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Effectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial
European Journal of Cardiovascular Nursing ( IF 2.9 ) Pub Date : 2020-12-01 , DOI: 10.1177/1474515120919547
Heleen Westland 1 , Marieke J Schuurmans 2 , Irene D Bos-Touwen 1 , Marjolein A de Bruin-van Leersum 1 , Evelyn M Monninkhof 1 , Carin D Schröder 3 , Daphne A de Vette 1 , Jaap Ca Trappenburg 1
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Background To understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care. Aim The aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect. Methods A two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity. Results Thirty-one general practices (n = 195 patients) were included (intervention group n = 93; control group n = 102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P = 0.28) and secondary outcomes. Patients with low perceived social support (P = 0.01) and patients with a low baseline activity level (P = 0.02) benefitted more from the intervention. Conclusion The Activate intervention did not improve patients’ physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation. Trial registration: ClinicalTrials.gov NCT02725203.

中文翻译:

护士主导的激活干预对初级保健中有心血管疾病风险的患者的有效性:一项集群随机对照试验

背景 为了更好地了解自我管理干预的成功,并能够针对特定患者亚组定制此类干预,护士主导的激活干预针对异质亚组(患者在心血管疾病风险)在荷兰初级保健中。目的 本研究的目的是评估激活干预的有效性,并确定哪些与患者相关的特征会改变效果。方法 进行了一项两臂整群随机对照试验,将干预与照常护理进行了比较。干预包括在 3 个月内进行四次由护士主导的行为改变咨询。在基线、3 个月和 6 个月时收集数据。主要结果是 6 个月时每天进行中度到剧烈体力活动的量。次要结果包括久坐行为、身体活动的自我效能、自我管理的患者激活和健康状况。预先指定的影响修正因素是年龄、体重指数、教育水平、社会支持、抑郁、患者提供者关系和基线身体活动。结果 共纳入 31 例全科医师(n = 195 名患者)(干预组 n = 93;对照组 n = 102)。体力活动(平均差异 2.49 分钟;95% 置信区间 -2.1;7.1;P = 0.28)和次要结果未发现显着组间差异。低感知社会支持(P = 0.01)和基线活动水平低(P = 0.02)的患者从干预中受益更多。结论 Activate 干预并未改善有心血管疾病风险的初级保健患者的身体活动和次要结局。要了解结果,需要进一步调查干预保真度和有效自我管理的积极成分。试验注册:ClinicalTrials.gov NCT02725203。
更新日期:2020-12-01
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