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

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ClinicalTrials.gov Identifier: NCT03553056
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Waitemata District Health Board
University of Alaska Anchorage
Information provided by (Responsible Party):
Natalie Walker, University of Auckland, New Zealand

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

Condition or disease Intervention/treatment Phase
Alcohol Consumption Other: NZ Step Away app Other: Modified NZ Step Away app Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : December 7, 2018
Actual Study Completion Date : December 7, 2018

Arm Intervention/treatment
Experimental: Intervention
NZ Step Away app
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)

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




Primary Outcome Measures :
  1. Number of days spent hazardously drinking in the last 30 days [ Time Frame: Measured at 6 months post-randomization ]

Secondary Outcome Measures :
  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'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553056


Locations
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New Zealand
National Institute for Health Innovation, University of Auckland
Auckland, New Zealand, 1142
Sponsors and Collaborators
University of Auckland, New Zealand
Waitemata District Health Board
University of Alaska Anchorage
Investigators
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Principal Investigator: Natalie Walker, PhD University of Auckland, New Zealand

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Responsible Party: Natalie Walker, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT03553056     History of Changes
Other Study ID Numbers: U1111-1195-2467
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natalie Walker, University of Auckland, New Zealand:
alcohol
hazardous drinking
mobile phone app
clinical trial
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior