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Trial registered on ANZCTR


Registration number
ACTRN12618001136291
Ethics application status
Approved
Date submitted
2/07/2018
Date registered
11/07/2018
Date last updated
2/11/2018
Date data sharing statement initially provided
2/11/2018
Date results information initially provided
2/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of an online intervention program to reduce dementia-related stigma in the general public aged 40 and older
Scientific title
Dementia Stigma Reduction (DESeRvE): A randomised controlled trial to determine the effect of an online intervention on dementia-related stigma in the general public aged 40 and older.
Secondary ID [1] 295178 0
None
Universal Trial Number (UTN)
Trial acronym
DESeRvE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia-related stigma 308476 0
Lack of dementia knowledge 308477 0
Condition category
Condition code
Neurological 307455 307455 0 0
Dementias
Neurological 307456 307456 0 0
Alzheimer's disease
Public Health 307457 307457 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This RCT compares different approaches to reduce dementia-related stigma: Education (ED) that is designed to provide written information on dementia; Contact (CT) that is designed to offer indirect virtual contact with people with dementia and/or carers; ED+CT that receive both ED and CT interventions; and an Active Control condition receiving information on general health.

For the ED group, an adaptation of the dementia literacy module from the Body Brain Life (BBL; Trial ID:ACTRN12612000147886), the first online intervention program designed to reduce the risk of developing dementia, will be delivered online. The dementia literacy module was developed and improved with consumers direct feedback and it provides in-depth information about dementia in terms of definition, symptoms, pathology, and treatments. The BBL is written in lay persons language and is proven to improve dementia literacy in an RCT. Information on dementia-related stigma and its impacts have been added to this module for the current protocol and it will take approximately 20 minutes to complete the module. However, there is no time limit and participants would be able to complete the module within a week of starting it. Sharing accurate information is expected to offer information to help people better understand dementia and dispel misconceptions about the disease. Web analytics will be used to assess adherence to the intervention.

Participants in the CT group will watch video clips reflecting what it is like to live with dementia and what it is like to care for someone with dementia. These video clips were created featuring people with dementia and carers answering frequently asked questions drawn from a focus group study conducted with 31 mid and older aged Australians. These questions include questions about dementia and about living with dementia (e.g. what is dementia? how can a family member better manage the life of a person with dementia?). To enhance the effects of the contact component, the DESeRvE program is designed so that the participants can choose questions from a pool of questions about what they would like to learn from people with dementia or carers. The program will then play relevant pre-recorded video clips in response to questions. This method will be used to make participants feel as if they are having a virtual conversation with a real person with dementia or carers instead of receiving a one-way dialogue. It is expected to be at least as effective as commonly used video-based contact approach, if not more effective. The participants will be able to ask as many questions as they wish within 20 minutes (including time to play video clips). As for the ED group, adherence will be assessed using web analytics and the CT intervention will be available for a week from the start of the intervention.

This trial will be conducted to evaluate the short-term efficacy of an online intervention program utilising different approaches (ED, CT and ED+CT) compared with the Active Control. There will be 500 participants (125 in ED, 125 in CT, 125 in ED+CT and 125 in the Active Control group) followed for 12 weeks from baseline. There will be 2 follow up assessments (immediately after the completion of the intervention and at 12 weeks after commencement of the intervention).
Intervention code [1] 301622 0
Behaviour
Comparator / control treatment
Participants allocated to the Active Control group will receive written information related to general health, drawn from the Australian Institute of Health and Wellfare website (https://www.aihw.gov.au/reports-statistics/health-conditions-disability-deaths, https://www.aihw.gov.au/risk-factors).
Control group
Active

Outcomes
Primary outcome [1] 306428 0
The primary outcome is participants' level of stigma about people with dementia. It will be assessed with an adapted version of the Attribution Questionnaire (AQ; Corrigan, Markowitz, Watson, Rowan & Kubiak, 2003), assessing the cognitive, emotional, and behavioural aspects of public stigma in mental illness. We will substitute the term "mental illness" with the term "dementia" and specify stages and types of dementia (e.g. People with dementia should be put into a nursing home, even if they are at an early stage of dementia). This scale is not designed specifically for this study.
Timepoint [1] 306428 0
Public dementia-related stigma scale will be assessed at baseline, immediately after the intervention (primary endpoint) and 12 weeks after commencement of the intervention.
Secondary outcome [1] 348523 0
Dementia knowledge will be assessed with Dementia Knowledge Assessment Scale (DKAS) version 2.
Timepoint [1] 348523 0
Dementia Knowledge Assessment Scale will be assessed at baseline, immediately after the intervention and 12 weeks after commencement of the intervention.

