Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial
van Charante, Eric P. Moll
Eurelings, Lisa S.
van Dalen, Jan-Willem
Ligthart, Suzanne A.
van Bussel, Emma F.
Hoevenaar-Blom, Marieke P.
van Gool, Willem A.
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van Charante, E. P. M., Richard, E., Eurelings, L. S., van Dalen, J., Ligthart, S. A., van Bussel, E. F., Hoevenaar-Blom, M. P., et al. (2016). Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. The Lancet, 388 (10046), 797-805. https://doi.org/10.1016/S0140-6736(16)30950-3
This is the author accepted manuscript. The final version is available from Elsevier via https://doi.org/10.1016/ S0140-6736(16)30950-3
Background Cardiovascular risk factors are associated with an increased risk of dementia. We assessed whether a multidomain intervention targeting these factors can prevent dementia in a population of community-dwelling older people. Methods: In an open-label cluster randomised controlled trial with blinded outcome adjudication we recruited individuals aged 70–78 years through general practices (GPs). Computer-generated allocation was done for all GP practices within each health care centre (HCC), assigning them to a 6-year nurse-led, multidomain cardiovascular intervention or a control group (usual care). Primary outcomes were cumulative dementia incidence and disability. Main secondary outcomes were incident cardiovascular disease (CVD) and mortality. Primary analyses were by intention to treat. International Clinical Trials Registry, number ISRCTN29711771. Findings Between June 2006 and March 2009, 116 GPs (3526 persons) within 26 HCCs were recruited and randomly assigned: 63 (n=1890) to the intervention and 53 (n=1636) to the control group. Primary outcome data were obtained for 3454 persons (98%); median follow-up of was 6∙7 years 47 (21,341 person-years). Dementia developed in 6∙5% of intervention vs. 7∙0% of control participants (HR 0∙92, 95%CI 0∙71-1∙19, p=0∙54). There was no difference in disability, mortality or incident CVD. In participants with baseline hypertension, systolic blood pressure decreased more in the intervention group (adjusted mean difference -2∙93 mmHg, 95%CI -4.29;-1∙57). Interpretation In the preDIVA study population, a nurse-led, multidomain intervention did not result in a reduced incidence of all-cause dementia. Treatment contrast may have been insufficient because of modest baseline cardiovascular risks and high standards of usual care. Therefore, our results do not rule out clinically meaningful effects in adherent persons with untreated hypertension. Funding Ministry of Health, Innovation Fund of Collaborative Health Insurances, Organisation for Health Research and Development, all from the Netherlands.
We sincerely thank all participants of the PreDIVA study. The preDIVA Trial was supported by the Dutch Ministry of Health, Welfare and Sports (grant number 50-50110-98-020), the Dutch Innovation Fund of Collaborative Health Insurances (grant number 05-234), and Netherlands Organisation for Health Research and Development (grant number 62000015).
External DOI: https://doi.org/10.1016/S0140-6736(16)30950-3
This record's URL: https://www.repository.cam.ac.uk/handle/1810/260322
Attribution-NonCommercial-NoDerivatives 4.0 International
Licence URL: http://creativecommons.org/licenses/by-nc-nd/4.0/
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