A multidomain, nurse-led, mobile health-supported intervention for dementia risk reduction in primary care (HAPPI MIND): a pragmatic, single-blind, two-arm, cluster randomised controlled trial
14 affiliations
- 1Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, 3052, Australia
- 2School of Medicine and Public Health, The University of Newcastle, Newcastle, NSW, 2308, Australia
- 3National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, 2031, Australia
- 4Flinders Health and Medical Research Institute, Flinders University, Bedford Park, SA, 5042, Australia
- 5School of Agriculture and Food Science, University College Dublin, Dublin, D04 V1W8, Ireland
- 6The Australian e-Health Research Centre, Health and Biosecurity, CSIRO, Herston, QLD, 4029, Australia
- 7The Australian e-Health Research Centre, Health and Biosecurity, CSIRO, Parkville, VIC, 3052, Australia
- 8Centre for Healthy Brain Ageing, University of New South Wales, Sydney, NSW, 2052, Australia
- 9Nossal Institute for Global Health, University of Melbourne, Melbourne, VIC, 3010, Australia
- 10Deakin Rural Health, School of Medicine, Faculty of Health, Deakin University, Warrnambool, VIC, 3280, Australia
- 11School of Psychology, University of New South Wales, Sydney, NSW, 2052, Australia
- 12Centre of Excellence in Treatable Traits, College of Health, Medicine and Wellbeing, University of Newcastle, Newcastle, NSW, 2305, Australia
- 13Monash Nursing and Midwifery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, VIC, 3800, Australia
- 14North Western Melbourne Primary Health Network, Docklands, VIC, 3008, Australia
Abstract
Background
Modifiable midlife risk factors contribute substantially to dementia, yet scalable preventive interventions in primary care are limited. We evaluated the effectiveness of a multidomain, nurse-led, mobile health (mHealth)-supported behavioural intervention (HAPPI MIND) among middle-aged adults.Methods
We conducted a cluster randomised controlled trial in adults aged 45-65 years with ≥2 modifiable dementia risk factors, from 31 Australian general practices (intervention = 13, control = 18). Clinics were randomised to the intervention or control group. Practice nurses collected socio-demographic and clinical data using validated tools. Participants completed the Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) dementia risk assessment, which assessed exposure to modifiable risks and protective factors for dementia. Intervention participants received five nurse-led motivational interviewing sessions over 12 months, an individualised action plan, and access to the mHealth application. Control participants received the ANU-ADRI report, an educational booklet on dementia risk reduction, and referral to their general practitioner as appropriate. Outcome assessors and data analysts were blinded. The primary outcome was the change in ANU-ADRI score from baseline to 12 months. Analyses followed intention-to-treat principles using linear mixed-effects models with multiple imputation for missing data. The trial was prospectively registered (ACTRN12621001168842); the intervention is complete, and this report presents the prespecified primary outcome at 12 months.Findings
Between February 2022 and April 2023, 403 participants (intervention = 201; control = 202) were enrolled (mean age 56.4 years [SD 5.7]; 63% female). At 12 months, the adjusted mean change in ANU-ADRI score was 0.791 (95% CI -0.895 to 2.478) in the intervention group and -0.807 (-2.339 to 0.725) in the control group, with an adjusted between-group mean difference of 1.598 (0.423-2.773; p = 0.0080), favouring the intervention. Results from per-protocol and complete-case analyses were consistent. Seven adverse events occurred, including two deaths (one in each group).Interpretation
A multidomain, nurse-led, mHealth-supported behavioural intervention produced modest but statistically significant improvements in estimated dementia risk profiles over 12 months among middle-aged adults in Australian primary care. Further implementation, processes, and economic evaluations are needed before broader adoption can be recommended.Funding
Australian Government National Health and Medical Research Council, Boosting Dementia Research Grants (GNT1171851).
