Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001392156
Ethics application status
Approved
Date submitted
16/09/2019
Date registered
11/10/2019
Date last updated
28/04/2021
Date data sharing statement initially provided
11/10/2019
Date results information initially provided
28/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Risk Reduction for Dementia Initiative- North West (RReDI-NoW)
Scientific title
Risk Reduction for Dementia Initiative- North West (RReDI-NoW): a clustered randomized controlled trial of the impact of the Preventing Dementia Massive Online Course on dementia knowledge, attitudes and behavior.
Secondary ID [1] 299298 0
Nil known
Universal Trial Number (UTN)
U1111-1240-3405
Trial acronym
RReDI-NoW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 314425 0
Condition category
Condition code
Public Health 312767 312767 0 0
Health promotion/education
Neurological 312913 312913 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Preventing Dementia Online Course (PDMOOC): Participants will enroll in the PDMOOC delivered online by the Wicking Dementia Research and Education Centre which runs for a period of 4 weeks and takes approximately 8 hours in total (2 hours per week).
The Preventing Dementia (PD) MOOC is a short online course that presents the latest evidence for risk factors for dementia and related behavioural interventions in a highly accessible fashion. The goal of the PD MOOC is to build knowledge and self-efficacy in management of these modifiable dementia risk factors as well as an ability to appraise evidence related to such risk.
The PD MOOC is comprised of 4 modules that are released on a weekly basis, with each module consisting of approximately 2 hours of content and activities. Course material includes pages of text and images, videos, discussion boards and quizzes. Rich learning materials such as explanatory animations are embedded into the course, as well as feedback from Wicking Centre staff on participant posts. The MOOC also involves a substantial social learning component, designed to build efficacy in critiquing media reports on dementia prevention, and highlighting behavioural domains most amenable for change. Completion of end of unit quizzes will provide data on adherence.

Arm 2:Preventing Dementia Online Course (PDMOOC) plus community initiatives: Participants will enrol in the PDMOOC delivered online by the Wicking Dementia Research and Education Centre which runs for a period of 4 weeks and will be invited to participate in community designed community events. This will be coordinated and supported by staff experienced in community engagement. Participants in the MOOC plus community engagement group will be invited via email to engage in community-led initiatives tackling risk factor domains. Following completion of the MOOC, participants will be invited to attend ‘design-thinking’ workshops of up to 3 hours duration to develop initiatives to reduce dementia risk that will engage not only their group but also other members of their community. For example, this may include initiatives to target blood pressure checks, healthy eating, physical activity, social engagement activities and functions, stress reduction and mental wellbeing, diabetes detection and management, sleep apnoea checks, engagement in U3A, TAFE or university study. The codesign process includes consideration of desired outcomes for the community, a synthesis phase, where a range of possible initiatives are considered and developed for the community. The codesign process includes critical review of ideas to enable selection of initiatives relevant to, and generated by the community, based on feasibility, likelihood of success and meeting goals, relative to budget and timelines. After this design process, a limited number of community initiatives will be identified and planning for their implementation in the community will be undertaken. Community events will be delivered via a schedule and for a duration chosen by the participant group in community settings. An attendance list will be recorded for all community engagement activities and as a an output from the codesign process, participants will detemine measures of participation. Participants will identify indicators of participation which are relevant to their community, such as attendance, satisfaction with the engagement activity and willingness to continue with activities.
Intervention code [1] 315571 0
Prevention
Comparator / control treatment
Control arm : Participants will receive static dementia prevention information provided by the researchers online at weekly intervals over four weeks consistent with the timing of delivery of the Preventing Dementia MOOC . The static information will be publicly available dementia risk reduction information in written form covering the key risk factors and the existing evidence base for the risk factor, hosted on the course website. The information will take approximately 30 minutes to read each week for 4 weeks. Log in information will indicate whether the participant has accessed the information.
Control group
Active

Outcomes
Primary outcome [1] 321393 0
Change in Modifiable Dementia Risk Factor profile: a study specific questionnaire. The Dementia risk factor Profile comprises a series of self reported questions about modifiable dementia risks and behavior from which a risk rating is calculated indicating whether their risk is low medium or high for each of 8 factors.
Timepoint [1] 321393 0
6 months post intervention (primary endpoint)
Primary outcome [2] 321568 0
Change in Knowledge of Dementia Risk Reduction measured using a study specific questionnaire designed to measure knowledge of dementia risk factors.
Timepoint [2] 321568 0
6 months post intervention (primary endpoint)
Secondary outcome [1] 374852 0
Knowledge of Dementia, measured using the validated Dementia Knowledge Assessment Survey
Timepoint [1] 374852 0
Baseline, immediately post intervention and 6 months post intervention
Secondary outcome [2] 374853 0
Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction Scale: a validated questionnaire
Timepoint [2] 374853 0
Baseline, immediately post intervention and 6 months post intervention
Secondary outcome [3] 374854 0
Effectiveness of community engagement activities: measured by records of the planning and implementation of activities and indicators such as attendance, satisfaction and intention to continue to undertake activities.
Timepoint [3] 374854 0
Baseline, immediately post intervention and 6 months post intervention
Secondary outcome [4] 375385 0
All Aspects of Health Literacy Scale (AAHLS)- validated scale
Timepoint [4] 375385 0
Baseline, immediately post intervention and 6 months post intervention
Secondary outcome [5] 375386 0
Lubben Social Network Scale - a validated scale
Timepoint [5] 375386 0
Baseline, immediately post intervention and 6 months post intervention
Secondary outcome [6] 375390 0
Hospital Anxiety and Depression Scale (HADS)- a validated scale
Timepoint [6] 375390 0
Baseline, immediately post intervention and 6 months post intervention
Secondary outcome [7] 375391 0
Assessment of Quality of Life (AQoL)-8D- a validated survey
Timepoint [7] 375391 0
Baseline, immediately post intervention and 6 months post intervention

