Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000977875
Ethics application status
Approved
Date submitted
20/05/2021
Date registered
26/07/2021
Date last updated
11/01/2024
Date data sharing statement initially provided
26/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
MyCOACH (COnnected Advice for Cognitive Health) -
Evaluation of an e-learning and active lifestyle program for cognitive decline and risk of dementia in adults with mild cognitive impairment or subjective cognitive decline.
Scientific title
Evaluation of an e-learning and active lifestyle program against active control, for cognitive decline and risk of dementia in adults with mild cognitive impairment or subjective cognitive decline.
Secondary ID [1] 303616 0
Nil known
Universal Trial Number (UTN)
U1111-1265-2696
Trial acronym
MyCOACH (COnnected Advice for Cognitive Health)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment (MCI) 320991 0
Subjective Cognitive Decline (SCD) 320992 0
Risk of dementia 320994 0
Cognitive decline 320995 0
Risk of Alzheimer's disease 322974 0
Condition category
Condition code
Neurological 318799 318799 0 0
Alzheimer's disease
Neurological 318800 318800 0 0
Dementias
Public Health 318801 318801 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project has two arms, the ‘MyCoach online intervention’ and an active control. The sample will be adults aged 65 years and older, with subjective cognitive decline or mild cognitive impairment. Participants allocated to the MyCoach intervention group will be required to complete an online dementia risk reduction education program and they will be offered a 3-month subscription to computerised brain training, as well as consultations with a dietician and an exercise physiologist.

E-learning: The e-learning will consist of 6 online chapters, approximately 30-40 minutes each (topics include 1. General Information, 2. Physical Activities, 3. Diet, 4. Memory Strategies, 5. Social and Cognitive Engagement and 6. Stress). Each chapter will contain background information, interactive activities, reflections and goal setting to assist with behaviour change. Participants will receive the above chapters on weeks 1,2,4,6,8 and 10. Each chapter will be accessible until week 12.

Consultations: The dietician and exercise physiologist will conduct telehealth consults with each participant to create individualised diet and exercise goals. The consultants will base recommendations on the MIND diet and Australian physical activity guidelines. They will adapt advice around comorbidities, resources and preferences, thus enabling safe and effective implementation in this population. The first physical activity consultation (45 mins) and the first diet consultation (45 mins) will take place after the corresponding chapters (physical activity + diet) are made available to the participant. Each participant will then receive a follow-up consultation for physical activity (30 mins) and diet (30 mins) 4 weeks after the first consultation. The aim of this is to review and support participants progress in their goals.

Computerised brain training (Posit Science – BrainHQ): Each participant will be provided with a 12-week subscription to BrainHQ during week 1 of the intervention. Each participant will be asked to complete two executive function tasks (Double Decision & Divided Attention) and two memory tasks (Memory Grid & Syllable Stacks) per week, totaling 2 hours.

Booster session: The booster session will take the form of one 30–45-minute phone call with a study researcher 3-months after the intervention period. The booster session will be guided by a standardised template drawing on motivational interviewing principles to discuss goal progression and support behaviour change. It will also include a recap on session materials.

Adherence to the e-learning component of the intervention will be monitored through website statistics (e.g., time spent on chapter and the number completed), we will also record if participants choose not to attend the consultations or access the brain training. To encourage adherence, we will send participants a reminder email if they have not completed a chapter (up to 3 reminders). However, unlocking the next chapter will not be dependent on completion on the previous.

As a form of process evaluation, within the chapters there will be questions relating to participant’s familiarity of the topic, willingness to change behaviour and perceptions of health. Through the chapters and booster session, we will also collect information on goals set by participants and general feedback.
Intervention code [1] 319903 0
Prevention
Intervention code [2] 319904 0
Lifestyle
Intervention code [3] 319905 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will receive a bulletin email at the same rate as the intervention chapter release (i.e. week 1, 2, 4, 6, 8 and 10). The information contained in the email bulletin will be general and correspond to topics in the intervention (namely, 1. General Information, 2. Physical Activities, 3. Diet, 4. Memory Strategies, 5. Social and Cognitive Engagement and 6. Stress). The information will not include specific strategies or interactive stimulus for behaviour change, risk reduction and goal setting. The control group will not receive the health consults, brain training or booster sessions.

At the end of the study, after the 1 year follow-up data collection is complete, the control group will be given access to the full MyCoach online course (not including professional consultation or BrainHQ subscription).
Control group
Active

