Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001269628
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
6/12/2023
Date last updated
6/12/2023
Date data sharing statement initially provided
6/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Cluster Randomised Trial assessing the impact of the Ageing Well Tool on Risks for Poor Wellbeing and Dementia in Older Adults in Primary Care Settings
Scientific title
Cluster Randomised Trial assessing the impact of the Ageing Well Tool on Risks for Poor Wellbeing and Dementia in Older Adults in Primary Care Settings
Secondary ID [1] 310657 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 331553 0
Poor wellbeing 331554 0
Condition category
Condition code
Ear 328283 328283 0 0
Deafness
Cardiovascular 328284 328284 0 0
Hypertension
Diet and Nutrition 328286 328286 0 0
Obesity
Metabolic and Endocrine 328287 328287 0 0
Diabetes
Mental Health 328288 328288 0 0
Depression
Mental Health 328289 328289 0 0
Anxiety
Mental Health 328290 328290 0 0
Addiction
Public Health 328291 328291 0 0
Health promotion/education
Neurological 328862 328862 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Practice Enrolment (Cluster)
Following HREC approval, primary care practices will be recruited to the study. Primary care practices will be sent information about the study through usual primary care communication channels. In addition, the researchers will inform GP practices about the study at professional talks or workshops, or by handing out information flyers to GP practices. They may also be recruited via information on social media platforms associated with Macquarie University (e.g. Lifespan Health & Wellbeing Research Centre, Centre for Ageing, Cognition & Wellbeing, Centre for Emotional Health, School of Psychology, MQ Health) and the Sydney North Primary Health Network, and GP professional networks. All GPs within a practice will have the option to volunteer to participate in the study, and each will be individually consented to be involved in the study.

Interventions
Patients will receive one of two interventions: 1) Ageing Well Tool or 2) Control Condition.
Patients will spend 30 minutes completing the survey on a tablet at the practice (e.g., in the waiting room) at each timepoint (baseline, 6 months post-baseline, 12 months post-baseline) before their consultation with their GP.
GPs will access the tool on a tablet at their practice. After patients fill out self-report measures (e.g., depression, social isolation), GPs will enter medical data on the tablet (e.g., cholesterol, hypertension).
In the Ageing Well Tool Condition following completion of the Risk Screening Survey, GPs will receive the personalised risk profile report for that patient on the tablet indicating patients’ risk factors that are present/absent and some evidence-based recommendations for risks that are present. For example, recommendations for a referral to a clinical psychologist or to an evidence-based treatment program will be provided to GPs to consider for the presence of anxiety and depressive symptomology. GPs will provide feedback to the patient on their results and, using patient-centred approaches and joint decision making, will plan the appropriate interventions, and provide them with a copy of the planned actions. At the next measurement 6 months later, the GP will receive a list of the previous recommendations they provided and will ask patients if they followed recommendations, recording this information in the Ageing Well Tool.
Following the 6 month and 12 month follow up risk screening, GPs and their patients will receive updated information on their current risk profile.


Training
GPs will receive a 30-minute training session (on premises or via videoconferencing) on how to use the tool from a postdoctoral researcher or research officer/assistant within one week prior to commencing the intervention at the GP practice (or as close to that timeframe as is practical for general practitioners). There will also be a summary of training materials on a website.

Acceptability and Feasibility of Ageing Well Tool (Mixed Methods approach)
To evaluate the acceptability and feasibility of the Ageing Well Tool, a research assistant will gather feedback on the screening and feedback process via an acceptability and feasibility measure comprising semi-structured qualitative focus group questions conducted with primary care staff and patients (separately), as described below. Audio will be transcribed verbatim by a MQ-approved transcription service (e.g., Digital Transcripts). Transcripts will be checked against audio files for accuracy. All data will be deleted from the transcription service once the transcription process is completed.

Primary care staff
GPs, practice manager(s), practice nurse(s) and other staff involved in patient care related to the Ageing Well Tool will be invited to provide feedback on the Ageing Well Tool via focus groups to assess their overall liking of the Ageing Well Tool, liking of aspects of the tool, how beneficial it is, barriers, potential solutions, and GP-observed patient compliance with the co-created treatment plan over 12 months. A sample of GPs and practice staff will be recruited from different locations and demographics to ensure focus group members are representative of the total sample.

