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Implementing innovative technology promoting self-awareness of brain health and self-determination in obtaining a timely dementia diagnosis: protocol for a multimethods, concurrent, two-part observational study

Por: Hutchinson · A. M. · Macpherson · H. · Petrovich · T. · Vasa · R. · Chong · T. W. H. · Engel · L. · Botha · T. · Bucknall · T. K. · Burns · K. · Daly · S. · Lomas · J. · Mouzakis · K. · Mowszowski · L. · Naismith · S. L. · Redley · B. · Rivera Villicana · J. · Vouliotis · A. · Yuen · E.
Introduction

Diagnosis in the early stages of dementia can lead to successful delay in associated cognitive decline. However, up to 76% of Australians diagnosed with dementia have already advanced beyond the early stage of disease. BrainTrack is an evidence-based mobile application (app) designed in Australia to promote brain health self-awareness, self-determination to promote help-seeking and, ultimately, a timelier dementia diagnosis. We will evaluate user experience, implementation and social return-on-investment outcomes of BrainTrack and will report dementia-related concerns, dementia literacy, knowledge, stigma and motivation for behaviour change and explore their associations with demographic characteristics.

Methods and analysis

A multimethods, concurrent, two-study observational design will be used. Study 1 will evaluate BrainTrack user experience and implementation outcomes, changes in users’ dementia literacy, dementia knowledge, perceptions of dementia-related stigma and help-seeking at five time points (baseline, 1, 3, 6 and 12 months). People residing in all states and territories of Australia will be recruited to the study via the BrainTrack app. Data collection will occur online and through teleconferencing. Approximately 1000 participants will complete all five surveys. Google Analytics data will measure adoption. App usage data will identify app use patterns. A sample of continuing app users (~n=80) and those who cease app use within 6 months (~n=20) will be interviewed to obtain in-depth information about their app use and help-seeking experience. Dementia Australia Helpline data will quantify help-seeking calls triggered by BrainTrack use. In Study 1, longitudinal outcomes will be analysed using mixed models. The economic and social value of BrainTrack will be assessed using social return on investment analysis. In Study 2, general practitioners (~n=20) currently practising in Australia will participate in semi-structured interviews conducted via online teleconferencing. Interviews will elicit perceptions of the usefulness of BrainTrack for initiating and facilitating discussions with patients about cognition and dementia. Qualitative data will be analysed thematically, followed by deductive analysis guided by the Theoretical Domains Framework.

Ethics and dissemination

This study has received Human Research Ethics Committee approval from Deakin University Human Research Ethics Committee (Study 1: HREC Reference Number 2022–220) and Deakin University Human Ethics Advisory Group, Faculty of Health (Study 2: Reference Number 202_2022). Informed consent will be obtained prior to participation, either verbally for interviews or online for surveys. Study findings will be published in peer-reviewed journals and communicated to key stakeholders.

STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection

Por: Delfino · C. · Carcel · C. · Lin · X. · Munoz-Venturelli · P. · Naismith · S. L. · Woodward · M. · Peters · R. · Wijesuriya · N. · Law · M. · Harding · I. H. · Wang · X. · Elliott · J. · Leder · K. · Hutchings · O. · Stecher · X. · Zoungas · S. · Anderson · C. S.
Introduction

Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.

Methods and analysis

The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.

Ethics and dissemination

This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.

Trial registration number

The study protocol is registered at Clinicaltrials.gov (NCT04904536).

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