Hypertension Clinical Trial
— CHPCOfficial title:
Community Health Worker Led Hypertension Prevention and Control (CHPC) in Nepal: An Implementation Trial
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.
Status | Not yet recruiting |
Enrollment | 2432 |
Est. completion date | August 2027 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion Criteria: - 30 years or older - have high blood pressure of 130/85 mmHg - can provide informed consent. Exclusion Criteria: - severe illness requiring bed rest, - pregnant women due to their special health needs. |
Country | Name | City | State |
---|---|---|---|
Nepal | Archana Shrestha | Dhulikhel | Bagmati |
Lead Sponsor | Collaborator |
---|---|
Kathmandu University School of Medical Sciences | National Heart, Lung, and Blood Institute (NHLBI) |
Nepal,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year | |
Primary | Adoption | 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. | 1 year | |
Primary | Program Implementation | A of the health facility will implement a minimum standard to program implementation. Implementation will be a dichotomous measure (successful v inadequate). | 1 year | |
Primary | Maintenance: | 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. | 1 year | |
Primary | Differences in in mean systolic blood pressure | Net difference in mean systolic BP (mmHg) measured after 12 months between intervention and control group. | 1 year | |
Primary | Costing | Total costs of the implementation and maintenance years by summing the costs of the individual components. | 1 year | |
Primary | Cost-effectiveness | 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. | 1 year | |
Primary | Difference in Body Mass Index (BMI) | 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. | 1 year |
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