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

Study Overview
=================
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.

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

Conditions
-----------------
Alcohol Consumption

Intervention / Treatment
-----------------
* Other: NZ Step Away app
* Other: Modified NZ Step Away app


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>NZ Step Away app | Other: NZ Step Away app<br>* Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)<br>|
| Active Comparator: Control<br>Modified NZ Step Away app | Other: Modified NZ Step Away app<br>* Access to 2 modules of the app (namely: drinkers profile and goals setting)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol, hazardous drinking, mobile phone app, clinical trial