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Trial registered on ANZCTR


Registration number
ACTRN12621000292875
Ethics application status
Approved
Date submitted
4/02/2021
Date registered
16/03/2021
Date last updated
4/08/2023
Date data sharing statement initially provided
16/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an internet-delivered program for risky alcohol use in older adults
Scientific title
A randomised controlled trial to evaluate whether an internet-delivered intervention for risky alcohol use in older adults (60-75 years) is effective in reducing alcohol consumption and cognitive decline
Secondary ID [1] 303309 0
RG180842
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hazardous and harmful alcohol use 320532 0
Condition category
Condition code
Mental Health 318390 318390 0 0
Addiction
Public Health 318435 318435 0 0
Health service research
Public Health 318436 318436 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention program is based upon an internet-delivered alcohol treatment program developed in the UK (Down Your Drink; www.downyourdrink.org.uk). The intervention is currently being adapted for an older Australian audience and includes educational content and personalised feedback regarding alcohol consumption and related harms, as well as several online tools and exercises designed to facilitate behaviour change. Online tools include a ‘thinking drinking diary’, allowing users to record their alcohol consumption and associated emotional and behavioural triggers; a standard drinks calculator; and a tool for recording episodes of heavy episodic drinking. The intervention includes four treatment modules in total and progresses through three distinct phases: 1) decision making (Module 1, ‘Should I cut down?’ and Module 2, ‘Planning to cut down’); 2) implementing change (Module 3, ‘Cutting down’); and 3) relapse prevention (Module 4, ‘Staying on track’). Phase 1 (Modules 1-2) is based on the principles of motivational enhancement therapy, Phase 2 (Module 3) on the principles of cognitive behavioural therapy and behavioural self-control and Phase 3 (Module 4) on best practice principles of relapse prevention.

Participants enrolled in the intervention program will be provided with individual log-ons for the website. They will access the program on their own home computer and will be free to progress through the program at their own pace. The time taken to read through and complete all tasks once is anticipated to be approximately 45 minutes for each module. However, participants can complete as few or as many components and modules as they wish and will be able to review previous modules and repeat previous tasks at any time within the 4 week active enrolment period.

While participants are free to engage with the program at their own pace, email reminders will be sent to participants who do not complete at least one module per week. After the period of active enrolment, participants in the intervention condition will be allowed to engage with the online program without restriction. User engagement data, including number of logins, time spent on the website, number of pages viewed, and number of modules completed, will be automatically collected and taken into account at the analysis stage.
Intervention code [1] 319615 0
Treatment: Other
Intervention code [2] 319889 0
Behaviour
Comparator / control treatment
Participants in the active control condition will receive the online Alcohol: The Facts booklet provided by New South Wales Health (https://bit.ly/2LwZw5P). This is an 8-page online patient information booklet, which provides information regarding the effects of alcohol consumption, alcohol dependence, associated health risks and harm minimisation strategies, as well as contact details for numerous helplines and links to additional informational websites. Participants in the control condition will be emailed a hyperlink to the online information booklet after completing baseline assessments. Reminders to read the booklet will be emailed weekly, throughout the active enrolment period, or until participants indicate that they have read the booklet by clicking a button embedded in the reminder emails. Time spent engaging with the information booklet will be at the discretion of participants. Click tracking will be used to record each time participants click on the hyperlink to the online patient information booklet. Control participants will be free to access the information booklet throughout the 12-month follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 326371 0
Total number of weekly standard drinks assessed using the online Time-Line Follow-Back (TLFB) calendar-based assessment tool for the measurement of alcohol consumption.
Timepoint [1] 326371 0
Baseline, 4 weeks and 12 months (primary timepoint) post commencement of intervention
Primary outcome [2] 326372 0
Cognition, including the following cognitive domains: complex attention (assessed using CogState Detection and CogState Identification); executive function (assessed using CogState One Back, Cambridge Brain Sciences [CBS] Spatial Search and CBS Grammatical Reasoning); learning and memory (assessed using Cogstate One Card Learning task and CBS Paired Associates test). The main outcome variable will be a global cognition composite score.
Timepoint [2] 326372 0
Baseline, 4 weeks and 12 months (primary timepoint) post commencement of intervention
Secondary outcome [1] 391225 0
Total number of drinks per drinking day, over the past month, assessed using the online TLFB
Timepoint [1] 391225 0
Baseline, 4 weeks and 12 months post commencement of intervention
Secondary outcome [2] 391226 0
Number of heavy episodic drinking days, over the past month, assessed using the online TLFB
Timepoint [2] 391226 0
Baseline, 4 weeks and 12 months post commencement of intervention
Secondary outcome [3] 391227 0
Alcohol-related harms assessed using the Alcohol Short Index of Problems (SIP), with an additional question assessing alcohol-related blackouts.
Timepoint [3] 391227 0
Baseline, 4 weeks and 12 months post commencement of intervention
Secondary outcome [4] 391228 0
Quality of life assessed using an online version of the 12-item World Health Organisation Disability Assessment Schedule II (WHODAS-II])
Timepoint [4] 391228 0
Baseline, 4 weeks and 12 months post commencement of intervention
Secondary outcome [5] 392535 0
Nonmemory-based subjective cognitive complaints assessed using nonmemory-based items from an 18-item subjective cognitive complaints questionnaire developed by researchers at the Centre for Healthy Brain Ageing.
Timepoint [5] 392535 0
Baseline, 4 weeks and 12 months post commencement of intervention.
Secondary outcome [6] 392836 0
Memory-based subjective cognitive complaints assessed using the Memory Complaint Questionnaire (MAC-Q), as well as memory-based items from an 18-item subjective cognitive complaints questionnaire developed by researchers at the Centre for Healthy Brain Ageing.
Timepoint [6] 392836 0
Baseline, 4 weeks and 12 months post commencement of intervention.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion in the study if they are 60 to 75 years old; meet the criteria for hazardous or harmful drinking (Alcohol Use Disorder Identification Test [AUDIT] score greater than or equal to 8); have access to a home computer, email account and the Internet; and are based in Australia.
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: diagnosis of a neurological disorder (e.g. dementia, Parkinson’s disease, multiple sclerosis); having ever been prescribed medication for the treatment of Alzheimer’s disease; uncorrected visual impairment; inability to use a mouse/keyboard without assistance; the presence of a severe physical illness or life-threatening condition; having been held in hospital overnight (at least 24h) 6 or more times in the last 12-months; having had surgery requiring general anaesthesia in the last 3-months; having suffered a heart attack or stroke in the last 3-months; having ever been diagnosed with brain cancer; an active psychological condition requiring inpatient treatment or antipsychotic medication; involvement in another treatment program for alcohol use; having ever experienced a seizure as a consequence of alcohol withdrawal; having ever experienced delirium tremens as a consequence of alcohol withdrawal; and inability to read and write in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Allocation will involve contacting the holder of the allocation schedule who will be "off-site" or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Enrolled participants will be randomised to one of the two participant groups according to a sequence generated by the online true random number service, random.org, stratified by age (60-64; 65–69; 70-75) and sex.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For a sample of 90% power with a 0.1 standardised between-group mean difference (p<0.05) on cognition and alcohol scores, a total sample size of 842 (n=421 per arm) is needed. This calculation takes into account the fact the outcomes are being assessed at three occasions and assumes that each assessment will be correlated with the next at 0.6.

