A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale

被引:13
作者
Ajay, Vamadevan S. [1 ]
Tian, Maoyi [2 ]
Chen, Hao [3 ]
Wu, Yangfeng [2 ,4 ]
Li, Xian [2 ]
Dunzhu, Danzeng [5 ]
Ali, Mohammed K. [6 ]
Tandon, Nikhil [7 ]
Krishnan, Anand [8 ]
Prabhakaran, Dorairaj [1 ,9 ]
Yan, Lijing L. [2 ,10 ,11 ]
机构
[1] Publ Hlth Fdn India, CoE CARRS, Gurgaon 122002, Haryana, India
[2] Peking Univ, Hlth Sci Ctr, George Inst Global Hlth, Beijing 100088, Peoples R China
[3] Beijing Hosp, Dept Cardiol, Beijing 100730, Peoples R China
[4] Peking Univ, Hlth Sci Ctr, Dept Epidemiol & Biostat, Beijing 100088, Peoples R China
[5] Tibet Univ, Lhasa 850000, Peoples R China
[6] Emory Univ, Rollins Sch Publ Hlth, Atlanta, GA 30322 USA
[7] All India Inst Med Sci, Dept Endocrinol & Metab, New Delhi 110029, India
[8] All India Inst Med Sci, Dept Community Med, New Delhi 110029, India
[9] Ctr Chron Dis Control, New Delhi 122002, India
[10] Duke Kunshan Univ, Duke Global Hlth Inst, Kunshan 215347, Jiangsu, Peoples R China
[11] Duke Kunshan Univ, Global Heath Res Ctr, Kunshan 215347, Jiangsu, Peoples R China
基金
美国国家卫生研究院;
关键词
Cardiovascular diseases prevention and control; Research design; Developing countries; Rural population; Community health workers; Risk reduction; Electronic decision support system; BLOOD-PRESSURE; DEVELOPING-COUNTRIES; DISEASE PREVENTION; RISK-FACTORS; HEALTH; HYPERTENSION; INTERVENTIONS; GUIDELINES; REDUCTION; IMPACT;
D O I
10.1186/1471-2458-14-924
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Background: In resource-poor areas of China and India, the cardiovascular disease burden is high, but availability of and access to quality healthcare is limited. Establishing a management scheme that utilizes the local infrastructure and builds healthcare capacity is essential for cardiovascular disease prevention and management. The study aims to develop, implement, and evaluate the feasibility and effectiveness of a simplified, evidence-based cardiovascular management program delivered by community healthcare workers in resource-constrained areas in Tibet, China and Haryana, India. Methods/design: This yearlong cluster-randomized controlled trial will be conducted in 20 villages in Tibet and 20 villages in Haryana. Randomization of villages to usual care or intervention will be stratified by country. High cardiovascular disease risk individuals (aged 40 years or older, history of heart disease, stroke, diabetes, or measured systolic blood pressure of 160 mmHg or higher) will be screened at baseline. Community health workers in the intervention villages will be trained to manage and follow up high-risk patients on a monthly basis following a simplified '2 + 2' intervention model involving two lifestyle recommendations and the appropriate prescription of two medications. A customized electronic decision support system based on the intervention strategy will be developed to assist the community health workers with patient management. Baseline and follow-up surveys will be conducted in a standardized fashion in all villages. The primary outcome will be the net difference between-group in the proportion of high-risk patients taking antihypertensive medication pre- and post-intervention. Secondary outcomes will include the proportion of patients taking aspirin and changes in blood pressure. Process and economic evaluations will also be conducted. Discussion: To our knowledge, this will be the first study to evaluate the effect of a simplified management program delivered by community health workers with the help of electronic decision support system on improving the health of high cardiovascular disease risk patients. If effective, this intervention strategy can serve as a model that can be implemented, where applicable, in rural China, India, and other resource-constrained areas.
引用
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页数:8
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