Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000454471
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
14/05/2025
Date last updated
14/05/2025
Date data sharing statement initially provided
14/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
CogCoach-Health Randomised Controlled Trial - a lifestyle program targeting brain health in people with cognitive concerns
Scientific title
CogCoach-Health Randomised Controlled Trial - evaluation of an e-health intervention targeting dementia risk factors in older adults with subjective cognitive decline or Mild Cognitive Impairment
Secondary ID [1] 313661 0
Nil known
Universal Trial Number (UTN)
U1111-1317-6133
Trial acronym
CogCoach-Health RCT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Subjective Cognitive Decline (SCD) 336269 0
Mild Cognitive Impairment (MCI) 336270 0
Condition category
Condition code
Neurological 332814 332814 0 0
Alzheimer's disease
Public Health 332815 332815 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CogCoach-Health online intervention includes the following:

e-Learning:
Completion of a 12-week online dementia risk reduction education program. The e-Learning component will consist of six online modules (Chapters), approximately 30-40 minutes in length each, that participants open, learn and complete individually. The modules topics are: 1. Introduction to the e-Learning course and general information about healthy brain ageing; 2. Looking After Your Memory; 3. Physical Activity; 4. Staying Cognitively and Socially Active; 5. Healthy Diet; and 6. Stress Reduction. Each module will contain background information on the specific topic, interactive activities, reflections and goal setting to assist with behaviour change. The intervention participants will receive the above Chapters on Weeks 1, 2, 4, 6, 8 and 10.

Telehealth Consultations:
One session on Cognitive Engagement will be conducted by a research assistant who has at least 4 years training in psychology. The session will be conducted individually via videoconferencing and, where that is not possible, by phone and will last up to 1 hour. It will occur in Week 1 or as soon as can be arranged after randomisation. It will involve discussion and planning of a ‘Cognitive diary’ and goal setting related to engaging in cognitively stimulating activities. Advice will also be given for undertaking cognitive training using the BrainHQ program for which they will be given a 3 month subscription. Access to BrainHQ will be given around Week 1 of the intervention. Each participant is encouraged to complete training on two executive function and two memory tasks, for up to 2 hours per week. These online, game-like tasks are mental exercises that are tailored to the level of ability of the participant and gradually increase in difficulty to increase performance.

Two consultation sessions on physical activity will be conducted by an exercise physiologist (EP). The sessions will be conducted individually via videoconferencing and, where that is not possible, by phone and will last up to 1 hour each. Sessions will occur approximately in Weeks 5 and 7. The first session will involve the development of a personalised exercise plan for the participant. Recommendations will be based on the Australian guidelines for physical activity. In the second consultation the exercise physiologist will review participants’ exercise plans and support them in achieving their goals. If in line with the exercise goals, the EP will also introduce the StandingTall app to support maintenance of physical activity, and advise on how to use this app. The StandingTall app is a digital exercise program delivered via an app on a tablet device. StandingTall offers adaptive exercises guided by visual demonstrations, audio cues and educational content adjusts exercise difficulty based on participant feedback. Participants are able to use their own tablet device, or one supplied by the study.

Two consultation sessions on diet will be conducted by a dietician. The session will be conducted individually via videoconferencing and, where that is not possible, by phone. Sessions will last up to 1 hour each and will occur approximately in Weeks 9 and 11. The first session will involve the development of an individualised diet plan and goal setting. Recommendations will be based on the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet. The MIND diet emphasises unprocessed fruit, vegetables, whole grains, nuts, olive oil, fish, legumes and low consumption of red meat. Adaptations will be made to apply the diet in a culturally sensitive manner. The second consultation involves review of participants’ diet and supporting them in achieving their goals.

Physical activity and diet recommendations will be adapted around comorbidities, resources and preferences, thus enabling safe and effective implementation.

Telehealth booster sessions:
Telehealth booster sessions will be conducted at approximately 4 months and again approximately at 9 months after the completion of the eLearning. These sessions will be conducted by videoconference if possible, and alternatively by phone, and take approximately 40 minutes each. The booster sessions will be guided by a standardised template drawing on motivational interviewing principles to discuss goal progression and support behaviour change. They will also include a recap on session materials.

Adherence:
Adherence to the e-Learning components will be monitored through website statistics (e.g., time spent on each chapter, number of chapters completed, number of chapter activities completed). We will also record if participants choose not to attend the consultations or access the cognitive brain training. To encourage adherence, we will send participants reminder emails if they have not completed a chapter. However, unlocking the next chapter will not be dependent on completion of the previous one.

Process evaluation:
As a form of process evaluation within the chapters there will be questions relating to participants’ familiarity of the topic, willingness to change behaviour and perceptions of health. Through the chapters and booster sessions, we will also collect information on goals set by participants and general feedback.
Intervention code [1] 330286 0
Prevention
Intervention code [2] 330287 0
Lifestyle
Intervention code [3] 330288 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will receive fortnightly email bulletins at the same schedule as the intervention (i.e., Week 1, 2, 4, 6, 8 and 10). The information contained in the email bulletins will be general and correspond to topics in the intervention, namely, 1. General information about healthy brain ageing; 2. Looking After Your Memory; 3. Physical Activity; 4. Staying Cognitively and Socially Active; 5. Healthy Diet; and 6. Stress Reduction. The information will not include strategies or interactive stimulus for behaviour change, risk reduction and goal setting.
At the end of the study, after the final follow-up data collection is complete, the control group will be given access to the full CogCoach-Health online course (not including cognitive engagement, exercise physiology and diet consultations, access to computerised brain training, nor booster sessions).
Control group
Active