Patients
A sample of patients will be invited to provide feedback on the Ageing Well Tool via focus groups to assess their overall liking of the Ageing Well Tool, liking of aspects of the tool, how beneficial it is, barriers, potential solutions, and patient self-report of compliance with the co-created treatment plan over 12 months. A sample of patients will be recruited from different locations and demographics to ensure focus group members are representative of the total sample.

In addition, all patients in the Ageing Well Tool condition will be asked to complete a 3-question mixed methods measure of acceptability and feasibility of the Ageing Well Tool following their 12-month assessment consultation.

Procedure: After HREC clearance, GP practices and practice staff will be recruited into the trial, and practices randomised via clusters into one of the two treatment conditions. GPs and practice staff will identify and recruit eligible participants into the trial and book them into an appointment to complete the risk screening survey. Participants will be contacted by the study RA to complete the cognitive screener (6 item), check study criteria, book the appointment for the cognitive testing and reconfirm participant consent. Participants will complete the neuropsychological tests in a dedicated 30 min session with the RA. For participants in practices allocated to the Ageing Well Tool, a personalised risk profile report will be presented to their GP who will then go through the results with the patient in a consultation and determine any treatment recommendations using the personalised Ageing Well Tool report.

All patients will recomplete the risk screening survey at 6- and 12-months post-baseline, and recomplete the cognitive testing at 12-months only (not at 6 months). Patients in the Ageing Well Tool condition will be invited to complete short acceptability and feasibility feedback on the Ageing Well Tool. A subgroup of consumers, practice nurses and GPs will be invited to participate in focus groups to understand acceptability, feasibility, barriers, and future improvements to the Ageing Well Tool. The Zoom/Teams focus groups will be audio recorded and transcribed. Following the 12-month risk survey, patients and their GPs in the control condition will receive a copy of the patient’s personalised risk profile and evidence-based treatment recommendations.
Intervention code [1] 327200 0
Early detection / Screening
Intervention code [2] 327201 0
Prevention
Intervention code [3] 327203 0
Treatment: Other
Comparator / control treatment
The Control Condition will consist of Treatment-as-Usual with Patient Self-Help. GPs will be able to conduct any of their own assessments or make recommendations to manage risks using treatment as usual approaches. Following the 12-month risk survey, patients and their GPs will receive a copy of the patient’s risk profile and evidence-based recommendations (as per the Ageing Well Tool condition).
For participants in practices allocated to treatment-as-usual with self-help control condition, after the survey completion they will receive a generic handout listing the known risk factors for dementia and poor wellbeing in later life and tips on how to reduce risk.
The handout has been specifically designed for this study. It contains several evidence-based recommendations for each risk factor.
Control group
Active

Outcomes
Primary outcome [1] 336333 0
Primary Outcome: Number of Risk Factors
The primary outcome is changes in the number of risk factors identified between the two conditions from baseline to 12 months post-baseline.