Eligibility
Key inclusion criteria
50 years or older
Resident in the North West of Tasmania
Competent in English Language ( able to understand the online course)
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 50 years
Not resident in North West Tasmania
Not competent in English language ( not able to understand the online course)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by random draw
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation, based on preliminary data, indicated that to detect a 2-point change in the Dementia Risk Profile with a 5% type 1 error rate and 80% power, a total sample of 429 (143 per three-centre cluster) will be required. In order to account for an expected MOOC completion rate of 70% in groups 2 and 3, we require a sample of at least 610 people (approx. 203 per three-centre cluster). To allow for attrition we will recruit at least 650 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2019
Actual
28/10/2019
Date of last participant enrolment
Anticipated
15/10/2020
Actual
18/11/2019
Date of last data collection
Anticipated
15/05/2021
Actual
24/08/2020
Sample size
Target
650
Accrual to date
Final
554
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 28035 0
7320 - Burnie
Recruitment postcode(s) [2] 28036 0
7307 - Port Sorell
Recruitment postcode(s) [3] 28037 0
7310 - Devonport
Recruitment postcode(s) [4] 28038 0
7306 - Sheffield
Recruitment postcode(s) [5] 28039 0
7325 - Wynyard
Recruitment postcode(s) [6] 28040 0
7316 - Penguin
Recruitment postcode(s) [7] 28041 0
7315 - Ulverstone
Recruitment postcode(s) [8] 28042 0
7307 - Latrobe
Recruitment postcode(s) [9] 28043 0
7304 - Deloraine

Funding & Sponsors
Funding source category [1] 303821 0
Government body
Name [1] 303821 0
Medical Research Future Fund: Keeping Australians out of hospital
Country [1] 303821 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Ave, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 303946 0
None
Name [1] 303946 0
Address [1] 303946 0
Country [1] 303946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304335 0
Tasmanian Social Sciences Human Research Ethics Committee
Ethics committee address [1] 304335 0
Office of Research Services
Private Bag 1
Hobart TAS 7001
Ethics committee country [1] 304335 0
Australia
Date submitted for ethics approval [1] 304335 0
02/09/2019
Approval date [1] 304335 0
03/10/2019
Ethics approval number [1] 304335 0
H0018297

Summary
Brief summary
The Risk Reduction for Dementia Initiative – North West (RReDI-NoW) will involve community members in 9 centres across northwest Tasmania to evaluate the Preventing Dementia massive open online course (PD MOOC) with or without additional community led dementia risk reduction initiatives. The effectiveness of the PD MOOC and community initiatives will be measured against providing written information about dementia risk reduction in a randomised controlled trial. The aims of the study are:
• To examine the impact of the PD MOOC on dementia risk reduction knowledge, attitudes and behaviour, and risk states.
• To examine whether engaging communities in dementia risk reduction initiatives has additional benefits above education through the MOOC alone.
• To examine the sustainability of any improvements in dementia risk reduction knowledge, attitudes and behaviour, and risk states.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96586 0
Dr Kathleen Doherty
Address 96586 0
Wicking Dementia Research and Education Centre
College of Health and Medicine
17 Liverpool St Hobart 7001
Tasmania
Country 96586 0
Australia
Phone 96586 0
+61 03 6226 4752
Fax 96586 0
Email 96586 0
[email protected]
Contact person for public queries
Name 96587 0
Dr Deirdre McLaughlin
Address 96587 0
Wicking Dementia Research and Education Centre
College of Health and Medicine
17 Liverpool St Hobart 7001
Tasmania
Country 96587 0
Australia
Phone 96587 0
+61 03 6430 1686
Fax 96587 0
Email 96587 0
[email protected]
Contact person for scientific queries
Name 96588 0
Dr Kathleen Doherty
Address 96588 0
Wicking Dementia Research and Education Centre
College of Health and Medicine
17 Liverpool St Hobart 7001
Tasmania
Country 96588 0
Australia
Phone 96588 0
+61 03 6226 4752
Fax 96588 0
Email 96588 0
[email protected]

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


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
EmbaseRandomised controlled trials for the prevention of cognitive decline or dementia: A systematic review.2022https://dx.doi.org/10.1016/j.arr.2022.101777
N.B. These documents automatically identified may not have been verified by the study sponsor.