Hypothesised intervention effects will be examined using linear mixed model regression analysis which takes into account the correlated nature of the repeated measurements within participants over time. Models will be adjusted for baseline differences. Bonferroni adjustments will be made to control for multiple comparisons. Strategies will be used to examine the impact of attrition, including multiple imputation and regression weighting. Sensitivity analyses will be conducted to assess the effect of attrition on inferences drawn from target parameters in statistical analyses. Engagement with the internet-delivered intervention will be evaluated through descriptive statistics based on multiple engagement measures, including: frequency, amount, duration and extent of engagement.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2021
Actual
4/11/2021
Date of last participant enrolment
Anticipated
4/11/2022
Actual
3/07/2022
Date of last data collection
Anticipated
4/01/2024
Actual
Sample size
Target
842
Accrual to date
Final
888
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307723 0
Government body
Name [1] 307723 0
Dementia Centre for Research Collaboration
Country [1] 307723 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 308422 0
None
Name [1] 308422 0
Address [1] 308422 0
Country [1] 308422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307750 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 307750 0
Ethics committee country [1] 307750 0
Australia
Date submitted for ethics approval [1] 307750 0
19/10/2020
Approval date [1] 307750 0
27/11/2020
Ethics approval number [1] 307750 0
HC200837

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108370 0
Dr Louise Mewton
Address 108370 0
The Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney
Level 6, Jane Foss Russell Building (G02)
NSW 2006
Country 108370 0
Australia
Phone 108370 0
+61 2 8627 9048
Fax 108370 0
Email 108370 0
louise.mewton@sydney.edu.au
Contact person for public queries
Name 108371 0
Louise Mewton
Address 108371 0
The Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney
Level 6, Jane Foss Russell Building (G02)
NSW 2006
Country 108371 0
Australia
Phone 108371 0
+61 2 8627 9048
Fax 108371 0
Email 108371 0
louise.mewton@sydney.edu.au
Contact person for scientific queries
Name 108372 0
Louise Mewton
Address 108372 0
The Matilda Centre for Research in Mental Health and Substance Use
The University of Sydney
Level 6, Jane Foss Russell Building (G02)
NSW 2006
Country 108372 0
Australia
Phone 108372 0
+61 2 8627 9048
Fax 108372 0
Email 108372 0
louise.mewton@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRethink My Drink: study protocol for a 12-month randomised controlled trial comparing a brief internet-delivered intervention to an online patient information booklet in reducing risky alcohol consumption among older adults in Australia.2022https://dx.doi.org/10.1111/add.15672
N.B. These documents automatically identified may not have been verified by the study sponsor.