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.

Amanda J Cross, Gopisankar Mohanannair Geethadevi, Parker Magin, Amanda L Baker, Billie Bonevski, Kali Godbee, Stephanie A Ward, Ajay Mahal, Vincent Versace, J Simon Bell, Kevin Mc Namara, Sharleen L O'Reilly, Dennis Thomas, Elizabeth Manias, Kaarin J Anstey, Marlien Varnfield, Rajiv Jayasena, Rohan A Elliott, Cik Y Lee, Christine Walker, Denise van den Bosch, Mary Tullipan, Catherine Ferreira, Johnson George

Journal: BMJ open 2024;13(12):e073709

PMID: 38114278

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Abstract

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.

Address: Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.; School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia.; National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.; Flinders Health and Medical Research Institute, Flinders University, Bedford Park, South Australia, Australia.; Centre for Healthy Brain Ageing, University of New South Wales, Sydney, New South Wales, Australia.; School of Public Health and Preventive Medicine, Faculty of Medicine Nursing and Health Sciences, Monash University, St Kilda, Victoria, Australia.; Nossal Institute for Global Health, University of Melbourne, Melbourne, Victoria, Australia.; Deakin Rural Health, Faculty of Health, Deakin University, Warrnambool, Victoria, Australia.; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.; Deakin Rural Health, Faculty of Health, Deakin University, Warrnambool, Victoria, Australia.; School of Agriculture and Food Science, University College Dublin, Dublin, Ireland.; School of Exercise and Nutrition Science, Deakin University, Melbourne, Victoria, Australia.; Centre of Excellence in Treatable Traits, College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW, Australia.; Asthma and Breathing Research Program, Hunter Medical Research Institute, Newcastle, NSW, Australia.; School of Nursing and Midwifery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia.; School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.; UNSW Ageing Futures Institute, University of New South Wales, Sydney, New South Wales, Australia.; The Australian e-Health Research Centre, Health and Biosecurity, CSIRO, Herston, Queensland, Australia.; The Australian e-Health Research Centre, Health and Biosecurity, CSIRO, Parkville, Victoria, Australia.; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.; Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia.; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.; Department of Nursing, School of Health Sciences, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.; Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia.; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.; School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia.; North Western Melbourne Primary Health Network, Parkville, Victoria, Australia.; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia [email protected].; School of Public Health and Preventive Medicine, Faculty of Medicine Nursing and Health Sciences, Monash University, St Kilda, Victoria, Australia.

DOI: 10.1136/bmjopen-2023-073709

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https://medlineplus.gov/dementia.html

MeSH Terms: Humans, Middle Aged, Dementia, Primary Care Nursing, Quality of Life, Randomized Controlled Trials as Topic, Risk Reduction Behavior, Telemedicine, Victoria, Aged