Timepoint [1] 336333 0
Measured by risk screening at 12-month post-baseline.
Secondary outcome [1] 427872 0
Secondary outcome 1: Cost effectiveness of The Ageing Well Tool treatment compared to treatment as usual (control condition) based on health economics analysis, at 12-month measurement, forecasting predicted health costs over the next 5-10 years.
Timepoint [1] 427872 0
12-month post-baseline.
Secondary outcome [2] 428747 0
Any change in encoding and laying down memories between conditions, at 12-month post-baseline measurement.
Timepoint [2] 428747 0
12-month post-baseline.
Secondary outcome [3] 428748 0
Any change in processing speed between conditions, at 12-month post-baseline measurement.
Timepoint [3] 428748 0
12-month post-baseline.
Secondary outcome [4] 429257 0
Any change in working memory between conditions, at 12-month post-baseline measurement.
Timepoint [4] 429257 0
12-month post-baseline
Secondary outcome [5] 429258 0
Any change in spatial ability related to hippocampal functioning between conditions, at 12-month post-baseline measurement.
Timepoint [5] 429258 0
12-month post-baseline
Secondary outcome [6] 429259 0
Any change in verbal fluency between conditions, at 12-month post-baseline measurement.
Timepoint [6] 429259 0
12-month post-baseline
Secondary outcome [7] 429260 0
GP perceived usefulness of Screening component of the Ageing Well Tool, at 12-month measurement.
Timepoint [7] 429260 0
12-month post-baseline
Secondary outcome [8] 429261 0
GP perceived usefulness of the Report and Recommendations component of the Ageing Well Tool, at 12-month measurement.
Timepoint [8] 429261 0
12-month post-baseline
Secondary outcome [9] 429262 0
GP barriers and suggestions for improvement and compliance, at 12-month measurement.
Timepoint [9] 429262 0
12-month post-baseline
Secondary outcome [10] 429263 0
Older adults’ perceived usefulness of the screening and report component of the Ageing Well Tool, at 12-month measurement.
Timepoint [10] 429263 0
12-month post-baseline
Secondary outcome [11] 429264 0
Older adults’ perceived usefulness of their management plan in reducing risks, at 12-month measurement.
Timepoint [11] 429264 0
12-month post-baseline
Secondary outcome [12] 429265 0
Older adults’ barriers and suggestions for improvement, at 12-month measurement.
Timepoint [12] 429265 0
12-month post-baseline

Eligibility
Key inclusion criteria
• The patient must be aged between 60 and 70 years of age (inclusive).
• Patient has a life expectancy of 5+ years from baseline assessment.
• Normal cognition based on 6-item screener.
• Patient of a General Practitioner in a practice who has signed up to the study.
• Lives independently in the community.
• Able to read and write in English at a sufficient level to enable informed written consent to be provided and capable of reading and responding to study questionnaires and resources).
Minimum age
60 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Patients who are <60 years of age or 71 years and older.
• Patients with a life expectancy of <5 years.
• Patients who have a significant medical condition that will prevent them from being able to actively engage in the study over the next 12 months.
• Patients with a dementia (based on medical record indicating existing dementia or based on score below threshold on the 6-item screener)
• Living in a residential aged care facility.
• Unable to read and write in English at a sufficient level.
• GP is not part of the trial.

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)
Allocation concealment will be done through sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomised (treatment vs. control randomised by practice).
Randomisation
Randomisation will happen at the cluster (GP practice) level not at the individual patient level. Therefore, all patients of any GP within an enrolled practice will receive the same intervention. This design increases feasibility and reduces contamination between the two interventions in the same practice. Practices will be randomised according to a randomisation schedule prepared by the study biostatistician not otherwise involved in the delivery of the intervention or data collection. Practices will be block randomised 1:1 to intervention or control arms in blocks of six to equalise numbers in both arms. An initial list of twenty-four random allocations will be produced, balanced after every six practices have been enrolled. Suitable practices will be randomly allocated by the Research Assistant off site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size is estimated by calculating the naïve sample size required (as though simple random sampling [SRS] was used) then multiplying that by the assumed design effect (Masood & Reidpath, 2016). A review of ICC values identified in relevant previous studies were generally low averaging 0.1. Based on a Cohen effect size of 0.5 being the lowest of scientific relevance and statistical power 0.8 at the 0.05 level of statistical significance (two-tailed), n=128 patients would be required under SRS. With an estimated design effect of 3.0, n=3 x 128 = 384 patients are required to be recruited.

Primary Outcome: Number of Risk Factors
The primary outcome is the number of risk factors for dementia and/or poor wellbeing present as measured by risk screening at 12-month post-baseline. Analysis will be conducted as intention-to-treat with all participant data analysed in the group they were randomised to.

The sampling design includes patients nested within general practices which are, in turn, nested within PHNs. Further, each practice is measured at three time points (baseline, 6-months and 12 months). The analysis will be undertaken using linear mixed models (multilevel models) that allow for the complex sampling scheme which is necessary when ICC values are greater than zero and the potentially confounding effect of underlying, extraneous time trends. The primary and secondary hypotheses will be evaluated via specific contrasts of study time points.

