A twelve-month programme in which practice nurses delivered personalised dementia-risk counselling, supported by a smartphone application, produced a modest but statistically significant improvement in estimated dementia-risk profiles among middle-aged Australian adults, according to a cluster randomised controlled trial published in The Lancet Regional Health – Western Pacific. The HAPPI MIND trial is, according to its investigators, the first Australian primary care trial to evaluate a nurse-led, multidomain behavioural intervention of this kind, and one of the first anywhere to target adults as young as 45 rather than people aged 60 and over.
The trial enrolled 403 community-dwelling adults aged 45 to 65 years who attended one of 31 general practice clinics in Victoria and New South Wales and who carried at least two modifiable dementia risk factors, such as hypertension, obesity or physical inactivity. Between February 2022 and April 2023, clinics were randomised so that 13 intervention and 18 control practices contributed participants. Participants had a mean age of 56.4 years, were predominantly female, and carried a median of five modifiable dementia risk factors at baseline. Their baseline estimated dementia risk, measured with the Australian National University Alzheimer’s Disease Risk Index (ANU-ADRI), was relatively low, with a mean total score of 1.91.
The intervention consisted of five practice nurse-led sessions delivered over twelve months, either face to face, by telephone or by video consultation, with a sixth booster session planned at 24 months. Nurses completed a two-day training programme covering motivational interviewing and cognitive-behavioural therapy principles, followed by three months of supervision. Each participant received an individualised dementia-risk report derived from their baseline ANU-ADRI assessment, identifying 14 modifiable risk factors, and then worked with the nurse to build a personalised action plan using specific, measurable goal-setting. Nurses addressed vascular factors such as hypertension, diabetes and dyslipidaemia, lifestyle factors including physical activity, diet, alcohol and smoking, and psychosocial domains such as social engagement, cognitive stimulation and mood. Participants also used a mobile health application, developed by the Commonwealth Scientific and Industrial Research Organisation, to self-monitor behaviours and track goals, while nurses reviewed progress through a clinician web dashboard.
Control participants received a single brief intervention at baseline: screening with the ANU-ADRI questionnaire, an individualised risk report, an educational booklet identical to that given to the intervention group, and advice to discuss identified risk factors with their general practitioner. They otherwise continued with usual care. Outcome assessors and data analysts remained blinded to group allocation throughout, although the nurses delivering the intervention and the participants themselves could not be blinded, an open-label design the investigators chose because the behavioural nature of the programme made masking unfeasible.
The primary outcome was the change in ANU-ADRI score from baseline to twelve months, where a reduction indicates a more favourable estimated dementia-risk profile. In the intention-to-treat analysis of 401 participants, after adjusting for prespecified baseline covariates including marital status, Indigenous status, socioeconomic status, comorbidity and hypertension, the intervention group improved by a mean of 1.60 points more than the control group (95% confidence interval 0.42 to 2.77; p = 0.008). Fifty-six per cent of intervention participants showed improvement on the primary outcome compared with 44 per cent of controls. The result was consistent in per-protocol analyses, which restricted the comparison to participants who attended at least four of five sessions and used the app for at least thirteen weeks, and in complete-case analyses. Retention at twelve months was 78 per cent in the intervention group and 88 per cent among controls.
A closer look at the sub-scores revealed where the benefit came from. The ANU-ADRI protective-factor sub-score, which captures health-promoting behaviours, improved significantly more in the intervention group (adjusted mean difference 1.56; 95% CI 0.44 to 2.68), whereas the risk-factor sub-score showed virtually no between-group difference (adjusted mean difference 0.04; p = 0.92). At the level of individual components, the intervention group showed significantly greater improvement in physical activity, fish intake and body mass index status. No significant between-group differences emerged for any of the secondary outcomes, which included a clinically derived risk score, cognitive performance on the Montreal Cognitive Assessment, quality of life, cardiovascular risk, depressive symptoms, dietary quality and diabetes risk. No participant received a diagnosis of dementia during the twelve-month follow-up.
Exploratory subgroup analyses suggested the effect was concentrated among certain participants. There was a statistically significant interaction by baseline dementia risk, with a between-group mean difference of 3.77 points among participants whose baseline ANU-ADRI score was 5 or higher, compared with essentially no difference among those with lower baseline risk. A significant interaction by socioeconomic status was also observed, with the largest point estimate in the low socioeconomic group, although its confidence interval crossed zero. The investigators caution that the trial was not powered to detect subgroup interactions and that these findings should be treated as hypothesis-generating. When nurses directly targeted a specific risk factor, the only factor showing a significantly greater improvement when targeted versus not targeted was social isolation.
The trial’s safety monitoring recorded seven adverse events during follow-up, including two deaths, one in each group, and five serious adverse events. Two serious adverse events in the intervention group, distress related to pre-existing disordered eating, were judged related to the intervention. Engagement with the digital component was variable: while 80 per cent of intervention participants attended at least four nurse sessions, only 35 per cent entered data into the app for thirteen weeks or more, and the study could not determine the independent contribution of the mobile application because the intervention was evaluated as an integrated package.
The investigators interpret their findings cautiously. The primary outcome is largely based on self-reported behaviours, and the open-label design means the results may be susceptible to social desirability and reporting bias, or to increased behavioural awareness prompted by repeated assessments and coaching. The absence of consistent changes in objective clinical measures, such as blood pressure, cholesterol and glucose, collected at baseline and twelve months, suggests that some of the observed effect may reflect changes in awareness or reporting rather than true behavioural modification. The modest baseline risk of the study population may also have limited the scope for further improvement, and the ANU-ADRI applies differential weighting to individual components, which should be considered when interpreting the magnitude of the change. A score reduction indicates a more favourable estimated risk profile, but does not directly demonstrate a reduction in dementia incidence.
Nevertheless, the trial demonstrates that a dementia-risk reduction programme can be delivered within existing Australian general practice infrastructure, using trained practice nurses and digital tools, without requiring the intensive supervision of earlier landmark prevention trials conducted in more structured research settings. The investigators note that embedding nurse-led dementia-risk assessment within existing chronic disease prevention frameworks may offer an efficient route to implementation, and that prevention modelling suggests even modest reductions in midlife risk factors could yield meaningful population-level benefit. They emphasise that formal implementation and economic evaluations are needed before broader adoption can be recommended, and that longer-term cognitive and clinical outcomes will be examined in the ongoing 36-month follow-up, which will clarify whether these early gains are sustained and whether they translate into clinically meaningful outcomes.
Subject of Research: A nurse-led, mobile health-supported multidomain intervention for dementia risk reduction in Australian primary care
Article 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
Article References: Sarwar, M. R., Godbee, K., Cross, A. J., Geethadevi, G. M., Magin, P., Baker, A. L., Bonevski, B., O'Reilly, S. L., Varnfield, M., Jayasena, R., Ward, S. A., Mahal, A., Versace, V., Simon Bell, J., Namara, K. M., Anstey, K. J., Hernan, A., Thomas, D., Manias, E., … George, J. (2026). 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. The Lancet Regional Health – Western Pacific, 75, Article 102000. https://doi.org/10.1016/j.lanwpc.2026.102000
Image Credits: AI Generated
DOI: 10.1016/j.lanwpc.2026.102000
Keywords: dementia risk reduction, primary care, cluster randomised controlled trial, practice nurses, mobile health, ANU-ADRI, motivational interviewing, behavioural intervention, midlife adults, Australia, HAPPI MIND, preventive health
News Source: Cassandra Pierce. (October 28, 2026). Nurse-led programme modestly improves dementia risk profiles in Australian primary care trial. Scienmag.
