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

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 dis...

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Main Authors: 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, Salena Linforth-Milham, Dolores Gilbert, Cindy Prior, Sadia Rind, Richelle Douglas, Sandra Eades
Format: Article
Language:English
Published: Elsevier 2025-04-01
Series:Contemporary Clinical Trials Communications
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Online Access:http://www.sciencedirect.com/science/article/pii/S2451865425000316
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author 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
Salena Linforth-Milham
Dolores Gilbert
Cindy Prior
Sadia Rind
Richelle Douglas
Sandra Eades
author_facet 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
Salena Linforth-Milham
Dolores Gilbert
Cindy Prior
Sadia Rind
Richelle Douglas
Sandra Eades
author_sort Carrington CJ. Shepherd
collection DOAJ
description 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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spelling doaj-art-437aeb08a3d24c6f801a16f950a6e7182025-08-20T03:42:53ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-014410145710.1016/j.conctc.2025.101457Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention interventionCarrington CJ. Shepherd0Melissa A. Dunham1Lina Gubhaju2Karen E. Lamb3Digsu N. Koye4Phoebe Fitzpatrick5Emily Banks6Kaarin J. Anstey7Melinda Carrington8Daniel McAullay9Ofra Kalter-Leibovici10Grace Joshy11Lesley Nelson12Jason Agostino13Ellie Paige14Kathleen Abu-Saad15Elise Alexander16Rona MacNiven17Kelsey Griffen18Fiona Collins19Salena Linforth-Milham20Dolores Gilbert21Cindy Prior22Sadia Rind23Richelle Douglas24Sandra Eades25Curtin Medical School, Curtin University, Kent Street, 6102, Bentley, Australia; Ngangk Yira Institute, Murdoch University, South Street, 6150, Murdoch, Australia; The Kids Research Institute Australia, 15 Hospital Ave, Nedlands, 6009, Australia; Corresponding author. Curtin Medical School, Curtin University, Kent Street, 6102, Bentley, Australia.Curtin Medical School, Curtin University, Kent Street, 6102, Bentley, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207-221 Bouverie Street, 3010, Melbourne, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207-221 Bouverie Street, 3010, Melbourne, Australia; Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, 161 Barry St, 3010, Carlton, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207-221 Bouverie Street, 3010, Melbourne, Australia; Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, 161 Barry St, 3010, Carlton, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207-221 Bouverie Street, 3010, Melbourne, Australia; Methods and Implementation Support for Clinical Health (MISCH) Research Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, 161 Barry St, 3010, Carlton, AustraliaNational Centre for Epidemiology and Population Health, Australian National University, 62 Mills Rd, 2601, Acton, AustraliaSchool of Psychology, University of New South Wales, Mathews Building, 2052, Kensington, Australia; Neuroscience Research Australia (NeuRA), 139 Barker St, Randwick, 2031, Australia; UNSW Ageing Futures Institute, 2052, Kensington, AustraliaBaker Heart and Diabetes Institute, 75 Commercial Rd, 3004, Melbourne, Australia; Baker Department of Cardiometabolic Health, The University of Melbourne, Gratton St, 3010, Parkville, AustraliaKurongkurl Katitjin, Edith Cowan University, 2 Bradford St, Mount Lawley, 6050, AustraliaGertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, 52126, Ramat Gan, Israel; Epidemiology & Preventive Medicine Department, School of Public Health, Faculty of Medicine, Tel Aviv University, 69978, Tel Aviv, IsraelNational Centre for Epidemiology and Population Health, Australian National University, 62 Mills Rd, 2601, Acton, AustraliaSouth West Aboriginal Medical Service, 51/55 Forrest Avenue, 6230, Bunbury, AustraliaAcademic Unit of General Practice, Australian National University, 0200, Canberra, AustraliaNational Centre for Epidemiology and Population Health, Australian National University, 62 Mills Rd, 2601, Acton, Australia; Population Health Program, QIMR Berghofer Medical Research Institute, 300 Herston Rd, 4006, Herston, Australia; School of Public Health, University of Queensland, 266 Herston Rd, 4006, Herston, AustraliaGertner Institute for Epidemiology and Health Policy Research, Sheba Medical Center, 52126, Ramat Gan, IsraelCentre for Aboriginal Medical and Dental Health (CAMDH), Medical School, University of Western Australia, 35 Stirling Hwy, 6009, Crawley, AustraliaSchool of Population Health, Faculty of Medicine & Health, UNSW Sydney, 2052, Kensington, AustraliaSchool of Population Health, Faculty of Medicine & Health, UNSW Sydney, 2052, Kensington, AustraliaSouth West Aboriginal Medical Service, 51/55 Forrest Avenue, 6230, Bunbury, AustraliaSouth West Aboriginal Medical Service, 51/55 Forrest Avenue, 6230, Bunbury, AustraliaDerbarl Yerrigan Health Service, 156 Wittenoom Street, East Perth, 6004, AustraliaThe Kids Research Institute Australia, 15 Hospital Ave, Nedlands, 6009, AustraliaDerbarl Yerrigan Health Service, 156 Wittenoom Street, East Perth, 6004, AustraliaDerbarl Yerrigan Health Service, 156 Wittenoom Street, East Perth, 6004, AustraliaCurtin Medical School, Curtin University, Kent Street, 6102, Bentley, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 207-221 Bouverie Street, 3010, Melbourne, AustraliaBackground: 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.http://www.sciencedirect.com/science/article/pii/S2451865425000316Aboriginal/Torres Strait Islander peoplesIndigenousRandomized controlled trialDementiaBlood pressureCardiovascular disease
spellingShingle 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
Salena Linforth-Milham
Dolores Gilbert
Cindy Prior
Sadia Rind
Richelle Douglas
Sandra Eades
Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention
Contemporary Clinical Trials Communications
Aboriginal/Torres Strait Islander peoples
Indigenous
Randomized controlled trial
Dementia
Blood pressure
Cardiovascular disease
title Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention
title_full Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention
title_fullStr Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention
title_full_unstemmed Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention
title_short Kaat koort: Study protocol for a pragmatic randomized controlled trial of a multifactorial, multidisciplinary Aboriginal Health Practitioner-led Aboriginal dementia prevention intervention
title_sort kaat koort study protocol for a pragmatic randomized controlled trial of a multifactorial multidisciplinary aboriginal health practitioner led aboriginal dementia prevention intervention
topic Aboriginal/Torres Strait Islander peoples
Indigenous
Randomized controlled trial
Dementia
Blood pressure
Cardiovascular disease
url http://www.sciencedirect.com/science/article/pii/S2451865425000316
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