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Completed

NCT Number: NCT03553056

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Health Innovation, University of Auckland

Auckland, 1142, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NZ Step Away app

Other

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

Other

Access to 2 modules of the app (namely: drinkers profile and goals setting)

Primary outcomes

  1. Number of days spent hazardously drinking in the last 30 days

    Time frame: Measured at 6 months post-randomization

Secondary outcomes

  1. Number of days spent hazardously drinking in the last 30 days

    Time frame: Measured at 3 months post-randomization

  2. Number of days spent hazardously drinking in the last 30 days

    Time frame: Measured at 1 month post-randomization

  3. Percentage of days spent hazardously drinking in the last 30 days

    Time frame: Measured at 6 months post-randomization

  4. Percentage of days spent hazardously drinking in the last 30 days

    Time frame: Measured at 3 months post-randomization

  5. Percentage of days spent hazardously drinking in the last 30 days

    Time frame: Measured at 1 month post-randomization

  6. Drinks per day over the last 30 days

    Time frame: Measured at 6 months post-randomization

  7. Drinks per day over the last 30 days

    Time frame: Measured at 3 months post-randomization

  8. Drinks per day over the last 30 days

    Time frame: Measured at 1 month post-randomization

  9. Drinking-related problems

    Time frame: Measured at 6 months post-randomization

    Measured by the Short Inventory of Problems - Revised (SIP-R)

  10. Any contact with substance abuse-related health services since randomization

    Time frame: Measured at 6 months post-randomization

    Measured as 'Yes' or 'No'

  11. Any contact with substance abuse-related health services since randomizations

    Time frame: Measured at 3 month post-randomization

    Measured as 'Yes' or 'No'

  12. Any contact with substance abuse-related health services since randomization

    Time frame: Measured at 1 month post-randomization

    Measured as 'Yes' or 'No'

  13. Any contact with substance abuse-related health services since randomization

    Time frame: Measured at 2 weeks post-randomization

    Measured as 'Yes' or 'No'

  14. Who they have talked to about their drinking, since randomization

    Time frame: Measured at 6 months post-randomization

    'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'

  15. Who they have talked to about their drinking, since randomization

    Time frame: Measured at 3 months post-randomization

    'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'

  16. Who they have talked to about their drinking, since randomization

    Time frame: Measured at 1 month post-randomization

    'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'

  17. Who they have talked to about their drinking, since randomization

    Time frame: Measured at 2 weeks post-randomization

    'Yes' or 'No' answers to options of 'Partner, Family, Whanau, GP/Doctor, Other'

  18. Serious adverse events

    Time frame: Measured at 6 months post-randomization

  19. Serious adverse events

    Time frame: Measured at 3 months post-randomization

  20. Serious adverse events

    Time frame: Measured at 1 month post-randomization

  21. Serious adverse events

    Time frame: Measured at 2 weeks post-randomization

  22. App utlization

    Time frame: Measured at 6 months post-randomization

  23. App utlization

    Time frame: Measured at 3 months post-randomization

  24. App utlization

    Time frame: Measured at 1 month post-randomization

  25. App utlization

    Time frame: Measured at 2 weeks post-randomization

  26. Withdrawal from study

    Time frame: Measured at 6 months post-randomization

  27. Withdrawal from study

    Time frame: Measured at 3 months post-randomization

  28. Withdrawal from study

    Time frame: Measured at 1 month post-randomization

  29. Withdrawal from study

    Time frame: Measured at 2 weeks post-randomization

  30. Loss to follow-up

    Time frame: Measured at 6 months post-randomization

  31. Loss to follow-up

    Time frame: Measured at 3 months post-randomization

  32. Loss to follow-up

    Time frame: Measured at 1 month post-randomization

  33. Loss to follow-up

    Time frame: Measured at 2 weeks post-randomization

  34. Alcohol withdrawal

    Time frame: Measured at 6 months post-randomization

    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.

  35. Alcohol withdrawal

    Time frame: Measured at 3 months post-randomization

    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.

  36. Alcohol withdrawal

    Time frame: Measured at 1 month post-randomization

    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.

  37. Alcohol withdrawal

    Time frame: Measured at 2 weeks post-randomization

    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.

  38. Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 6 months post-randomization

    Measured as 'Yes' or 'No'

  39. Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 3 months post-randomization

    Measured as 'Yes' or 'No'

  40. Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 1 month post-randomization

    Measured as 'Yes' or 'No'

  41. Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 2 weeks post-randomization

    Measured as 'Yes' or 'No'

  42. Still experiencing any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 6 months post-randomization

    Measured as 'Yes' or 'No'

  43. Still experiencing any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 3 months post-randomization

    Measured as 'Yes' or 'No'

  44. Still experiencing any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 1 month post-randomization

    Measured as 'Yes' or 'No'

  45. Still experiencing any moderate-severe alcohol withdrawal signs and symptoms

    Time frame: Measured at 2 weeks post-randomization

    Measured as 'Yes' or 'No'

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • University of Alaska Anchorage
  • Waitemata District Health Board

Registry information

Acronym: NZStepAway

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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