Outcomes
Primary outcome [1] 340346 0
Level of exposure to dementia risk factors will be assessed by the validated Australian National University- Alzheimer's Disease Risk Index (ANU-ADRI).
Timepoint [1] 340346 0
Baseline, Immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention (primary endpoint)
Secondary outcome [1] 444586 0
Cognitive function
Timepoint [1] 444586 0
Baseline, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [2] 444587 0
Level of physical activity
Timepoint [2] 444587 0
Baseline, immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [3] 444588 0
Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet
Timepoint [3] 444588 0
Baseline, immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [4] 444589 0
Cognitive engagement
Timepoint [4] 444589 0
Baseline, immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [5] 444590 0
Health-related quality of life
Timepoint [5] 444590 0
Baseline, immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [6] 445626 0
Weekly step count
Timepoint [6] 445626 0
Baseline, immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [7] 445628 0
Quality of Life
Timepoint [7] 445628 0
Baseline, immediate post completion of the 12-week intervention, 6 months post completion of the 12-week intervention and 12 months post completion of the 12-week intervention
Secondary outcome [8] 446491 0
Dementia literacy
Timepoint [8] 446491 0
Baseline, immediate post completion of 12-week intervention, 6 months post completion of intervention, 12 months post completion of intervention
Secondary outcome [9] 446492 0
Health literacy
Timepoint [9] 446492 0
Baseline, immediate post completion of 12-week intervention, 6 months post completion of intervention, 12 months post completion of intervention

Eligibility
Key inclusion criteria
- Subjective cognitive decline (defined as ECog-12 score < 1.54) or a diagnosis of mild cognitive impairment (MCI)
- 65 years of age or older
- Ability to read, write and communicate in English to a comfortable level
- Willingness to complete an online course, lifestyle factor questionnaires and interviews over phone/video call
- Willingness to nominate a friend, family or carer who is willing to provide information about the participant's memory and thinking and their everyday behaviour at the beginning and the end of the study.
- Presence of at least 1 of the following risk factors measured with items from the CogDrisk Tool (Insufficient physical activity, poor diet, low cognitive engagement).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Moderate or severe cognitive impairment (age and education adjusted Modified Telephone Interview for Cognitive Status (TICS-M) <= 21 out of 39 points)
- Currently participating in a similar healthy ageing or brain health intervention
- Medical condition or treatments that would impact participation in the trial (to be discussed during screening)

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 assessment conducted via videoconferencing, and where that is not possible, by phone. 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 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 age (65-69, 70-74, 75-79,80-84 and 85+) and sex (male, female, other term).
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
Sample size calculation:
Previous studies suggested that baseline mean and standard deviation of ANU-ADRI is -0.82 (5.67). For the primary hypothesis we hypothesized that the CogCoach-Health intervention will lead to a reduction of approximately 3 points on the ANU-ADRI scale, which would require a sample size of 166 participants with 80% power and 5% level of significance. For the secondary hypotheses we estimated that a minimum sample size of 634 is required to detect the target effect for cognition (a difference of 0.25 SD in the mNTB composite score between the intervention and active control group) at the end of the final 12-month follow-up with type 1 error of 5% (a = 0.05) and 80% power (ß = 0.20), using STATA. Therefore, a sample size of 634 is sufficient to test both primary and secondary hypotheses.

Analysis:
Demographic and baseline variables of participants will be summarised and presented by each arm using frequencies and percentages for categorical variables, mean and standard deviation for continuous variables, or median and quartiles (25th and 75th percentile) for non-symmetrical continuous variables.
In addition, the primary outcome (ANU-ADRI score) in the intervention and control group between baseline and 12-month follow-up will be compared using a difference-in-difference approach (i.e., using a linear regression with interaction between intervention/control group and the time points).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
634
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318126 0
Government body
Name [1] 318126 0
Department of Health and Aged Care, Dementia Ageing and Aged Care Mission, Medical Research Future Fund
Country [1] 318126 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 320509 0
None
Name [1] 320509 0
Address [1] 320509 0
Country [1] 320509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316774 0
The University of New South Wales Research Ethics Committee A
Ethics committee address [1] 316774 0
Ethics committee country [1] 316774 0
Australia
Date submitted for ethics approval [1] 316774 0
05/12/2024
Approval date [1] 316774 0
07/02/2025
Ethics approval number [1] 316774 0
iRECS6997

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

Contacts
Principal investigator
Name 138970 0
Prof Kaarin J Anstey
Address 138970 0
Rm 1203 Matthews Building, University of New South Wales Sydney, Kensingtion, NSW
Country 138970 0
Australia
Phone 138970 0
+61 2 9399 1019
Fax 138970 0
Email 138970 0
[email protected]
Contact person for public queries
Name 138971 0
Kaarin J Anstey
Address 138971 0
Rm 1203 Matthews Building, University of New South Wales Sydney, Kensingtion, NSW
Country 138971 0
Australia
Phone 138971 0
+61 2 9399 1019
Fax 138971 0
Email 138971 0
[email protected]
Contact person for scientific queries
Name 138972 0
Kaarin J Anstey
Address 138972 0
NeuRA, Margarete Ainsworth Building, 139 Barker Street, Randwick NSW 2031
Country 138972 0
Australia
Phone 138972 0
+61 2 9399 1019
Fax 138972 0
Email 138972 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
• Analyses that pool data from multiple similar trials

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.