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

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

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption
• Intervention / Treatment: Other: NZ Step Away app; Other: Modified NZ Step Away app

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1142
    • National Institute for Health Innovation, University of Auckland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; NZ Step Away app	Other: 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)
Active Comparator: Control; Modified NZ Step Away app	Other: Modified NZ Step Away app; Access to 2 modules of the app (namely: drinkers profile and goals setting)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days spent hazardously drinking in the last 30 days	Measured at 6 months post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Drinks per day over the last 30 days		Measured at 6 months post-randomization
Drinks per day over the last 30 days		Measured at 3 months post-randomization
Drinks per day over the last 30 days		Measured at 1 month post-randomization
Drinking-related problems	Measured by the Short Inventory of Problems - Revised (SIP-R)	Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomization	Measured as 'Yes' or 'No'	Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomizations	Measured as 'Yes' or 'No'	Measured at 3 month post-randomization
Any contact with substance abuse-related health services since randomization	Measured as 'Yes' or 'No'	Measured at 1 month post-randomization
Any contact with substance abuse-related health services since randomization	Measured as 'Yes' or 'No'	Measured at 2 weeks post-randomization
Who they have talked to about their drinking, since randomization	'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'	Measured at 6 months post-randomization
Who they have talked to about their drinking, since randomization	'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'	Measured at 3 months post-randomization
Who they have talked to about their drinking, since randomization	'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'	Measured at 1 month post-randomization
Who they have talked to about their drinking, since randomization	'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'	Measured at 2 weeks post-randomization
Serious adverse events		Measured at 6 months post-randomization
Serious adverse events		Measured at 3 months post-randomization
Serious adverse events		Measured at 1 month post-randomization
Serious adverse events		Measured at 2 weeks post-randomization
App utlization		Measured at 6 months post-randomization
App utlization		Measured at 3 months post-randomization
App utlization		Measured at 1 month post-randomization
App utlization		Measured at 2 weeks post-randomization
Withdrawal from study		Measured at 6 months post-randomization
Withdrawal from study		Measured at 3 months post-randomization
Withdrawal from study		Measured at 1 month post-randomization
Withdrawal from study		Measured at 2 weeks post-randomization
Loss to follow-up		Measured at 6 months post-randomization
Loss to follow-up		Measured at 3 months post-randomization
Loss to follow-up		Measured at 1 month post-randomization
Loss to follow-up		Measured at 2 weeks post-randomization
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.	Measured at 6 months post-randomization
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.	Measured at 3 months post-randomization
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.	Measured at 1 month post-randomization
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.	Measured at 2 weeks post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 6 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 3 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 1 month post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 2 weeks post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 6 months post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 3 months post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 1 month post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 2 weeks post-randomization

Collaborators and Investigators

• Sponsor: University of Auckland, New Zealand
• Collaborators: Waitemata District Health Board; University of Alaska Anchorage
• Investigators: Principal Investigator: Natalie Walker, PhD, University of Auckland, New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): December 7, 2018
• Study Completion (Actual): December 7, 2018

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: alcohol; clinical trial; hazardous drinking; mobile phone app
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: U1111-1195-2467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No