A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial
Introduction Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for P...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e073709.full |
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| author | Amanda J Cross Christine Walker Kaarin J Anstey Kevin Mc Namara Vincent Versace Parker Magin Billie Bonevski Amanda L Baker Elizabeth Manias J Simon Bell Marlien Varnfield Stephanie A Ward Dennis Thomas Johnson George Rohan A Elliott Rajiv Jayasena Kali Godbee Ajay Mahal Sharleen L O'Reilly Gopisankar Mohanannair Geethadevi Cik Y Lee Denise van den Bosch Mary Tullipan Catherine Ferreira |
| author_facet | Amanda J Cross Christine Walker Kaarin J Anstey Kevin Mc Namara Vincent Versace Parker Magin Billie Bonevski Amanda L Baker Elizabeth Manias J Simon Bell Marlien Varnfield Stephanie A Ward Dennis Thomas Johnson George Rohan A Elliott Rajiv Jayasena Kali Godbee Ajay Mahal Sharleen L O'Reilly Gopisankar Mohanannair Geethadevi Cik Y Lee Denise van den Bosch Mary Tullipan Catherine Ferreira |
| author_sort | Amanda J Cross |
| collection | DOAJ |
| description | Introduction Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting.Methods and analysis General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45–65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia.Ethics and dissemination Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time.Trial registration number ACTRN12621001168842. |
| format | Article |
| id | doaj-art-1c8b89e65fa54b39a5683f731031eb10 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-1c8b89e65fa54b39a5683f731031eb102025-08-20T03:11:11ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-073709A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trialAmanda J Cross0Christine Walker1Kaarin J Anstey2Kevin Mc Namara3Vincent Versace4Parker Magin5Billie Bonevski6Amanda L Baker7Elizabeth Manias8J Simon Bell9Marlien Varnfield10Stephanie A Ward11Dennis Thomas12Johnson George13Rohan A Elliott14Rajiv Jayasena15Kali Godbee16Ajay Mahal17Sharleen L O'Reilly18Gopisankar Mohanannair Geethadevi19Cik Y Lee20Denise van den Bosch21Mary Tullipan22Catherine Ferreira23Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaMelbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, AustraliaNeuroscience Research Australia, University of New South Wales, Sydney, New South Wales, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaDeakin Rural Health, Deakin University, Warnambool, Victoria, AustraliaSchool of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia6 Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia2 Food and Nutrition Research Program, Hunter Medical Research Institute, New Lambton Heights, New South Wales, AustraliaSchool of Nursing and Midwifery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia2 Australian e-Health Research Centre, CSIRO, Brisbane, Queensland, AustraliaCentre for Healthy Brain Ageing, School of Psychiatry, University of New South Wales, Sydney, New South Wales, AustraliaPriority Research Centre for Healthy Lungs, The University of Newcastle Hunter Medical Research Institute, New Lambton, New South Wales, AustraliaSchool of Public Health and Preventive Medicine, Faculty of Medicine Nursing and Health Sciences, Monash University, St Kilda, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaThe Australian e-Health Research Centre, Health and Biosecurity, CSIRO, Parkville, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaThe Nossal Global Institute for Global Health, University of Melbourne, Melbourne, Victoria, AustraliaSchool of Agriculture and Food Science, University College Dublin, Dublin, IrelandCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, AustraliaNorth Western Melbourne Primary Health Network, Parkville, Victoria, AustraliaIntroduction Middle-aged multidomain risk reduction interventions targeting modifiable risk factors for dementia may delay or prevent a third of dementia cases in later life. We describe the protocol of a cluster randomised controlled trial (cRCT), HAPPI MIND (Holistic Approach in Primary care for PreventIng Memory Impairment aNd Dementia). HAPPI MIND will evaluate the efficacy of a multidomain, nurse-led, mHealth supported intervention for assessing dementia risk and reducing associated risk factors in middle-aged adults in the Australian primary care setting.Methods and analysis General practice clinics (n≥26) across Victoria and New South Wales, Australia, will be recruited and randomised. Practice nurses will be trained to implement the HAPPI MIND intervention or a brief intervention. Patients of participating practices aged 45–65 years with ≥2 potential dementia risk factors will be identified and recruited (approximately 15 patients/clinic). Brief intervention participants receive a personalised report outlining their risk factors for dementia based on Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI) scores, education booklet and referral to their general practitioner as appropriate. HAPPI MIND participants receive the brief intervention as well as six individualised dementia risk reduction sessions with a nurse trained in motivational interviewing and principles of behaviour change, a personalised risk reduction action plan and access to the purpose-built HAPPI MIND smartphone app for risk factor self-management. Follow-up data collection will occur at 12, 24 and 36 months. Primary outcome is ANU-ADRI score change at 12 months from baseline. Secondary outcomes include change in cognition, quality of life and individual risk factors of dementia.Ethics and dissemination Project approved by Monash University Human Research Ethics Committee (ID: 28273). Results will be disseminated in peer-reviewed journals and at healthcare conferences. If effective in reducing dementia risk, the HAPPI MIND intervention could be integrated into primary care, scaled up nationally and sustained over time.Trial registration number ACTRN12621001168842.https://bmjopen.bmj.com/content/13/12/e073709.full |
| spellingShingle | Amanda J Cross Christine Walker Kaarin J Anstey Kevin Mc Namara Vincent Versace Parker Magin Billie Bonevski Amanda L Baker Elizabeth Manias J Simon Bell Marlien Varnfield Stephanie A Ward Dennis Thomas Johnson George Rohan A Elliott Rajiv Jayasena Kali Godbee Ajay Mahal Sharleen L O'Reilly Gopisankar Mohanannair Geethadevi Cik Y Lee Denise van den Bosch Mary Tullipan Catherine Ferreira A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial BMJ Open |
| title | A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial |
| title_full | A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial |
| title_fullStr | A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial |
| title_full_unstemmed | A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial |
| title_short | A novel, multidomain, primary care nurse-led and mHealth-assisted intervention for dementia risk reduction in middle-aged adults (HAPPI MIND): study protocol for a cluster randomised controlled trial |
| title_sort | novel multidomain primary care nurse led and mhealth assisted intervention for dementia risk reduction in middle aged adults happi mind study protocol for a cluster randomised controlled trial |
| url | https://bmjopen.bmj.com/content/13/12/e073709.full |
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