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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
Secondary ID [1] 0 0
U1111-1195-2467
Universal Trial Number (UTN)
Trial acronym
NZStepAway
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Consumption 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of days spent hazardously drinking in the last 30 days
Timepoint [1] 0 0
Measured at 6 months post-randomization
Secondary outcome [1] 0 0
Number of days spent hazardously drinking in the last 30 days
Timepoint [1] 0 0
Measured at 3 months post-randomization
Secondary outcome [2] 0 0
Number of days spent hazardously drinking in the last 30 days
Timepoint [2] 0 0
Measured at 1 month post-randomization
Secondary outcome [3] 0 0
Percentage of days spent hazardously drinking in the last 30 days
Timepoint [3] 0 0
Measured at 6 months post-randomization
Secondary outcome [4] 0 0
Percentage of days spent hazardously drinking in the last 30 days
Timepoint [4] 0 0
Measured at 3 months post-randomization
Secondary outcome [5] 0 0
Percentage of days spent hazardously drinking in the last 30 days
Timepoint [5] 0 0
Measured at 1 month post-randomization
Secondary outcome [6] 0 0
Drinks per day over the last 30 days
Timepoint [6] 0 0
Measured at 6 months post-randomization
Secondary outcome [7] 0 0
Drinks per day over the last 30 days
Timepoint [7] 0 0
Measured at 3 months post-randomization
Secondary outcome [8] 0 0
Drinks per day over the last 30 days
Timepoint [8] 0 0
Measured at 1 month post-randomization
Secondary outcome [9] 0 0
Drinking-related problems
Timepoint [9] 0 0
Measured at 6 months post-randomization
Secondary outcome [10] 0 0
Any contact with substance abuse-related health services since randomization
Timepoint [10] 0 0
Measured at 6 months post-randomization
Secondary outcome [11] 0 0
Any contact with substance abuse-related health services since randomizations
Timepoint [11] 0 0
Measured at 3 month post-randomization
Secondary outcome [12] 0 0
Any contact with substance abuse-related health services since randomization
Timepoint [12] 0 0
Measured at 1 month post-randomization
Secondary outcome [13] 0 0
Any contact with substance abuse-related health services since randomization
Timepoint [13] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [14] 0 0
Who they have talked to about their drinking, since randomization
Timepoint [14] 0 0
Measured at 6 months post-randomization
Secondary outcome [15] 0 0
Who they have talked to about their drinking, since randomization
Timepoint [15] 0 0
Measured at 3 months post-randomization
Secondary outcome [16] 0 0
Who they have talked to about their drinking, since randomization
Timepoint [16] 0 0
Measured at 1 month post-randomization
Secondary outcome [17] 0 0
Who they have talked to about their drinking, since randomization
Timepoint [17] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [18] 0 0
Serious adverse events
Timepoint [18] 0 0
Measured at 6 months post-randomization
Secondary outcome [19] 0 0
Serious adverse events
Timepoint [19] 0 0
Measured at 3 months post-randomization
Secondary outcome [20] 0 0
Serious adverse events
Timepoint [20] 0 0
Measured at 1 month post-randomization
Secondary outcome [21] 0 0
Serious adverse events
Timepoint [21] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [22] 0 0
App utlization
Timepoint [22] 0 0
Measured at 6 months post-randomization
Secondary outcome [23] 0 0
App utlization
Timepoint [23] 0 0
Measured at 3 months post-randomization
Secondary outcome [24] 0 0
App utlization
Timepoint [24] 0 0
Measured at 1 month post-randomization
Secondary outcome [25] 0 0
App utlization
Timepoint [25] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [26] 0 0
Withdrawal from study
Timepoint [26] 0 0
Measured at 6 months post-randomization
Secondary outcome [27] 0 0
Withdrawal from study
Timepoint [27] 0 0
Measured at 3 months post-randomization
Secondary outcome [28] 0 0
Withdrawal from study
Timepoint [28] 0 0
Measured at 1 month post-randomization
Secondary outcome [29] 0 0
Withdrawal from study
Timepoint [29] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [30] 0 0
Loss to follow-up
Timepoint [30] 0 0
Measured at 6 months post-randomization
Secondary outcome [31] 0 0
Loss to follow-up
Timepoint [31] 0 0
Measured at 3 months post-randomization
Secondary outcome [32] 0 0
Loss to follow-up
Timepoint [32] 0 0
Measured at 1 month post-randomization
Secondary outcome [33] 0 0
Loss to follow-up
Timepoint [33] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [34] 0 0
Alcohol withdrawal
Timepoint [34] 0 0
Measured at 6 months post-randomization
Secondary outcome [35] 0 0
Alcohol withdrawal
Timepoint [35] 0 0
Measured at 3 months post-randomization
Secondary outcome [36] 0 0
Alcohol withdrawal
Timepoint [36] 0 0
Measured at 1 month post-randomization
Secondary outcome [37] 0 0
Alcohol withdrawal
Timepoint [37] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [38] 0 0
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [38] 0 0
Measured at 6 months post-randomization
Secondary outcome [39] 0 0
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [39] 0 0
Measured at 3 months post-randomization
Secondary outcome [40] 0 0
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [40] 0 0
Measured at 1 month post-randomization
Secondary outcome [41] 0 0
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [41] 0 0
Measured at 2 weeks post-randomization
Secondary outcome [42] 0 0
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [42] 0 0
Measured at 6 months post-randomization
Secondary outcome [43] 0 0
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [43] 0 0
Measured at 3 months post-randomization
Secondary outcome [44] 0 0
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [44] 0 0
Measured at 1 month post-randomization
Secondary outcome [45] 0 0
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Timepoint [45] 0 0
Measured at 2 weeks post-randomization

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/12/2018
Sample size
Target
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Waitemata District Health Board
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Alaska Anchorage
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT03553056
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Walker, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03553056