卡特试验：一项多因素、多学科的由原住民健康从业者主导的原住民痴呆症预防干预实用随机对照试验的研究方案。

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

作者信息

Shepherd Carrington Cj, Dunham Melissa A, Gubhaju Lina, Lamb Karen E, Koye Digsu N, Fitzpatrick Phoebe, Banks Emily, Anstey Kaarin J, Carrington Melinda, McAullay Daniel, Kalter-Leibovici Ofra, Joshy Grace, Nelson Lesley, Agostino Jason, Paige Ellie, Abu-Saad Kathleen, Alexander Elise, MacNiven Rona, Griffen Kelsey, Collins Fiona, Linforth-Milham Salena, Gilbert Dolores, Prior Cindy, Rind Sadia, Douglas Richelle, Eades Sandra

机构信息

Curtin Medical School, Curtin University, Kent Street, 6102, Bentley, Australia.

Ngangk Yira Institute, Murdoch University, South Street, 6150, Murdoch, Australia.

出版信息

Contemp Clin Trials Commun. 2025 Feb 12;44:101457. doi: 10.1016/j.conctc.2025.101457. eCollection 2025 Apr.

DOI:10.1016/j.conctc.2025.101457

PMID:40027277

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11872118/

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.

摘要

背景

现有有限数据表明，原住民和托雷斯海峡岛民（以下简称原住民）的痴呆症患病率比澳大利亚总人口高出3至5倍。迫切需要有效、务实且可扩展的干预措施来应对原住民中这种不成比例的痴呆症负担。

方法

“卡特·库尔特”是一项务实的双臂平行组随机对照试验，将从西澳大利亚西南部的两个原住民社区控制的健康服务机构招募354名参与者。符合条件的参与者年龄在35至60岁之间，有心血管疾病风险因素。参与者将按1:1的比例随机分组，接受为期12个月的多因素生活方式干预（由原住民健康从业者指导），包括心血管风险管理、针对饮食和身体活动的生活方式计划，以及戒烟和抑郁症支持，或接受常规护理（对照组）。主要终点是（i）收缩压和（ii）舒张压的变化。次要终点是其他心血管风险因素（血压升高、高密度脂蛋白胆固醇、糖化血红蛋白、腰围和绝对心血管风险评分）、认知功能的变化，以及对澳大利亚饮食和身体活动指南的依从性。将在基线、基线后6个月和12个月收集结果。