Descriptive analyses will be conducted (frequencies, means, medians, standard deviations and ranges) on demographic variables including age, gender, education, marital status, Aboriginal and/or Torres Strait Islander background, country of birth, English as a second language, and ethnicity to describe the representativeness of our sample. Further, number and type of recommendations and referrals provided by GPs and patient uptake will also be reported with descriptive analyses.

Secondary outcome 1: A within-trial cost effectiveness of The Ageing Well Tool treatment compared to treatment as usual (control condition) will be conducted by collecting patient level data on health outcomes measured by the EQ-5D-5L survey to patient level data on healthcare resource use derived from the Use of Care Services (UoCS) survey. A multivariable analysis of costs will be undertaken using a generalized linear model to account for the potential non-normal distribution of costs. Missing data will be imputed using various methods, depending on whether the missing data relates to the outcome or healthcare costs.

A healthcare system perspective will be taken within the analysis. Differences in health outcomes and cost over 12 months will be compared between the treatment and control groups, to develop an ICER that will be compared to a threshold of $50,000 per QALY. If the ICER is less than the threshold, The Ageing Well Tool will be deemed cost effective. Bootstrapping will be employed to derive the confidence intervals around outcomes and costs, while one-way and probabilistic sensitivity analysis will be conducted to estimate the sensitivity of the ICER to changing model parameters. A Cost Effectiveness Acceptability Curve (CEAC) will be constructed to determine the probability of The Ageing Well Tool being cost effective at different thresholds. The economic analysis will be reported using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.

Secondary outcome 2: Decline in episodic memory, and general cognitive abilities between conditions, at 12-month post-baseline measurement. Outcomes will be examined using linear mixed models.

Secondary outcome 3: Older adult and GP satisfaction with the Ageing Well Tool treatment condition, at 12-month measurement.
Qualitative interview statistical analysis plan and rationale: Two coders will read the transcripts and identify the most common themes using using thematic analysis (Clarke et al., 2015) related to measures of overall liking of the Ageing Well Tool, liking of aspects of the tool, how beneficial it is, barriers, potential solutions, and patient self-report of compliance with the co-created treatment plan over 12 months. Coders will discuss any differences in identified themes and agree on common themes, also agreeing on operational definitions of each theme. Both coders will then code all of the data on the final themes using the definitions. Percentage of overlap in coding data will be calculated to determine consistency between coders. This approach will provide the most unbiased analysis of consumers’ and primary care staff’s experiences with using the Ageing Well Tool.
In addition, the brief 3-question mixed methods measure sent to all patients in the Ageing Well Tool treatment condition for acceptability and feasibility feedback will be analysed using the same coding procedure for qualitative data and descriptive information will be provided for quantitative variables (frequencies, means, medians, standard deviations and ranges).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/12/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
384
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314874 0
Government body
Name [1] 314874 0
Australian Department of Health and Aged Care, Medical Research Future Fund Emerging Leadership Fellowship
Country [1] 314874 0
Australia
Funding source category [2] 315025 0
Charities/Societies/Foundations
Name [2] 315025 0
The Ian Potter Foundation grant
Country [2] 315025 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, Balaclava Road North Ryde NSW, 2109
Country
Australia
Secondary sponsor category [1] 316873 0
None
Name [1] 316873 0
Address [1] 316873 0
Country [1] 316873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313874 0
Macquarie University Human Research Ethics Committee (HREC) (Medical Sciences)
Ethics committee address [1] 313874 0
Macquarie University Balaclava Road, North Ryde, NSW, 2109 Australia
Ethics committee country [1] 313874 0
Australia
Date submitted for ethics approval [1] 313874 0
18/09/2023
Approval date [1] 313874 0
26/10/2023
Ethics approval number [1] 313874 0
520231607553698

