Badenbroek Ilse F, Stol Daphne M, Nielen Marcus M J, Hollander Monika, Kraaijenhagen Roderik A, de Wit G Ardine, Schellevis François G, de Wit Niek J
Netherlands Institute for Health Services Research (NIVEL), P,O, Box 1568, 3500 BN Utrecht, The Netherlands.
BMC Fam Pract. 2014 May 9;15:90. doi: 10.1186/1471-2296-15-90.
The increasing prevalence of cardiometabolic disease (CMD) in combination with an ageing population is a major public health problem. Early detection and management of individuals at risk for CMD is required to prevent future health problems with associated costs. General practice is the optimal health care setting to accomplish this goal. Prevention programs for identification and treatment of patients with an increased risk for CMD in primary care have been proven feasible. However, the effectiveness and cost-effectiveness have yet to be demonstrated. The 'Personalized Prevention Approach for CardioMetabolic Risk' (PPA CMR) is such a prevention program. The objective of the INTEGRATE study is to investigate the effectiveness and cost-effectiveness of PPA CMR, as well as to establish determinants for participation and compliance.
The INTEGRATE study is designed as a stepped-wedge randomized controlled trial with a waiting list control group. In approximately 40 general practices, all enlisted patients without CMD aged 45-70 years, are invited to participate in PPA CMR. After an online risk estimation, patients with a score above risk threshold are invited to the GP for additional measurements, detailed risk profiling and tailored treatment of risk factors through medication and/or lifestyle counseling. At baseline and after twelve months of follow-up lifestyle, health and work status of all participants are established with online questionnaires. Additionally after twelve months, we will determine health care utilization, costs of PPA CMR and compliance. Primary endpoints are the number of newly detected patients with CMD and changes in individual risk factors between the intervention and waiting list control group. Medical data will be extracted from the GPs' electronic medical records. In order to assess factors related to participation, we will send questionnaires to non-participants and assess characteristics of participating practices. For all participants, additional demographic characteristics will be available through Statistics Netherlands.
The INTEGRATE study will provide insight into the effectiveness and cost-effectiveness of PPA CMR as well as determinants for participation and compliance, which represents essential information to guide further large-scale implementation of primary prevention programs for CMD.
NTR4277, The Netherlands National Trial Register, 26-11-2013.
心血管代谢疾病（CMD）患病率的上升与人口老龄化相结合，是一个重大的公共卫生问题。为预防未来出现相关成本的健康问题，需要对有CMD风险的个体进行早期检测和管理。全科医疗是实现这一目标的最佳医疗保健环境。在初级保健中识别和治疗CMD风险增加患者的预防项目已被证明是可行的。然而，其有效性和成本效益尚未得到证实。“心血管代谢风险个性化预防方法”（PPA CMR）就是这样一个预防项目。INTEGRATE研究的目的是调查PPA CMR的有效性和成本效益，并确定参与和依从的决定因素。
INTEGRATE研究设计为阶梯式楔形随机对照试验，设有一个等待名单对照组。在大约40家全科诊所中，邀请所有45 - 70岁无CMD的登记患者参与PPA CMR。经过在线风险评估后，得分高于风险阈值的患者被邀请到全科医生处进行额外测量、详细风险分析，并通过药物治疗和/或生活方式咨询对风险因素进行针对性治疗。在基线时以及随访12个月后，通过在线问卷确定所有参与者的生活方式、健康和工作状况。此外，在12个月后，我们将确定医疗保健利用率、PPA CMR的成本和依从性。主要终点是新检测出的CMD患者数量以及干预组和等待名单对照组之间个体风险因素的变化。医疗数据将从全科医生的电子病历中提取。为了评估与参与相关的因素，我们将向未参与者发送问卷，并评估参与诊所的特征。对于所有参与者，可通过荷兰统计局获取额外的人口统计学特征。
INTEGRATE研究将深入了解PPA CMR的有效性和成本效益以及参与和依从的决定因素，这是指导CMD初级预防项目进一步大规模实施的重要信息。
NTR****，荷兰国家试验注册库，2013年11月26日。 （注：原文中TRIAL REGISTRATION NUMBER部分的NTR4277未完整给出，这里保留原文格式）
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