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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

Year: 2026

Type: article

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).

Source: The Lancet Regional Health - Western Pacific

DOI: 10.1016/j.lanwpc.2026.102000