Outcomes
Primary outcome [1] 326743 0
The Primary Outcome measure is the level of exposure to dementia risk factors as measured by the ANU-Alzheimer's Disease Risk Index (ANU-ADRI). The ANU-ADRI is a validated self-report scale assessing 15 individual risk and protective factors for Alzhiemer's disease and dementia.
Timepoint [1] 326743 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64 - primary end point).
Secondary outcome [1] 392543 0
The Secondary Outcome measure is a composite score of cognition. This will be comprised of a number of validated cognitive tests, namely:
1. Trails B oral (measuring cognitive flexibility and executive function)
2. Hopkins Verbal Learning Test–Revised (HVLT-R; measuring immediate verbal memory and learning)
3. Hopkins Verbal Learning Test–Revised delayed (HVLT-R delayed; measuring delayed verbal memory)
4. Symbol Digit Modalities Test - Oral (measuring attention and processing speed)
5. Victoria Stroop Test - colour dots (measuring attention and processing speed)
6. Victoria Stroop Test - colour words (measuring executive function)
Timepoint [1] 392543 0
Measured at baseline (week 0), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [2] 392546 0
Quality of life, as measured by Short-Form Health Survey (SF-36)
Timepoint [2] 392546 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [3] 392548 0
Motivation, as measured by Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction Scale (MCLHB-DRR)
Timepoint [3] 392548 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [4] 392549 0
Self-perceptions of ageing as measured by Brief Ageing Perceptions Questionnaire (B-APQ)
Timepoint [4] 392549 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [5] 392550 0
Self efficacy as measured by General Self-Efficacy Scale (GSES)
Timepoint [5] 392550 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [6] 392551 0
MIND diet score derived from an adapted Australian Recommended Food Score (ARFS) questionnaire
Timepoint [6] 392551 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [7] 393409 0
Functional ability measured by Instrumental Activities of Daily Living - Extended Scale
Timepoint [7] 393409 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [8] 393410 0
Morale and attitudes towards ageing measured by Lawton's Morale Scale.
Timepoint [8] 393410 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).
Secondary outcome [9] 397205 0
Qualitative information on goal setting measured by a study-specific questionnaire
Timepoint [9] 397205 0
Measured during the MyCoach intervention, within the e-learning course (chapters 1-6)
Secondary outcome [10] 398747 0
Qualitative information on lifestyle measured by a study-specific questionnaire
Timepoint [10] 398747 0
Measured during the MyCoach intervention, within the e-learning course (chapters 1-6)
Secondary outcome [11] 411346 0
Dementia Knowledge as measured by Dementia Literacy Questionnaire (Anstey & Low), adapted for this trial and new knowledge about dementia risk factors.
Timepoint [11] 411346 0
Measured at baseline (week 0), immediately after the intervention (week 13), 6-months after the intervention (week 38) and 1 year after the intervention (week 64).

Eligibility
Key inclusion criteria
• Changes in memory or thinking (subjective cognitive decline (SCD)) or a diagnosis of mild cognitive impairment (MCI).
• Clinically significant subjective memory complaints (MAC-Q score: >=25)
• Absence of severe cognitive impairment (TICS score: >21)
• 65 years of age or older
• Ability to read, write and communicate in English to a comfortable level
• Willingness to complete an online course and interviews over telephone/video
• No current diagnosed psychiatric or neurological disorders (other than MCI)
• Not currently participating in a similar healthy ageing intervention
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Diagnosis of dementia

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)
Participants who meet all inclusion and no exclusion criteria will be invited for the baseline evaluation over the telephone. Following the baseline assessment, participants will be randomised into one of the two groups through a pre-determined allocation sequence, concealed by a central randomisation computer system – REDCap. Participants will be advised of their allocation by a member of the research team who is not involved in testing of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by a study statistician who is also not involved in the testing of participants. Block randomisation will be generated using STATA. The randomisation will allocate participants to one of two treatment arms with 1:1 allocation. Allocation will be based on 4 strata (sex and 2 age groups (65-74 & 75+)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
The total sample size required for this project is 326 participants (163 per group). The sample size calculation was based on the assumption that the ANU-ADRI risk score will reduce by 0.5SD at the end of the final follow-up (64 weeks) for the intervention group. We also assumed the correlation coefficients between the outcome measures in 3 times points would be 0.7 and attrition would be 30% in 64 weeks,

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
8/11/2021
Date of last participant enrolment
Anticipated
29/05/2023
Actual
26/05/2023
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
326
Accrual to date
Final
326
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308035 0
Government body
Name [1] 308035 0
National Health & Medical Research Council (NHMRC)
Country [1] 308035 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
School of Psychology
University of New South Wales
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 308759 0
Other
Name [1] 308759 0
Neuroscience Research Australia (NeuRA)
Address [1] 308759 0
Margarete Ainsworth Building
139 Barker Street
Randwick, NSW 2031
Country [1] 308759 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308030 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 308030 0
Ethics committee country [1] 308030 0
Australia
Date submitted for ethics approval [1] 308030 0
17/02/2021
Approval date [1] 308030 0
19/02/2021
Ethics approval number [1] 308030 0
210012

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

Contacts
Principal investigator
Name 109274 0
Prof Kaarin Anstey
Address 109274 0
NeuRA
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Australia
Country 109274 0
Australia
Phone 109274 0
+61 2 9399 1019
Fax 109274 0
Email 109274 0
[email protected]
Contact person for public queries
Name 109275 0
Kaarin Anstey
Address 109275 0
NeuRA
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Australia
Country 109275 0
Australia
Phone 109275 0
+61 2 9399 1019
Fax 109275 0
Email 109275 0
[email protected]
Contact person for scientific queries
Name 109276 0
Kaarin Anstey
Address 109276 0
NeuRA
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Australia
Country 109276 0
Australia
Phone 109276 0
+61 2 93991019
Fax 109276 0
Email 109276 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


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
EmbaseMyCOACH (COnnected Advice for Cognitive Health): a digitally delivered multidomain intervention for cognitive decline and risk of dementia in adults with mild cognitive impairment or subjective cognitive decline-study protocol for a randomised controlled trial.2023https://dx.doi.org/10.1136/bmjopen-2023-075015
N.B. These documents automatically identified may not have been verified by the study sponsor.