TY - JOUR
T1 - METHODOLOGICAL ISSUES IN A CLUSTER-RANDOMIZED TRIAL TO PREVENT DEMENTIA BY INTENSIVE VASCULAR CARE
AU - Richard, E.
AU - Ligthart, S. A.
AU - Moll van Charante, E. P.
AU - van Gool, W. A.
PY - 2010
Y1 - 2010
N2 - Objectives: Description of methodological issues in a trial designed to evaluate if a multi-component intervention aimed at vascular risk factors can prevent dementia. Design, setting and participants: Multi-center, open, cluster-randomized controlled clinical trial (preDIVA) including 3535 non-demented subjects aged 70-78, executed in primary practice and coordinated from one academic hospital. General practices are randomized to standard care or intensive vascular care. Intervention: Vascular care consists of 4-monthly visits to a practice nurse who monitors all cardiovascular risk factors. Hypertension, hypercholesterolemia, overweight, lack of physical exercise and diabetes are strictly controlled according to a protocol and treated in a way, tailored to the characteristics of individual participants. Measurements: Primary outcomes are incident dementia and disability: secondary outcomes are mortality, vascular events (stroke, myocardial infarction, peripheral vascular disease). cognitive decline and depression. Results: Between May 2006 and February 2009, 3535 subjects from 115 general practices have been included. The clusters have an average size of 31 (SD 22, range 2-114). 1658 Patients from 52 practices were randomized to the standard care condition and 1877 patients in 63 practices to the vascular care condition. Discussion: When designing a cluster-randomized trial, clustering of patient data within GP practices leads to a loss of power. This should be adjusted for in the power calculation. Since intensive vascular care will probably lead to a reduction in cardiovascular mortality, the competing risks of mortality and dementia should be taken into account
AB - Objectives: Description of methodological issues in a trial designed to evaluate if a multi-component intervention aimed at vascular risk factors can prevent dementia. Design, setting and participants: Multi-center, open, cluster-randomized controlled clinical trial (preDIVA) including 3535 non-demented subjects aged 70-78, executed in primary practice and coordinated from one academic hospital. General practices are randomized to standard care or intensive vascular care. Intervention: Vascular care consists of 4-monthly visits to a practice nurse who monitors all cardiovascular risk factors. Hypertension, hypercholesterolemia, overweight, lack of physical exercise and diabetes are strictly controlled according to a protocol and treated in a way, tailored to the characteristics of individual participants. Measurements: Primary outcomes are incident dementia and disability: secondary outcomes are mortality, vascular events (stroke, myocardial infarction, peripheral vascular disease). cognitive decline and depression. Results: Between May 2006 and February 2009, 3535 subjects from 115 general practices have been included. The clusters have an average size of 31 (SD 22, range 2-114). 1658 Patients from 52 practices were randomized to the standard care condition and 1877 patients in 63 practices to the vascular care condition. Discussion: When designing a cluster-randomized trial, clustering of patient data within GP practices leads to a loss of power. This should be adjusted for in the power calculation. Since intensive vascular care will probably lead to a reduction in cardiovascular mortality, the competing risks of mortality and dementia should be taken into account
U2 - https://doi.org/10.1007/s12603-010-0072-3
DO - https://doi.org/10.1007/s12603-010-0072-3
M3 - Article
C2 - 20306005
SN - 1279-7707
VL - 14
SP - 315
EP - 317
JO - journal of nutrition, health & aging
JF - journal of nutrition, health & aging
IS - 4
ER -