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

Alcohol Consumption Clinical Trial

— NZStepAway  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553056
• Other study ID #: U1111-1195-2467
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: December 7, 2018

Study information

• Verified date: May 2019
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 7, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

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)
• Modified NZ Step Away app
Access to 2 modules of the app (namely: drinkers profile and goals setting)

Locations

Country	Name	City	State
New Zealand	National Institute for Health Innovation, University of Auckland	Auckland

Sponsors (3)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	University of Alaska Anchorage, Waitemata District Health Board

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days spent hazardously drinking in the last 30 days		Measured at 6 months post-randomization
Secondary	Number of days spent hazardously drinking in the last 30 days		Measured at 3 months post-randomization
Secondary	Number of days spent hazardously drinking in the last 30 days		Measured at 1 month post-randomization
Secondary	Percentage of days spent hazardously drinking in the last 30 days		Measured at 6 months post-randomization
Secondary	Percentage of days spent hazardously drinking in the last 30 days		Measured at 3 months post-randomization
Secondary	Percentage of days spent hazardously drinking in the last 30 days		Measured at 1 month post-randomization
Secondary	Drinks per day over the last 30 days		Measured at 6 months post-randomization
Secondary	Drinks per day over the last 30 days		Measured at 3 months post-randomization
Secondary	Drinks per day over the last 30 days		Measured at 1 month post-randomization
Secondary	Drinking-related problems	Measured by the Short Inventory of Problems - Revised (SIP-R)	Measured at 6 months post-randomization
Secondary	Any contact with substance abuse-related health services since randomization	Measured as 'Yes' or 'No'	Measured at 6 months post-randomization
Secondary	Any contact with substance abuse-related health services since randomizations	Measured as 'Yes' or 'No'	Measured at 3 month post-randomization
Secondary	Any contact with substance abuse-related health services since randomization	Measured as 'Yes' or 'No'	Measured at 1 month post-randomization
Secondary	Any contact with substance abuse-related health services since randomization	Measured as 'Yes' or 'No'	Measured at 2 weeks post-randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Serious adverse events		Measured at 6 months post-randomization
Secondary	Serious adverse events		Measured at 3 months post-randomization
Secondary	Serious adverse events		Measured at 1 month post-randomization
Secondary	Serious adverse events		Measured at 2 weeks post-randomization
Secondary	App utlization		Measured at 6 months post-randomization
Secondary	App utlization		Measured at 3 months post-randomization
Secondary	App utlization		Measured at 1 month post-randomization
Secondary	App utlization		Measured at 2 weeks post-randomization
Secondary	Withdrawal from study		Measured at 6 months post-randomization
Secondary	Withdrawal from study		Measured at 3 months post-randomization
Secondary	Withdrawal from study		Measured at 1 month post-randomization
Secondary	Withdrawal from study		Measured at 2 weeks post-randomization
Secondary	Loss to follow-up		Measured at 6 months post-randomization
Secondary	Loss to follow-up		Measured at 3 months post-randomization
Secondary	Loss to follow-up		Measured at 1 month post-randomization
Secondary	Loss to follow-up		Measured at 2 weeks post-randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 6 months post-randomization
Secondary	Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 3 months post-randomization
Secondary	Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 1 month post-randomization
Secondary	Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 2 weeks post-randomization
Secondary	Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 6 months post-randomization
Secondary	Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 3 months post-randomization
Secondary	Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 1 month post-randomization
Secondary	Still experiencing any moderate-severe alcohol withdrawal signs and symptoms	Measured as 'Yes' or 'No'	Measured at 2 weeks post-randomization