaborators
Waitemata District Health Board, University of Alaska Anchorage

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A feasibility trial to determine whether six months access to the New Zealand 'Step Away' app can reduce the frequency of alcohol abuse and increase engagement with substance abuse-related health services by hazardous drinkers
Detailed Description
Rationale: Hazardous drinking is an established drinking pattern that carries a risk of harming the drinker's physical and psychological health, and/or having a harmful social effect on the drinker, their families and the community. Interventions to support people who are drinking at hazardous levels are proven to be beneficial and cost-effective at both individual and population levels. However, very few people report having received help to reduce their alcohol consumption, despite support being available. Those who do seek help predominantly talk to their GP first, who then refers them for specialist support. Consequently, there remains a significant gap between the population 'in need' of treatment and those actually engaged in treatment. Mobile-phone based alcohol interventions have the potential to function as a stand-alone intervention to help people address their alcohol problem, and/or act as a conduit to more intensive treatment. 'Step Away' is a smartphone-delivered health intervention designed in the USA to help individuals moderate or abstain completely from drinking alcohol. It is the only alcohol-related mobile app whose development was informed by an empirically-supported intervention grounded in a psychological theory. While the app has shown promise in a North American sample, a well-powered clinical trial of the intervention has yet to be undertaken. In its current form the app is not suitable for adoption in New Zealand as it uses North American drinking norms and safe drinking guidelines, numerous "Americanisms" and the imperial measurement system, and it focuses on US care services. However, a New Zealand version of 'Step Away' could easily be developed, with input from New Zealand stakeholders and end-users. Aims: To 1) adapt the "Step Away' app for New Zealand, then 2) undertake a feasibility study to determine whether six months access to the app can reduce the frequency of alcohol abuse and increase engagement with substance abuse-related health services in adult, hazardous drinkers in Auckland. Design: Double-blind, randomised-controlled trial. Recruitment: Community advertising, including social media. Sample size: As a feasibility study, no sample size calculation was undertaken. However, 200 people (100 in each arm) will provide sufficient data to ascertain the direction and likely effect size for the various alcohol-related outcomes, the likely recruitment rate, and estimates around participant retention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
alcohol, hazardous drinking, mobile phone app, clinical trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
NZ Step Away app
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Modified NZ Step Away app
Intervention Type
Other
Intervention Name(s)
NZ Step Away app
Intervention Description
Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)
Intervention Type
Other
Intervention Name(s)
Modified NZ Step Away app
Intervention Description
Access to 2 modules of the app (namely: drinkers profile and goals setting)
Primary Outcome Measure Information:
Title
Number of days spent hazardously drinking in the last 30 days
Time Frame
Measured at 6 months post-randomization
Secondary Outcome Measure Information:
Title
Number of days spent hazardously drinking in the last 30 days
Time Frame
Measured at 3 months post-randomization
Title
Number of days spent hazardously drinking in the last 30 days
Time Frame
Measured at 1 month post-randomization
Title
Percentage of days spent hazardously drinking in the last 30 days
Time Frame
Measured at 6 months post-randomization
Title
Percentage of days spent hazardously drinking in the last 30 days
Time Frame
Measured at 3 months post-randomization
Title
Percentage of days spent hazardously drinking in the last 30 days
Time Frame
Measured at 1 month post-randomization
Title
Drinks per day over the last 30 days
Time Frame
Measured at 6 months post-randomization
Title
Drinks per day over the last 30 days
Time Frame
Measured at 3 months post-randomization
Title
Drinks per day over the last 30 days
Time Frame
Measured at 1 month post-randomization
Title
Drinking-related problems
Description
Measured by the Short Inventory of Problems - Revised (SIP-R)
Time Frame
Measured at 6 months post-randomization
Title
Any contact with substance abuse-related health services since randomization
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 6 months post-randomization
Title
Any contact with substance abuse-related health services since randomizations
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 3 month post-randomization
Title
Any contact with substance abuse-related health services since randomization
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 1 month post-randomization
Title
Any contact with substance abuse-related health services since randomization
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 2 weeks post-randomization
Title
Who they have talked to about their drinking, since randomization
Description
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time Frame
Measured at 6 months post-randomization
Title
Who they have talked to about their drinking, since randomization
Description
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time Frame
Measured at 3 months post-randomization
Title
Who they have talked to about their drinking, since randomization
Description
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time Frame
Measured at 1 month post-randomization
Title
Who they have talked to about their drinking, since randomization
Description
'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
Time Frame
Measured at 2 weeks post-randomization
Title
Serious adverse events
Time Frame
Measured at 6 months post-randomization
Title
Serious adverse events
Time Frame
Measured at 3 months post-randomization
Title
Serious adverse events
Time Frame
Measured at 1 month post-randomization
Title
Serious adverse events
Time Frame
Measured at 2 weeks post-randomization
Title
App utlization
Time Frame
Measured at 6 months post-randomization
Title
App utlization
Time Frame
Measured at 3 months post-randomization
Title
App utlization
Time Frame
Measured at 1 month post-randomization
Title
App utlization
Time Frame
Measured at 2 weeks post-randomization
Title
Withdrawal from study
Time Frame
Measured at 6 months post-randomization
Title
Withdrawal from study
Time Frame
Measured at 3 months post-randomization
Title
Withdrawal from study
Time Frame
Measured at 1 month post-randomization
Title
Withdrawal from study
Time Frame
Measured at 2 weeks post-randomization
Title
Loss to follow-up
Time Frame
Measured at 6 months post-randomization
Title
Loss to follow-up
Time Frame
Measured at 3 months post-randomization
Title
Loss to follow-up
Time Frame
Measured at 1 month post-randomization
Title
Loss to follow-up
Time Frame
Measured at 2 weeks post-randomization
Title
Alcohol withdrawal
Description
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Time Frame
Measured at 6 months post-randomization
Title
Alcohol withdrawal
Description
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Time Frame
Measured at 3 months post-randomization
Title
Alcohol withdrawal
Description
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Time Frame
Measured at 1 month post-randomization
Title
Alcohol withdrawal
Description
Experience of any specific signs and symptoms (i.e. shakiness, sweating, vomiting, fast heart rate, mild fever, seizures, seeing or hearing things that others do not, confusion, shivering, other) since randomization, that may be due to changing the amount of alcohol consumed. Recorded as: not at all, mild, moderate, severe.
Time Frame
Measured at 2 weeks post-randomization
Title
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 6 months post-randomization
Title
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 3 months post-randomization
Title
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 1 month post-randomization
Title
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 2 weeks post-randomization
Title
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 6 months post-randomization
Title
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 3 months post-randomization
Title
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 1 month post-randomization
Title
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Description
Measured as 'Yes' or 'No'
Time Frame
Measured at 2 weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: reside in Auckland, New Zealand at least 18 years of age have access to a smartphone report that they currently drink alcohol have had at least two episodes of binge drinking (defined as six or more drinks on one occasion) in the past 30 days meet the criteria for hazardous drinking (i.e. 8-19 on the AUDIT) express motivation to moderate or abstain from drinking. Exclusion Criteria: Identified during screening as having moderate to severe alcohol dependence (≥20 score on the AUDIT) Currently enrolled in an alcohol programme Another person in the household is already a participant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Walker, PhD
Organizational Affiliation
University of Auckland, New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute for Health Innovation, University of Auckland
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility of a Smart-phone Based Support System for Hazardous Drinkers

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