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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03553056
Registration number
NCT03553056
Ethics application status
Date submitted
20/05/2018
Date registered
12/06/2018
Date last updated
15/05/2019
Titles & IDs
Public title
Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
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Scientific title
Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
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Secondary ID [1]
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U1111-1195-2467
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Universal Trial Number (UTN)
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Trial acronym
NZStepAway
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Consumption
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NZ Step Away app
Other interventions - Modified NZ Step Away app
Experimental: Intervention - NZ Step Away app
Active Comparator: Control - Modified NZ Step Away app
Other interventions: NZ Step Away app
Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)
Other interventions: Modified NZ Step Away app
Access to 2 modules of the app (namely: drinkers profile and goals setting)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of days spent hazardously drinking in the last 30 days
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Assessment method [1]
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Timepoint [1]
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Measured at 6 months post-randomization
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Secondary outcome [1]
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Number of days spent hazardously drinking in the last 30 days
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Assessment method [1]
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Timepoint [1]
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Measured at 3 months post-randomization
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Secondary outcome [2]
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Number of days spent hazardously drinking in the last 30 days
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Assessment method [2]
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Timepoint [2]
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Measured at 1 month post-randomization
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Secondary outcome [3]
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Percentage of days spent hazardously drinking in the last 30 days
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Assessment method [3]
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Timepoint [3]
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Measured at 6 months post-randomization
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Secondary outcome [4]
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Percentage of days spent hazardously drinking in the last 30 days
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Assessment method [4]
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Timepoint [4]
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Measured at 3 months post-randomization
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Secondary outcome [5]
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Percentage of days spent hazardously drinking in the last 30 days
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Assessment method [5]
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Timepoint [5]
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Measured at 1 month post-randomization
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Secondary outcome [6]
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Drinks per day over the last 30 days
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Assessment method [6]
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Timepoint [6]
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Measured at 6 months post-randomization
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Secondary outcome [7]
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Drinks per day over the last 30 days
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Assessment method [7]
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Timepoint [7]
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Measured at 3 months post-randomization
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Secondary outcome [8]
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Drinks per day over the last 30 days
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Assessment method [8]
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Timepoint [8]
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Measured at 1 month post-randomization
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Secondary outcome [9]
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Drinking-related problems
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Assessment method [9]
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Measured by the Short Inventory of Problems - Revised (SIP-R)
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Timepoint [9]
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Measured at 6 months post-randomization
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Secondary outcome [10]
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Any contact with substance abuse-related health services since randomization
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Assessment method [10]
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Measured as 'Yes' or 'No'
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Timepoint [10]
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Measured at 6 months post-randomization
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Secondary outcome [11]
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Any contact with substance abuse-related health services since randomizations
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Assessment method [11]
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Measured as 'Yes' or 'No'
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Timepoint [11]
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Measured at 3 month post-randomization
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Secondary outcome [12]
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Any contact with substance abuse-related health services since randomization
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Assessment method [12]
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Measured as 'Yes' or 'No'
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Timepoint [12]
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Measured at 1 month post-randomization
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Secondary outcome [13]
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Any contact with substance abuse-related health services since randomization
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Assessment method [13]
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Measured as 'Yes' or 'No'
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Timepoint [13]
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Measured at 2 weeks post-randomization
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Secondary outcome [14]
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Who they have talked to about their drinking, since randomization
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Assessment method [14]
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'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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Timepoint [14]
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Measured at 6 months post-randomization
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Secondary outcome [15]
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Who they have talked to about their drinking, since randomization
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Assessment method [15]
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'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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Timepoint [15]
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Measured at 3 months post-randomization
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Secondary outcome [16]
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Who they have talked to about their drinking, since randomization
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Assessment method [16]
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'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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Timepoint [16]
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Measured at 1 month post-randomization
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Secondary outcome [17]
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Who they have talked to about their drinking, since randomization
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Assessment method [17]
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'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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Timepoint [17]
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Measured at 2 weeks post-randomization
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Secondary outcome [18]
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Serious adverse events
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Assessment method [18]
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Timepoint [18]
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Measured at 6 months post-randomization
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Secondary outcome [19]
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Serious adverse events
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Assessment method [19]
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Timepoint [19]
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Measured at 3 months post-randomization
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Secondary outcome [20]
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Serious adverse events
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Assessment method [20]
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Timepoint [20]
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Measured at 1 month post-randomization
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Secondary outcome [21]
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Serious adverse events
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Assessment method [21]
