The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.

The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.
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DOI:
10.1186/1745-6215-15-435
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发表时间:
2014-11-07
期刊:
影响因子:
2.5
通讯作者:
Twine R
Twine R
中科院分区:
医学4区
文献类型:
--
作者:
Thorogood M;Goudge J;Bertram M;Chirwa T;Eldridge S;Gómez-Olivé FX;Limbani F;Musenge E;Myakayaka N;Tollman S;Twine R

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南非的高血压患病率很高,而且还在上升。许多受影响的人没有使用药物,很少有人控制血压。直到最近,初级保健诊所的重点是妇幼保健和急性病的管理,但政府的新举措已将重点转向慢性病,包括艾滋病毒/艾滋病和高血压。Nkateko试验将测试基于诊所的非专业卫生工作者(LHWs)在支持高血压管理方面的有效性。这是一项基于南非东北部Agincourt分区的实用的群集随机对照试验,并以长期健康和人口监测为基础。八个初级保健设施,与他们的集水社区,被随机分配到常规护理或增加LHWs专注于慢性病护理。将为所有诊所(干预和对照)提供一名职员,以收集诊所就诊者的信息,并将其与先前存在的监测记录进行匹配。干预诊所将有LHWs与护理人员一起工作,重点关注慢性病患者的医疗保健,特别是高血压患者。LHWs将得到一名实施经理的支持,该经理将与诊所工作人员合作,为LHWs发挥最有效的作用。控制诊所将继续提供常规护理。主要结局将是干预前后进行的两次人群调查之间的变化,即高血压不受控制的人群比例和风险特征表明至少有中度心血管疾病风险。过程评价将基于现实主义方法,使用患者离职面谈、诊所观察和与卫生专业人员、LHWs和患者的面谈,以记录干预措施及其实施情况。这项试验的设计存在挑战。通过人口调查评估变化可能会减少可衡量的影响;然而,我们认为这是适当的,因为我们的目标是吸引那些目前不使用诊所的人,我们希望改善对诊所使用者的护理。诊所是在一次公开会议上随机化的,因为我们担心远程随机化过程不会得到社区的信任。我们一直在努力实现干预和过程评估之间的有效平衡。ISRCTN 12128227(2014年3月5日注册)本文的在线版本(doi:10.1186/1745-6215-15-435)包含补充材料,可供授权用户使用。
South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension. The Nkateko trial will test the effectiveness of clinic-based lay health workers (LHWs) in supporting hypertension management. It is a pragmatic, cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa, and it is underpinned by long-term health and demographic surveillance. Eight primary care facilities, with their catchment communities, are randomised to usual care or the addition of LHWs focused on chronic care. All clinics (intervention and control) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records. Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions, particularly hypertension. The LHWs will be supported by an implementation manager, who will work with clinic staff to develop the most effective role for the LHWs. Control clinics will continue to provide usual care. The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease. A process evaluation will be based on a realist approach using patient exit interviews, clinic observations and interviews with health professionals, LHWs and patients to document the intervention and its implementation. There are challenges in the design of this trial. Assessing change through population surveys may reduce measurable effects; however, we feel this is appropriate because we aim to attract those who currently do not use clinics, and we hope to improve care for clinic users. Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community. We are constantly working to achieve an effective balance between the intervention and process evaluations. ISRCTN12128227 (registered 5 March 2014) The online version of this article (doi:10.1186/1745-6215-15-435) contains supplementary material, which is available to authorized users.
DOI: 10.1093/heapol/czn006
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