Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-12 DOI:10.1016/j.conctc.2025.101457

Carrington CJ. Shepherd , Melissa A. Dunham , Lina Gubhaju , Karen E. Lamb , Digsu N. Koye , Phoebe Fitzpatrick , Emily Banks , Kaarin J. Anstey , Melinda Carrington , Daniel McAullay , Ofra Kalter-Leibovici , Grace Joshy , Lesley Nelson , Jason Agostino , Ellie Paige , Kathleen Abu-Saad , Elise Alexander , Rona MacNiven , Kelsey Griffen , Fiona Collins , Sandra Eades

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引用次数: 0

Abstract

Background

Limited available data indicate that dementia prevalence rates among Aboriginal and Torres Strait Islander (hereafter Aboriginal) peoples are 3–5 times higher than the overall Australian population. Effective, pragmatic and scalable interventions are urgently required to address this disproportionate burden of dementia in Aboriginal populations.

Methods

Kaat Koort is a pragmatic two-arm parallel-group randomized controlled trial which will recruit a sample of 354 participants from two Aboriginal community-controlled health services in the south-west of Western Australia. Eligible participants are aged 35–60 years with risk factors for cardiovascular disease. Participants will be randomized in a 1:1 ratio to receive either a 12-month multifactorial lifestyle intervention (guided by Aboriginal Health Practitioners) that involves cardiovascular risk management, a lifestyle program targeting diet and physical activity, and support for smoking cessation and depression, or usual care (control). The primary endpoints are change in (i) systolic, and (ii) diastolic blood pressure. Secondary endpoints are changes in other cardiovascular risk factors (elevated blood pressure, HDL cholesterol, HbA1c, waist circumference, and absolute cardiovascular risk score), cognitive functioning, and adherence to Australian dietary and physical activity guidelines. Outcomes will be collected at baseline, and 6- and 12-months post-baseline.

Discussion

This trial aims to determine the efficacy of a multifactorial lifestyle intervention in reducing blood pressure among Aboriginal people aged 35–60 years at risk of dementia.

Trial registration number

ACTRN12621001022853; Australian New Zealand Clinical Trial Registry identifier.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.