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临床试验/NCT06230835
NCT06230835尚未招募不适用

Community Health Worker Led Hypertension Prevention and Control (CHPC) in Nepal: An Implementation Trial

Kathmandu University School of Medical Sciences2 个研究点 分布在 1 个国家目标入组 2,432 人开始时间: 2024年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,432
试验地点
2
主要终点
Cost-effectiveness

研究概览

简要总结

With its high prevalence and concomitant increased risk of cardiovascular disease (CVD), hypertension (HTN) is a major global public health challenge. About 13.5% of premature deaths, 54% of incident stroke and 47% of incident coronary heart disease (CHD) worldwide are attributed to high blood pressure (BP). In Nepal, the prevalence of HTN among adults is 25% is similar to the global prevalence. In Nepal, however, a comparatively larger proportion of adults (44%) are unaware of their HTN status, 33% of HTN patients are receiving treatment, and only 12% of the patients have their BP under control. There are proven evidence-based interventions that have been recommended for the prevention and control of HTN including weight loss; healthy diet incorporating reduced sodium, increased fruits and vegetables, and reduced saturated fats; increased physical activity; lowered alcohol; and anti-HTN medications. Despite the availability of these proven effective lifestyle changes and low-cost anti-HTN treatment in preventing major vascular events and total mortality, these recommendations have not been translated into practice to improve population health.

In Nepal, the Package of Essential Non Communicable Diseases (PEN) Implementation Plan (2016-2020) was adopted in line with the Multi-sectoral Action Plan for the prevention and control of non communicable diseases (NCD). The PEN includes protocols to detect and manage HTN at the basic health facilities that provide primary health care incorporating all of the above-mentioned evidence-based interventions. However, our just-concluded study to evaluate the implementation of PEN in Nepal (1R21TW011718-01) demonstrated major implementation barriers at multiple levels that cannot be addressed by just health facility-based PEN: (a) Individual level: b) Interpersonal level (c) Community level (d) Organizational level.

In response to these multi-level implementation barriers, investigators propose to implement and evaluate a new task-shifting strategy to community health workers (CHW), leading to improved HTN prevention and control. Task-shifting has been proposed as a potential solution to not only address an overburdened health care system but also as a viable method for implementing primary and secondary prevention at the community-level. There is growing evidence that HTN patients can be cared for by CHW in other settings.

详细描述

Study Design Investigators will conduct a Hybrid type III effectiveness-implementation design focusing primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to uptake or fidelity of the intervention.38 The primary implementation outcomes (aim 1) - reach, adoption, implementation and maintenance - are selected to answer the central research question of this study. Investigators will assess these outcomes in the intervention group using data from the process evaluation in intervention health facilities. To measure the effectiveness (aim2), Investigators will use a cluster-randomized design to assess effectiveness in decreasing mean systolic BP in the intervention group compared to the control group at 12 months after the intervention. Investigators will also measure cost and estimate incremental cost per participant with awareness on and control of high BP(aim 3).

Outcome Variables

Aim 1 Reach: Percentage of CHWs implementing the program will participate in at least 8 of the12 monthly meetings; Percentage of the hypertensive patients in the community are aware of their high BP status.

Adoption: Percentage of the health facilities asked to participate in adopting the program. Adoption will be a dichotomous measure --(adopted/no adopted). HF will be coded as adopting the program in CHWs completes the initial CHW training session.

Program implementation: A percentage of the health facility will implement a minimum standard to program implementation. Implementation will be a dichotomous measure (successful vs inadequate).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 years or older
  • have high blood pressure of 130/85 mmHg
  • can provide informed consent.

排除标准

  • severe illness requiring bed rest,
  • pregnant women due to their special health needs.

结局指标

主要结局

Cost-effectiveness

时间窗: 1 year

Investigators will estimate the cost-effectiveness in terms of incremental cost per HTN awareness, and incremental cost per BP controlled client. The primary analysis will take a financial perspective and the secondary analysis will take a societal perspective.

Reach

时间窗: 1 year

Percentage of CHWs implementing the program will participate in at least 8 of the12 monthly meetings; Percentage of the hypertensive patients in the community are aware of their high BP status.

Adoption

时间窗: 1 year

Percentage of the health facilities asked to participate in adopting the program. Adoption will be a dichotomous measure --(adopted/no adopted). Health facility (HF) will be coded as adopting the program in CHWs completes the initial CHW training session.

Program Implementation

时间窗: 1 year

A of the health facility will implement a minimum standard to program implementation. Implementation will be a dichotomous measure (successful v inadequate).

Differences in in mean systolic blood pressure

时间窗: 1 year

Net difference in mean systolic BP (mmHg) measured after 12 months between intervention and control group.

Difference in Body Mass Index (BMI)

时间窗: 1 year

The net difference in mean BMI was measured after 12 months between the intervention and control group. BMI will be calculated as weight in kilograms divided by hight in meters square.

Costing

时间窗: 1 year

Total costs of the implementation and maintenance years by summing the costs of the individual components.

Maintenance:

时间窗: 1 year

Percentage of the health facility that will implement a minimum standard to program implementation during the maintenance period. As secondary outcomes, investigators will assess the extent to which each of the individual core components were maintained, and examine the percent of health facilities implementing all core components.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Archana Shrestha

Associate Professor

Kathmandu University School of Medical Sciences

研究点 (2)

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