Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Number of days spent hazardously drinking in the last 30 days
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of days spent hazardously drinking in the last 30 days
时间窗: Measured at 6 months post-randomization
次要结局
- Drinking-related problems(Measured at 6 months post-randomization)
- Percentage of days spent hazardously drinking in the last 30 days(Measured at 1 month post-randomization)
- App utlization(Measured at 2 weeks post-randomization)
- Number of days spent hazardously drinking in the last 30 days(Measured at 1 month post-randomization)
- Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms(Measured at 2 weeks post-randomization)
- Drinks per day over the last 30 days(Measured at 1 month post-randomization)
- Any contact with substance abuse-related health services since randomization(Measured at 2 weeks post-randomization)
- Withdrawal from study(Measured at 2 weeks post-randomization)
- Alcohol withdrawal(Measured at 2 weeks post-randomization)
- Who they have talked to about their drinking, since randomization(Measured at 2 weeks post-randomization)
- Serious adverse events(Measured at 2 weeks post-randomization)
- Loss to follow-up(Measured at 2 weeks post-randomization)
- Still experiencing any moderate-severe alcohol withdrawal signs and symptoms(Measured at 2 weeks post-randomization)
- Any contact with substance abuse-related health services since randomizations(Measured at 3 month post-randomization)
研究者
Natalie Walker
Associate Professor
University of Auckland, New Zealand