Summary
Brief summary
This is a multisite, pragmatic cluster randomised trial. We will compare the (1) Ageing Well Tool that incorporates a personalised report (provided to GPs and patients) that outlines the presence/absence of personalised risk factors coupled with clinical treatment recommendations and management plans, to (2) a treatment-as-usual with a self-help control condition. N = 384 patients (n = 192 for each condition) will be enrolled in the study. We expect the The Ageing Well Tool will result in significantly greater reductions in the number of risk factors present from baseline to 12-month screening compared to the control condition. The Ageing Well Tool will also result in increased healthcare costs and improved health outcomes based on activities undertaken by participants to change dementia risk factors, significantly reduced cognitive decline on neuropsychological measures, and older adult and GP satisfaction with the Ageing Well Tool treatment condition will be high with few significant barriers, at 12-month measurement.
Trial website
Trial related presentations / publications
Public notes
Patient Enrolment
Any patient in an enrolled practice who meets the inclusion criteria and none of the exclusion criteria will be eligible to participate. Patients will be identified by practice staff and GPs in enrolled practices. Patients will be given a copy of the PICF via email or via paper and time to consider their involvement in the study. Interested participants will then be booked by practice staff to attend an appointment with the GP to conduct the risk screening. Participants will complete the PICF prior to risk screening.

Risk Screening Survey
Screening will be delivered via an Macquarie University-approved survey software (e.g., Qualtrics) administered on a tablet, smart phone or computer in the GP practice. The survey collects from patients self-reported data such as demographic information and validated self-report questionnaires, as well as medical data for cardiovascular risk, body mass index, diabetes, cholesterol and smoking using participants’ Participant Study ID, not their Medical Record Number.
• Demographics (age, gender, education, marital status, Aboriginal and Torres Strait Islander background, country of birth, English as a second language, ethnic identification; 8 items)
• Depression (GDS-15)
• Anxiety (GAS-10)
• Alcohol use (single item)
• Wellbeing (EQ-5D-5L)
• Use of services questionnaire (26 items)
• Social isolation (Lubben Social Network Scale- LSNS-6)
• DeJong Loneliness scale (6-item)
• Frail Scale (falls and head injury risk; 5 items)
• Cognitive engagement (mental stimulation) - ANU-ADRI 11-item Leisure Time Cognitive Stimulation measure)
• Fish consumption (single item)
• Insomnia Severity Index 7-item)
• Physical activity items from the Australian National University – Alzheimer’s Disease Risk Index (ANU-ARDI) short form (questions reworded to 3-items)
• Hearing loss (single item from blue mountains study, Sindhusake et al., 2001)

Neuropsychological Functioning
Following receipt of patient consent, the Research Assistant (RA) will contact patients to reconfirm patient consent (verbally), remind them that participation in voluntary, answer any remaining questions they have, conduct the 6-item screener and confirm all other eligibility for the study. In addition, they will arrange a time for the patient to attend the 30-minute cognitive functioning assessment. The measures of cognitive functioning will be:
• Rey Auditory Visual Learning Test (RAVLT)
• Symbol Digit Modalities Test (SDMT) – Oral Version
• Wechsler Digit forwards and backwards
• Rey Complex Figure Test
• Controlled Oral Word Association Test (COWAT also known as the FAS), as well as naming animals for semantic fluency.

Contacts
Principal investigator
Name 129626 0
Prof Viviana Wuthrich
Address 129626 0
Macquarie University, School of Psychological Sciences, Australian Hearing Hub, Level 2, 16 University Avenue, Macquarie University NSW 2109
Country 129626 0
Australia
Phone 129626 0
+61 2 9850 4866
Fax 129626 0
Email 129626 0
Viviana.Wuthrich@mq.edu.au
Contact person for public queries
Name 129627 0
Dr Diana Matovic
Address 129627 0
Macquarie University, School of Psychological Sciences, Australian Hearing Hub, Level 2, 16 University Avenue, Macquarie University NSW 2109
Country 129627 0
Australia
Phone 129627 0
+61 2 9850 8655
Fax 129627 0
Email 129627 0
Diana.Matovic@mq.edu.au
Contact person for scientific queries
Name 129628 0
Dr Diana Matovic
Address 129628 0
Macquarie University, School of Psychological Sciences, Australian Hearing Hub, Level 2, 16 University Avenue, Macquarie University NSW 2109
Country 129628 0
Australia
Phone 129628 0
+61 2 9850 8655
Fax 129628 0
Email 129628 0
Diana.Matovic@mq.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
Risk of identification of participants highly sensitive data including linked qualitative data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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