Eligibility
Key inclusion criteria
Adults who are 40 years or older; proficient in English and have internet access.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of Alzheimer's disease or other dementia; visual and auditory deficits (to be able to watch video clips)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet all inclusion and no exclusion criteria will be invited to take part in this RCT online. Participants will be randomised into one of the four groups using a randomisation function on a survey platform (Qualtrics). Randomisation will be stratified by gender, age and state.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial will use computer-generated randomisation procedure, stratified by gender, age and state.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations were estimated using G*Power (version 3.1.9.2). To detect a medium size effect in one control and three experimental conditions with a 5% risk of type I error and 95% power, a total sample size of 280 persons is required. We will collect 500 participants at baseline with 40% of dropout rate in mind.

Descriptive statistics will be calculated for the outcome stratified by gender, age and state. A one-way repeated measures analysis of variance will be used to determine the difference between treatment groups over time. In the event of highly correlated responses over time, a longitudinal model will also be fitted to the data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299885 0
Charities/Societies/Foundations
Name [1] 299885 0
Dementia Australia Research Foundation
Address [1] 299885 0
Level 1, AMA House
42 Macquarie Street
Barton ACT 2600
Country [1] 299885 0
Australia
Primary sponsor type
Individual
Name
Dr Sarang Kim
Address
Centre for Research on Ageing, Health and Wellbeing
Building 54, Mills Road
The Australian National University
Acton 2601
ACT
Country
Australia
Secondary sponsor category [1] 299240 0
None
Name [1] 299240 0
None
Address [1] 299240 0
None
Country [1] 299240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300754 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 300754 0
Research Integrity & Compliance
Research Services Division
Level 2, Birch Building 36
Science Road
The Australian National University
Acton ACT 2601
Ethics committee country [1] 300754 0
Australia
Date submitted for ethics approval [1] 300754 0
19/06/2018
Approval date [1] 300754 0
20/08/2018
Ethics approval number [1] 300754 0

Summary
Brief summary
This project evaluates the short-term efficacy of the Dementia Risk Reduction (DESeRvE) program involving 3 different approaches (Education (ED), Contact (CT), Education plus contact (ED+CT)), in stigma reduction for dementia using a Randomised Controlled Trial (RCT). There will also be an Active Control group which receive information on general health. It is hypothesised that the level of dementia-related stigma and dementia knowledge will be reduced and enhanced respectively for those in the intervention groups more than those in the Active Control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65554 0
Dr Sarang Kim
Address 65554 0
Centre for Research on Ageing, Health and Wellbeing
Building 54, Mills Road
The Australian National University
Acton 2601
ACT
Country 65554 0
Australia
Phone 65554 0
+61261250713
Fax 65554 0
Email 65554 0
sarang.kim@anu.edu.au
Contact person for public queries
Name 65555 0
Dr Sarang Kim
Address 65555 0
Centre for Research on Ageing, Health and Wellbeing
Building 54, Mills Road
The Australian National University
Acton 2601
ACT
Country 65555 0
Australia
Phone 65555 0
+61261250713
Fax 65555 0
Email 65555 0
sarang.kim@anu.edu.au
Contact person for scientific queries
Name 65556 0
Dr Sarang Kim
Address 65556 0
Centre for Research on Ageing, Health and Wellbeing
Building 54, Mills Road
The Australian National University
Acton 2601
ACT
Country 65556 0
Australia
Phone 65556 0
+61261250713
Fax 65556 0
Email 65556 0
sarang.kim@anu.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
Individual participant data will not be available as indicated in the information sheet given to participants.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary