NCT03553056

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2018

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 20, 2018

Last Update Submit

May 13, 2019

Conditions

Keywords

alcoholhazardous drinkingmobile phone appclinical trial

Outcome Measures

Primary Outcomes (1)

  • Number of days spent hazardously drinking in the last 30 days

    Measured at 6 months post-randomization

Secondary Outcomes (45)

  • Number of days spent hazardously drinking in the last 30 days

    Measured at 3 months post-randomization

  • Number of days spent hazardously drinking in the last 30 days

    Measured at 1 month post-randomization

  • Percentage of days spent hazardously drinking in the last 30 days

    Measured at 6 months post-randomization

  • Percentage of days spent hazardously drinking in the last 30 days

    Measured at 3 months post-randomization

  • Percentage of days spent hazardously drinking in the last 30 days

    Measured at 1 month post-randomization

  • +40 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

NZ Step Away app

Other: NZ Step Away app

Control

ACTIVE COMPARATOR

Modified NZ Step Away app

Other: Modified NZ Step Away app

Interventions

Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)

Intervention

Access to 2 modules of the app (namely: drinkers profile and goals setting)

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health Innovation, University of Auckland

Auckland, 1142, New Zealand

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Natalie Walker, PhD

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 20, 2018

First Posted

June 12, 2018

Study Start

April 30, 2018

Primary Completion

December 7, 2018

Study Completion

December 7, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations