Alcohol ConsumptionNZStepAwayNCT03553056
Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
A study testing NZ Step Away app and Modified NZ Step Away app in people with Alcohol Consumption, run by University of Auckland, New Zealand at 1 site in New Zealand.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- NZ Step Away app and Modified NZ Step Away app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteNew Zealand
- Study dates
- 30 Apr 2018to 7 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
National Institute for Health Innovation, University of Auckland
Auckland, 1142
About this study
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
Read the 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.
- Conditions
- Alcohol Consumption
- Being tested
- NZ Step Away app, Modified NZ Step Away app
- Keywords
- alcohol, hazardous drinking, mobile phone app, clinical trial
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NZ Step Away appOther
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 appOther
Access to 2 modules of the app (namely: drinkers profile and goals setting)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | NZ Step Away app Receives: Other: NZ Step Away app |
| Control | Active comparator | Modified NZ Step Away app Receives: Other: Modified NZ Step Away app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days spent hazardously drinking in the last 30 days
Measured: Measured at 6 months post-randomization
Secondary outcomes (45)
Number of days spent hazardously drinking in the last 30 days
Measured: Measured at 3 months post-randomization
Number of days spent hazardously drinking in the last 30 days
Measured: Measured at 1 month post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Measured: Measured at 6 months post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Measured: Measured at 3 months post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Measured: Measured at 1 month post-randomization
Drinks per day over the last 30 days
Measured: Measured at 6 months post-randomization
Drinks per day over the last 30 days
Measured: Measured at 3 months post-randomization
Drinks per day over the last 30 days
Measured: Measured at 1 month post-randomization
Drinking-related problems
Measured by the Short Inventory of Problems - Revised (SIP-R)
Measured: Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Measured: Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomizations
Measured as 'Yes' or 'No'
Measured: Measured at 3 month post-randomization
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Measured: Measured at 1 month post-randomization
Any contact with substance abuse-related health services since randomization
Measured as 'Yes' or 'No'
Measured: 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: 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: 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: 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: Measured at 2 weeks post-randomization
Serious adverse events
Measured: Measured at 6 months post-randomization
Serious adverse events
Measured: Measured at 3 months post-randomization
Serious adverse events
Measured: Measured at 1 month post-randomization
Serious adverse events
Measured: Measured at 2 weeks post-randomization
App utlization
Measured: Measured at 6 months post-randomization
App utlization
Measured: Measured at 3 months post-randomization
App utlization
Measured: Measured at 1 month post-randomization
App utlization
Measured: Measured at 2 weeks post-randomization
Withdrawal from study
Measured: Measured at 6 months post-randomization
Withdrawal from study
Measured: Measured at 3 months post-randomization
Withdrawal from study
Measured: Measured at 1 month post-randomization
Withdrawal from study
Measured: Measured at 2 weeks post-randomization
Loss to follow-up
Measured: Measured at 6 months post-randomization
Loss to follow-up
Measured: Measured at 3 months post-randomization
Loss to follow-up
Measured: Measured at 1 month post-randomization
Loss to follow-up
Measured: 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: 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: 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: 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: Measured at 2 weeks post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 6 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 3 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 1 month post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 2 weeks post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 6 months post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 3 months post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 1 month post-randomization
Still experiencing any moderate-severe alcohol withdrawal signs and symptoms
Measured as 'Yes' or 'No'
Measured: Measured at 2 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start30 Apr 2018
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Waitemata District Health Board, University of Alaska Anchorage
- Responsible party
- Principal investigator, Natalie Walker, University of Auckland, New Zealand
- Investigators