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BibTeX
@article{sarwar2026multidomain,
title = {{A multidomain, nurse-led, mobile health-supported intervention for dementia risk reduction in primary care (HAPPI MIND): a pragmatic, single-blind, two-arm, cluster randomised controlled trial}},
author = {Muhammad Rehan Sarwar and Kali Godbee and Amanda J. Cross and Gopisankar Mohanannair Geethadevi and Parker Magin and Amanda L. Baker and Billie Bonevski and Sharleen L. O'Reilly and Marlien Varnfield and Rajiv Jayasena and Stephanie A. Ward and Ajay Mahal and Vincent Versace and J. Simon Bell and Kevin Mc Namara and Kaarin J. Anstey and Andrea Hernan and Dennis Thomas and Elizabeth Manias and Rohan A. Elliott and Cik Yin Lee and Mary Tullipan and Denise van den Bosch and Catherine Ferreira and Nina Nguyen and Tesfaye R. Feyissa and Johnson George},
journal = {The Lancet regional health. Western Pacific},
year = {2026},
month = oct,
doi = {10.1016/j.lanwpc.2026.102000},
url = {https://europepmc.org/article/PMC/PMC13717166},
note = {CC BY},
}
RIS
TY - JOUR
TI - A multidomain, nurse-led, mobile health-supported intervention for dementia risk reduction in primary care (HAPPI MIND): a pragmatic, single-blind, two-arm, cluster randomised controlled trial
AU - Muhammad Rehan Sarwar
AU - Kali Godbee
AU - Amanda J. Cross
AU - Gopisankar Mohanannair Geethadevi
AU - Parker Magin
AU - Amanda L. Baker
AU - Billie Bonevski
AU - Sharleen L. O'Reilly
AU - Marlien Varnfield
AU - Rajiv Jayasena
AU - Stephanie A. Ward
AU - Ajay Mahal
AU - Vincent Versace
AU - J. Simon Bell
AU - Kevin Mc Namara
AU - Kaarin J. Anstey
AU - Andrea Hernan
AU - Dennis Thomas
AU - Elizabeth Manias
AU - Rohan A. Elliott
AU - Cik Yin Lee
AU - Mary Tullipan
AU - Denise van den Bosch
AU - Catherine Ferreira
AU - Nina Nguyen
AU - Tesfaye R. Feyissa
AU - Johnson George
PY - 2026
DA - 2026/10/01
JO - The Lancet regional health. Western Pacific
DO - 10.1016/j.lanwpc.2026.102000
UR - https://europepmc.org/article/PMC/PMC13717166
AB - Background Modifiable midlife risk factors contribute substantially to dementia, yet scalable preventive interventions in primary care are limited. We evaluated the effectiveness of a multidomain, nurse-led, mobile health (mHealth)-supported behavioural intervention (HAPPI MIND) among middle-aged adults.Methods We conducted a cluster randomised controlled trial in adults aged 45-65 years with ≥2 modifiable dementia risk factors, from 31 Australian general practices (intervention = 13, control = 18). Clinics were randomised to the intervention or control group. Practice nurses collected socio-demographic and clinical data using validated tools. Participants completed the Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI) dementia risk assessment, which assessed exposure to modifiable risks and protective factors for dementia. Intervention participants received five nurse-led motivational interviewing sessions over 12 months, an individualised action plan, and access to the mHealth application. Control participants received the ANU-ADRI report, an educational booklet on dementia risk reduction, and referral to their general practitioner as appropriate. Outcome assessors and data analysts were blinded. The primary outcome was the change in ANU-ADRI score from baseline to 12 months. Analyses followed intention-to-treat principles using linear mixed-effects models with multiple imputation for missing data. The trial was prospectively registered (ACTRN12621001168842); the intervention is complete, and this report presents the prespecified primary outcome at 12 months.Findings Between February 2022 and April 2023, 403 participants (intervention = 201; control = 202) were enrolled (mean age 56.4 years [SD 5.7]; 63% female). At 12 months, the adjusted mean change in ANU-ADRI score was 0.791 (95% CI -0.895 to 2.478) in the intervention group and -0.807 (-2.339 to 0.725) in the control group, with an adjusted between-group mean difference of 1.598 (0.423-2.773; p = 0.0080), favouring the intervention. Results from per-protocol and complete-case analyses were consistent. Seven adverse events occurred, including two deaths (one in each group).Interpretation A multidomain, nurse-led, mHealth-supported behavioural intervention produced modest but statistically significant improvements in estimated dementia risk profiles over 12 months among middle-aged adults in Australian primary care. Further implementation, processes, and economic evaluations are needed before broader adoption can be recommended.Funding Australian Government National Health and Medical Research Council, Boosting Dementia Research Grants (GNT1171851).
SN - 2666-6065
ER -