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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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 - Measured by the Short Inventory of Problems - Revised (SIP-R)
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - 'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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 - 'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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 - 'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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 - 'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'
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 - 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.
Timepoint [34] 0 0
Measured at 6 months post-randomization
Secondary outcome [35] 0 0
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.
Timepoint [35] 0 0
Measured at 3 months post-randomization
Secondary outcome [36] 0 0
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.
Timepoint [36] 0 0
Measured at 1 month post-randomization
Secondary outcome [37] 0 0
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.
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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 - Measured as 'Yes' or 'No'
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
Gender
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
Supportive Care
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Other
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/show/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
Other publications