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Timepoint [21]
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Measured at 2 weeks post-randomization
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Secondary outcome [22]
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App utlization
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Assessment method [22]
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Timepoint [22]
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Measured at 6 months post-randomization
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Secondary outcome [23]
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App utlization
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Assessment method [23]
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Timepoint [23]
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Measured at 3 months post-randomization
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Secondary outcome [24]
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App utlization
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Assessment method [24]
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Timepoint [24]
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Measured at 1 month post-randomization
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Secondary outcome [25]
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App utlization
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Assessment method [25]
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Timepoint [25]
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Measured at 2 weeks post-randomization
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Secondary outcome [26]
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Withdrawal from study
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Assessment method [26]
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Timepoint [26]
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Measured at 6 months post-randomization
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Secondary outcome [27]
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Withdrawal from study
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Assessment method [27]
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Timepoint [27]
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Measured at 3 months post-randomization
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Secondary outcome [28]
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Withdrawal from study
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Assessment method [28]
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Timepoint [28]
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Measured at 1 month post-randomization
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Secondary outcome [29]
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Withdrawal from study
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Assessment method [29]
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Timepoint [29]
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Measured at 2 weeks post-randomization
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Secondary outcome [30]
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Loss to follow-up
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Assessment method [30]
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Timepoint [30]
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Measured at 6 months post-randomization
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Secondary outcome [31]
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Loss to follow-up
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Assessment method [31]
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Timepoint [31]
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Measured at 3 months post-randomization
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Secondary outcome [32]
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Loss to follow-up
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Assessment method [32]
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Timepoint [32]
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Measured at 1 month post-randomization
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Secondary outcome [33]
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Loss to follow-up
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Assessment method [33]
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Timepoint [33]
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Measured at 2 weeks post-randomization
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Secondary outcome [34]
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Alcohol withdrawal
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Assessment method [34]
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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.
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Timepoint [34]
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Measured at 6 months post-randomization
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Secondary outcome [35]
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Alcohol withdrawal
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Assessment method [35]
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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.
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Timepoint [35]
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Measured at 3 months post-randomization
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Secondary outcome [36]
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Alcohol withdrawal
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Assessment method [36]
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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.
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Timepoint [36]
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Measured at 1 month post-randomization
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Secondary outcome [37]
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Alcohol withdrawal
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Assessment method [37]
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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.
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Timepoint [37]
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Measured at 2 weeks post-randomization
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Secondary outcome [38]
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Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [38]
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Measured as 'Yes' or 'No'
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Timepoint [38]
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Measured at 6 months post-randomization
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Secondary outcome [39]
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Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [39]
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Measured as 'Yes' or 'No'
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Timepoint [39]
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Measured at 3 months post-randomization
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Secondary outcome [40]
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Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [40]
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Measured as 'Yes' or 'No'
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Timepoint [40]
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Measured at 1 month post-randomization
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Secondary outcome [41]
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Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [41]
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Measured as 'Yes' or 'No'
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Timepoint [41]
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Measured at 2 weeks post-randomization
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Secondary outcome [42]
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Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [42]
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Measured as 'Yes' or 'No'
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Timepoint [42]
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Measured at 6 months post-randomization
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Secondary outcome [43]
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Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [43]
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Measured as 'Yes' or 'No'
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Timepoint [43]
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Measured at 3 months post-randomization
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Secondary outcome [44]
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Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [44]
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Measured as 'Yes' or 'No'
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Timepoint [44]
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Measured at 1 month post-randomization
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Secondary outcome [45]
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Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
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Assessment method [45]
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Measured as 'Yes' or 'No'
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Timepoint [45]
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Measured at 2 weeks post-randomization
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/12/2018
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Sample size
Target
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Accrual to date
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Final
114
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Waitemata District Health Board
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Alaska Anchorage
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03553056
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Natalie Walker, PhD
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Address
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University of Auckland, New Zealand
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03553056
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