Prevention of dementia by intensive vascular care in elderly patients. A study in general practice.

Dementia is one of the most dreaded syndromes in the elderly. Next to a dramatic impact on the personal life of patients and caregivers, it poses a high burden on social and economic resources. With an ageing population, the prevalence of dementia will continue to rise in the coming decades. Since effective treatments are lacking, the prevention of dementia deserves high priority. Observational studies have shown a strong association between cardiovascular risk factors and the incidence of Alzheimer disease as well as vascular dementia. Moreover, treatment of these risk factors is associated with a decreased incidence of dementia. Only few intervention trials have focussed on dementia as an outcome measure. Reports of intervention trials on antihypertensive medication are cautiously positive. However, to date it is still unknown if improvement of the cardiovascular risk profile in elderly will lead to a decrease in incident dementia. The pre-DIVA study (PREvention of Dementia by Intensive VAscular care) is designed to test this hypothesis. This open, cluster randomized intervention trial compares regular care by the general practitioner to a structured, nurse-led, multi-component intervention in primary care directed at vascular risk factors. Participants are monitored for six years and are screened every two years. In the intervention condition, participants consult a nurse practitioner every four months who addresses blood pressure, body weight, exercise status, diet, smoking habits and medication adherence based on national practice guidelines. Patients in the control arm receive care as usual. Primary endpoints of the pre-DIVA study are a clinical diagnosis of dementia and disability. Secondary outcomes are all cause mortality and vascular complications (stroke, myocardial infarction, peripheral vascular disease). Inclusion of patients in this prospective study started in November 2006 and ended in January 2009. In total, 3534 patients aged 70-79 years have been included. The proposed PhD stipendium will involve the interim analysis for incidence of dementia at 4 years and the cumulative incidence of fatal and non-fatal myocardial infarction, fatal and non-fatal ischemic stroke and peripheral vascular disease in the nurse-led intensive vascular care group compared to the control condition group. Since the intervention is likely to lead to higher medication adherence and prescription levels (for drugs lowering hypertension and cholesterol, anti-diabetic drugs and drugs aimed at antiplatelet therapy), adverse effects are also monitored closely in order to evaluate the overall risk-benefit ratio of the intervention as a whole. The PhD candidate is responsible for the reporting of baseline data, data management and outcome measurements. Also, a cost-effectiveness analysis will be initiated by the PhD candidate, as well as qualitative research of patient’s perspective of this intervention in practice.