- Natalie Walker, PhD, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553056
- Sponsor's protocol ID
- U1111-1195-2467
- Acronym
- NZStepAway
- Status last verified
- May 2019
- First submitted
- 20 May 2018
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Smart-phone Based Support System for Hazardous Drinkers
- ClinicalTrials.gov ID
- NCT03553056
- Acronym / sponsor ID
- NZStepAway / U1111-1195-2467
- Conditions
- Alcohol Consumption
- Keywords
- alcohol, hazardous drinking, mobile phone app, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Waitemata District Health Board, University of Alaska Anchorage
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: NZ Step Away appNZ Step Away app |
| Control | Active comparator | Other: Modified NZ Step Away appModified NZ Step Away app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NZ Step Away appAccess to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities) | Other | Intervention |
| Modified NZ Step Away appAccess to 2 modules of the app (namely: drinkers profile and goals setting) | Other | Control |
Primary outcome
Number of days spent hazardously drinking in the last 30 days
Time frame: Measured at 6 months post-randomization
45 secondary outcomes
Number of days spent hazardously drinking in the last 30 days
Time frame: Measured at 3 months post-randomization
Number of days spent hazardously drinking in the last 30 days
Time frame: Measured at 1 month post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Time frame: Measured at 6 months post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Time frame: Measured at 3 months post-randomization
Percentage of days spent hazardously drinking in the last 30 days
Time frame: Measured at 1 month post-randomization
Drinks per day over the last 30 days
Time frame: Measured at 6 months post-randomization
Drinks per day over the last 30 days
Time frame: Measured at 3 months post-randomization
Drinks per day over the last 30 days
Time frame: Measured at 1 month post-randomization
Drinking-related problems
Time frame: Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomization
Time frame: Measured at 6 months post-randomization
Any contact with substance abuse-related health services since randomizations
Time frame: Measured at 3 month post-randomization
Any contact with substance abuse-related health services since randomization
Time frame: Measured at 1 month post-randomization
Any contact with substance abuse-related health services since randomization
Time frame: Measured at 2 weeks post-randomization
Who they have talked to about their drinking, since randomization
Time frame: Measured at 6 months post-randomization
Who they have talked to about their drinking, since randomization
Time frame: Measured at 3 months post-randomization
Who they have talked to about their drinking, since randomization
Time frame: Measured at 1 month post-randomization
Who they have talked to about their drinking, since randomization
Time frame: Measured at 2 weeks post-randomization
Serious adverse events
Time frame: Measured at 6 months post-randomization
Serious adverse events
Time frame: Measured at 3 months post-randomization
Serious adverse events
Time frame: Measured at 1 month post-randomization
Serious adverse events
Time frame: Measured at 2 weeks post-randomization
App utlization
Time frame: Measured at 6 months post-randomization
App utlization
Time frame: Measured at 3 months post-randomization
App utlization
Time frame: Measured at 1 month post-randomization
App utlization
Time frame: Measured at 2 weeks post-randomization
Withdrawal from study
Time frame: Measured at 6 months post-randomization
Withdrawal from study
Time frame: Measured at 3 months post-randomization
Withdrawal from study
Time frame: Measured at 1 month post-randomization
Withdrawal from study
Time frame: Measured at 2 weeks post-randomization
Loss to follow-up
Time frame: Measured at 6 months post-randomization
Loss to follow-up
Time frame: Measured at 3 months post-randomization
Loss to follow-up
Time frame: Measured at 1 month post-randomization
Loss to follow-up
Time frame: Measured at 2 weeks post-randomization
Alcohol withdrawal
Time frame: Measured at 6 months post-randomization
Alcohol withdrawal
Time frame: Measured at 3 months post-randomization
Alcohol withdrawal
Time frame: Measured at 1 month post-randomization
Alcohol withdrawal
Time frame: Measured at 2 weeks post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Time frame: Measured at 6 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Time frame: Measured at 3 months post-randomization
Medical help sought for any moderate-severe alcohol withdrawal signs and symptoms
Time frame: Measured at 1 month post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
Related trials for Alcohol Consumption
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalie Walker, PhD principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NZ Step Away app and Modified NZ Step Away app in people with Alcohol Consumption, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days spent hazardously drinking in the last 30 days (time frame: Measured at 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.