Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001242112
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
9/09/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
9/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a providing an online personal dementia risk profile to improve dementia risk knowledge - Dementia risk profiling tool pilot trial
Scientific title
Feasibility of a providing an online personal dementia risk profile to improve dementia risk knowledge - Dementia risk profiling tool pilot trial
Secondary ID [1] 299115 0
DRPTPilot2019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 313927 0
Dementia Risk 313928 0
Condition category
Condition code
Neurological 312335 312335 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to give consent for the researchers to access your Healthy Brain Ageing clinic assessment records. From this researchers will populate a personalised dementia risk profile. Participants will receive an email with their personal dementia risk profile (pdf format) within two weeks. The personal risk profile is based on their HBA clinic assessment. A short online questionnaire about knowledge of dementia risk, motivation to engage in dementia risk reduction, and distress will be asked pre and post being provided the dementia risk profile.

Participants will also be given the option to participate in a telephone interview to debrief and provide us with additional feedback, which will be audio recorded.
Intervention code [1] 315214 0
Early detection / Screening
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320963 0
Dementia risk knowledge

To asses the overall dementia risk knowledge two survey questions will be asked 1) the perceived susceptibility and 2) the knowledge of risk reduction.

- To assess for perceived susceptibility, participants will be asked “How likely is it do you think that you will get Alzheimer’s disease in your lifetime?” The answer can range from 0 to 100, where 0=certain not to happen and 100=certain to happen.
At follow up, to examine accuracy of perceived risk, the participant’s perceived risk will be subtracted from their actual risk estimate. Positive values indicate underestimation of risk while negative values indicate overestimation of risk. Scores will be then recorded into a dichotomous variable (less than or equal to +/-10% vs greater than or to +/-10%), indicating whether perceived risk was similar to the predicted risk.
- To assess knowledge of risk reduction, we have included the knowledge of dementia risk and protective factors questionnaire and added extra risk and protective factors identified in the Lancet commission for dementia prevention. Questions from an Australian community survey will be used to assess top 5 things they can do to reduce risk, and confidence in risk reduction.
Timepoint [1] 320963 0
three weeks post-baseline completion
Secondary outcome [1] 373526 0
Motivation to Change Lifestyle and Health Behaviour for Dementia Risk Reduction
Timepoint [1] 373526 0
three weeks post-baseline completion
Secondary outcome [2] 373527 0
Psychological effects
- The K10 is a commonly used screening scale for non-specific psychological distress validated for use in Australia. The K10 has also been demonstrated as having moderate sensitivity to symptoms change in an Australian sample. Scores on the K10 range from 10 to 50, and a score of 30 or more indicates severe level of distress.
- The Dementia Worry Scale is used to assess dementia worry. It has strong internal consistency and test-retest reliability. It consists of 12 items with scores ranging from 15 to 60.
Timepoint [2] 373527 0
three weeks post-baseline completion
Secondary outcome [3] 373529 0
User evaluation
- We adapted a five-point scale (from 1= not at all to 5= completely) previously used to assess user experience of a dementia information website, participants are asked whether the information provided was engaging, easy to understand, how helpful they found the risk profile, and how much they felt they learned (from 1=nothing at all to 5=a great deal). Additionally, participants are asked: Do you feel you need more information about your dementia risk profile? [yes / no] and are given the option to discuss their experience of using the risk profile with a researcher in a telephone interview.
Timepoint [3] 373529 0
three weeks post-baseline completion

Eligibility
Key inclusion criteria
Patients at the Healthy Brain Aging (HBA) clinic with mild cognitive impairment (MCI) or subjective cognitive decline (SCD) who have received neuropsychological test feedback.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Those diagnosed at the HBA clinic with dementia or pre-existing severe cognitive impairment due to neurological conditions, psychosis, intellectual disability, substance misuse, stroke, or acquired brain injury.
- To minimise burden on HBA clinic patients, those who have already been approached to participate in 3 other studies and/or are participating in an intervention or longitudinal study as part of their involvement with the HBA clinic.
- Does not have reliable access to the Internet.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2019
Actual
Date of last participant enrolment
Anticipated
10/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27448 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 303481 0
Charities/Societies/Foundations
Name [1] 303481 0
Dementia Australia Research Foundation
Country [1] 303481 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Central Clinical School and Brain and Mind Centre, Faculty of Medicine and Health, University of Sydney
Address: Level 5, Professor Marie Bashir Centre, 67-73 Missenden Road, Camperdown, NSW 2050, Australia.
Country
Australia
Secondary sponsor category [1] 303541 0
None
Name [1] 303541 0
Address [1] 303541 0
Country [1] 303541 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304010 0
The University of Sydney Research Integrity and Ethics
Ethics committee address [1] 304010 0
Level 3, Administration Building (F23)
The University of Sydney NSW 2006
Ethics committee country [1] 304010 0
Australia
Date submitted for ethics approval [1] 304010 0
15/07/2019
Approval date [1] 304010 0
26/09/2019
Ethics approval number [1] 304010 0
2019/669

Summary
Brief summary
Our team has conducted focus groups with at-risk older adults to co-design an online dementia risk profiling tool. This pilot study aims to examine the feasibility of providing a personal dementia risk profile to help-seeking adults at-risk of developing dementia. The study will provide preliminary evidence on the impact of the personal risk profiles on improving Alzheimer’s disease risk knowledge (personal susceptibility and risk factors). The study will also explore the impact of improving dementia risk knowledge on motivation to engage in behaviour change and psychological effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95550 0
Dr Isabella Choi
Address 95550 0
Level 5, Professor Marie Bashir Centre,
67-73 Missenden Road,
Camperdown, NSW 2050
Country 95550 0
Australia
Phone 95550 0
+61 2 8627 7240
Fax 95550 0
Email 95550 0
[email protected]
Contact person for public queries
Name 95551 0
Dr Isabella Choi
Address 95551 0
Level 5, Professor Marie Bashir Centre,
67-73 Missenden Road,
Camperdown, NSW 2050
Country 95551 0
Australia
Phone 95551 0
+61 2 8627 7240
Fax 95551 0
Email 95551 0
[email protected]
Contact person for scientific queries
Name 95552 0
Dr Isabella Choi
Address 95552 0
Level 5, Professor Marie Bashir Centre,
67-73 Missenden Road,
Camperdown, NSW 2050
Country 95552 0
Australia
Phone 95552 0
+61 2 8627 7240
Fax 95552 0
Email 95552 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
to protect individual privacy


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
EmbaseCommunicating Personal Risk Profiles of Alzheimer's Disease to Older Adults: A Pilot Trial.2022https://dx.doi.org/10.14283/jpad.2021.34
N.B. These documents automatically identified may not have been verified by the study sponsor.