Clinical trial NCT03553056: Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
Official title: Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: alcohol
hazardous drinking
mobile phone app
clinical trial
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Waitemata District Health Board
name: University of Alaska Anchorage
First posted: 2018-06-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of days spent hazardously drinking in the last 30 days
timeFrame: Measured at 6 months post-randomization
Secondary outcomes:
measure: Number of days spent hazardously drinking in the last 30 days
timeFrame: Measured at 3 months post-randomization
measure: Number of days spent hazardously drinking in the last 30 days
timeFrame: Measured at 1 month post-randomization
measure: Percentage of days spent hazardously drinking in the last 30 days
timeFrame: Measured at 6 months post-randomization
measure: Percentage of days spent hazardously drinking in the last 30 days
timeFrame: Measured at 3 months post-randomization
measure: Percentage of days spent hazardously drinking in the last 30 days
timeFrame: Measured at 1 month post-randomization
measure: Drinks per day over the last 30 days
timeFrame: Measured at 6 months post-randomization
measure: Drinks per day over the last 30 days
timeFrame: Measured at 3 months post-randomization
measure: Drinks per day over the last 30 days
timeFrame: Measured at 1 month post-randomization
measure: Drinking-related problems
timeFrame: Measured at 6 months post-randomization
measure: Any contact with substance abuse-related health services since randomization
timeFrame: Measured at 6 months post-randomization
measure: Any contact with substance abuse-related health services since randomizations
timeFrame: Measured at 3 month post-randomization
measure: Any contact with substance abuse-related health services since randomization
timeFrame: Measured at 1 month post-randomization
measure: Any contact with substance abuse-related health services since randomization
timeFrame: Measured at 2 weeks post-randomization
measure: Who they have talked to about their drinking, since randomization
timeFrame: Measured at 6 months post-randomization
measure: Who they have talked to about their drinking, since randomization
timeFrame: Measured at 3 months post-randomization
measure: Who they have talked to about their drinking, since randomization
timeFrame: Measured at 1 month post-randomization
measure: Who they have talked to about their drinking, since randomization
timeFrame: Measured at 2 weeks post-randomization
measure: Serious adverse events
timeFrame: Measured at 6 months post-randomization
measure: Serious adverse events
timeFrame: Measured at 3 months post-randomization
measure: Serious adverse events
timeFrame: Measured at 1 month post-randomization
measure: Serious adverse events
timeFrame: Measured at 2 weeks post-randomization
measure: App utlization
timeFrame: Measured at 6 months post-randomization
measure: App utlization
timeFrame: Measured at 3 months post-randomization
measure: App utlization
timeFrame: Measured at 1 month post-randomization
measure: App utlization
timeFrame: Measured at 2 weeks post-randomization
measure: Withdrawal from study
timeFrame: Measured at 6 months post-randomization
measure: Withdrawal from study
timeFrame: Measured at 3 months post-randomization
measure: Withdrawal from study
timeFrame: Measured at 1 month post-randomization
measure: Withdrawal from study
timeFrame: Measured at 2 weeks post-randomization
measure: Loss to follow-up
timeFrame: Measured at 6 months post-randomization
measure: Loss to follow-up
timeFrame: Measured at 3 months post-randomization
measure: Loss to follow-up
timeFrame: Measured at 1 month post-randomization
measure: Loss to follow-up
timeFrame: Measured at 2 weeks post-randomization
measure: Alcohol withdrawal
timeFrame: Measured at 6 months post-randomization
measure: Alcohol withdrawal
timeFrame: Measured at 3 months post-randomization
measure: Alcohol withdrawal
timeFrame: Measured at 1 month post-randomization
measure: Alcohol withdrawal
timeFrame: Measured at 2 weeks post-randomization
measure: Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 6 months post-randomization
measure: Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 3 months post-randomization
measure: Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 1 month post-randomization
measure: Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 2 weeks post-randomization
measure: Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 6 months post-randomization
measure: Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 3 months post-randomization
measure: Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 1 month post-randomization
measure: Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
timeFrame: Measured at 2 weeks post-randomization
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: National Institute for Health Innovation, University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: Natalie Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: