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,
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
Affiliations
Amanda J Cross
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville Campus, Parkville, Victoria, Australia
Christine Walker
Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Melbourne, Victoria, Australia
Kaarin J Anstey
School of Psychology, University of New South Wales, Sydney, New South Wales, Australia
Kevin Mc Namara
3 School of Medicine, Deakin University, Burwood, Victoria, Australia
Vincent Versace
Deakin Rural Health, Deakin University, Warnambool, Victoria, Australia
Parker Magin
2 NSW & ACT Research and Evaluation Unit, GP Synergy Ltd - Newcastle, Mayfield West, New South Wales, Australia
Billie Bonevski
The NHMRC Centre of Research Excellence on Achieving the Tobacco Endgame, School of Public Health, The University of Queensland, Brisbane, Queensland, Australia
Amanda L Baker
2 Food and Nutrition Research Program, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
Elizabeth Manias
School of Nursing and Midwifery, Monash University, Clayton, Victoria, Australia
J Simon Bell
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Victoria, Australia
Marlien Varnfield
Australian eHealth Research Centre, CSIRO, Brisbane, Queensland, Australia
Stephanie A Ward
3 Centre for Healthy Brain Ageing, University of New South Wales, Sydney, New South Wales, Australia
Dennis Thomas
Priority Research Centre for Healthy Lungs, The University of Newcastle Hunter Medical Research Institute, New Lambton, New South Wales, Australia
Johnson George
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia
Rohan A Elliott
1 Bolton Clarke (formerly Royal District Nursing Service), St Kilda, Victoria, Australia
Rajiv Jayasena
2 The Australian e-Health Research Centre, CSIRO, Melbourne, VIC, Australia
Kali Godbee
The Department of General Practice, Melbourne Medical School, The University of Melbourne, Carlton, Victoria, Australia
Ajay Mahal
Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
Sharleen L O'Reilly
9Centre for Physical Activity and Nutrition Research, Deakin University, Melbourne Burwood Campus, Burwood, Victoria, Australia
Gopisankar Mohanannair Geethadevi
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia
Cik Y Lee
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia
Denise van den Bosch
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia
Mary Tullipan
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia
Catherine Ferreira
North Western Melbourne Primary Health Network, Parkville, Victoria, Australia
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.
