Neupane Dinesh, McLachlan Craig S, Christensen Bo, Karki Arjun, Perry Henry B, Kallestrup Per
Center for Global Health, Department of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Rural Clinical School, University of New South Wales, Samuels Building, Sydney, NSW, 2052, Australia.
Trials. 2016 Jun 18;17(1):292. doi: 10.1186/s13063-016-1412-3.
Hypertension contributes to a significant burden of cardiovascular disease in low- and middle-income countries; however, responses are inadequate because of a lack of conclusive evidence on population-based approaches to hypertension control.
METHODS/DESIGN: The objective of the present study is to determine the effect of family-based home health education and blood pressure monitoring by trained female community health volunteers. The primary outcome is change in mean systolic blood pressure. A community-based, open-masked, two-armed, cluster-randomized trial will be conducted in Lekhnath Municipality of Nepal. The municipality is divided into 15 administrative clusters. Randomization will be conducted for 14 clusters: 7 for the intervention arm and 7 for the control arm. The participants were recruited from a prevalence study conducted earlier. On the basis of population proportion size, 929 individuals for the intervention group and 709 individuals for the control group will participate in the study. Due to the nature of the study, study participants are not compensated or insured. As part of the blood pressure intervention, trained female community health volunteers will conduct home visits for health education and blood pressure measurement. The primary outcomes will be modeled by using multiple linear regression analysis.
This project will be an investigation of a community-based intervention to control blood pressure in countries with limited resources. The study will provide detailed information on the burden of blood pressure and also whether treatment targets are being met. Moreover, evidence will be provided on the future role of female community health volunteers for hypertension management in Nepal. The lessons learned from this study may also be replicated in other rural areas of Nepal and elsewhere in the world with similar settings.
ClinicalTrials.gov NCT02428075 . Registered on 23 April 2015.
在低收入和中等收入国家，高血压导致了心血管疾病的沉重负担；然而，由于缺乏基于人群的高血压控制方法的确凿证据，应对措施并不充分。
方法/设计：本研究的目的是确定由经过培训的女性社区健康志愿者进行的家庭健康教育和血压监测的效果。主要结局是平均收缩压的变化。将在尼泊尔莱克纳特市开展一项基于社区的、开放掩码、双臂、整群随机试验。该市分为15个行政集群。将对14个集群进行随机分组：7个为干预组，7个为对照组。参与者是从早期进行的患病率研究中招募的。根据人口比例规模，干预组929人、对照组709人将参与该研究。由于研究的性质，研究参与者不给予补偿或保险。作为血压干预的一部分，经过培训的女性社区健康志愿者将进行家访以开展健康教育和测量血压。主要结局将通过多元线性回归分析进行建模。
该项目将是对资源有限国家基于社区的血压控制干预措施的一项调查。该研究将提供有关血压负担以及治疗目标是否达成的详细信息。此外，将为尼泊尔女性社区健康志愿者在高血压管理方面的未来作用提供证据。从本研究中吸取的经验教训也可能在尼泊尔其他农村地区以及世界其他具有类似情况的地方得到推广。
ClinicalTrials.gov NCT02428075。于2015年4月23日注册。
