Community Health Worker Led Hypertension Prevention and Control
NCT ID: NCT06230835
Last Updated: 2024-01-30
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
2432 participants
INTERVENTIONAL
2024-04-30
2027-08-31
Brief Summary
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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.
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Detailed Description
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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).
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.
Aim 2 Primary outcome: Net difference in mean systolic BP (mmHg) measured after 12 months between intervention and control group.
Aim 3 Costing: Total costs of the implementation and maintenance years by summing the costs of the individual components.
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 secondary analysis will take a societal perspective.
Study Population Number of Participants Individuals with hypertension: 2432, will participate in cluster-randomized trial Community health workers: 108, will participate in focus group discussion Health workers: 84, will participate in the health worker survey Government officials: 32, will participate in key informant interview
Study setting: Investigators will include basic health facilities in Sindhupalchowk and Kavrepalanchowk districts of Bagmati province. These districts are chosen in consultation with the Province Ministry of Health (MoH) for two main reasons. First reason is the need, these are hilly districts where there are geographic challenges to deliver services through health facilities only. So, the CHW program can have the highest impact by reaching a wider community to improve HTN awareness, treatment and control. Second reason is feasibility and efficiency, these districts are the catchment areas of Dhulikhel hospital-Kathmandu University School of Medical Sciences that can directly support the program (See Letter of Support) and CHWs can refer the participants to the hospital when needed. The Provincial government has already provided permission for these health facilities to participate (See Letter of Support). In Nepal's hierarchical government structure, the provincial government commitment ensures high participation from health facilities.
Description of Intervention Local researchers will provide a 3-day training to the Community Health Workers (CHW). The CHW training will cover essential project aspects, starting with a detailed overview, including the project's introduction, aims, study area, participants, timeline, and tools. Practical sessions and role-playing exercises will be employed for the blood pressure measurement of participants, and methods for recording and reporting will be shared. The training aims to establish a foundational understanding of cardiovascular diseases, emphasizing hypertension, including its clinical features and preventive measures. The public health significance of hypertension will be underscored. The importance of diet and physical activity for the prevention of HTN will be emphasized. Specific roles and responsibilities of community health workers within the project will be highlighted. Ethical considerations, encompassing project-specific details, will be a key focus. Communication strategies for effective and culturally sensitive participant engagement will also be addressed. After receiving the training, Community Health Workers (CHW) will conduct home visits using resources from "your heart, Y: A CHW's manual for the Hispanic C" translated and adapted into Nepali and has been successfully used in the pilot Community-based intervention for blood pressure reduction in Nepal trial (COBIN) . They will visit households in their catchment area and measure BP. Each CHW will take the high BP clients (\>=140/90) to the nearest health center. They will enlist the individuals with Pre Hypertension (preHTN) (preHTN and HTN and conduct three follow-up visits to these participants, every four months. In the first visit (tentative 90 minutes), CHWs will explain the purpose of the home visit and discuss HTN and its consequences. CHWs will apply inductive questioning techniques to initiate dialogue and reflection regarding lifestyle modifications and choose lifestyle goals based on PEN protocol-2, BP monitoring, and antihypertensive medication use. In subsequent visits (approximately 60 minutes), the CHWs will measure BP and address ongoing problems. The participants and family members will be engaged in a cycle of action and reflection, discussing problems faced in achieving their goals and implementing their action plans. The discussion will be tailored to the specific needs of participants and a new action plan to support will be developed as required. These interventions are realistic and feasible to implement in Nepal.
Study Visits Individuals with hypertension: intervention arm Screening and enrollment Visit-1 (Day 1-2): A trained research assistant will contact potential participants to screen for eligibility during house-to-house visits or at health facility. In this visit, that will last about 5 minutes, the research assistant will provide the purpose of the study and screening for eligibility and if the participants are interested, will provide answers to the eligibility questions. Following this, the research assistant will obtain informed consent.
Baseline survey Visit-2 (Day 1±7): Research assistants will conduct a 45-minute interview to document their socio-demographic characteristics, diet, physical activity, smoking, and alcohol history, and clinical history. The research assistants will also measure participants' height, weight, waist circumference, and blood pressure.
Intervention to intervention arm Visit 3-5 (Day 30±14, Day 120±14, Day 240±14): The intervention arm will receive a monthly session by community health workers at their home. This will be a 60-minute session, where the CHW will provide structured counseling to the participants on their lifestyle modification goals and medications; and will measure their blood pressure will record the blood pressure in a log and provide it to the research team
Endline survey Visit 6 (Day 360±14): Trained research assistants will conduct a 30-minute interview on participants' diet, physical activity, smoking, and alcohol; and will measure height, weight, waist circumference, and blood pressure.
CHWs will receive training materials covering the basics of cardiovascular diseases and emphasizing hypertension, including its clinical features and preventive measures. The manual includes counseling methods, encompassing lifestyle modification, medication, complications of HTN, preventive measures, and risk factors of HTN. The manual also includes blood pressure measurement techniques with normal and abnormal ranges. It also includes instructions to refer participants to a health facility if their blood pressure is high, with specified cut-off values.
If any participants are found to have above 180/120 mmHg, they will be referred to their primary health care (PHC) facility. The CHW or research staff will immediately call the PHC to inform about the referral.
Control arm visit:
Screening and enrollment Visit-1 (Day 1-2): A trained research assistant will contact potential participants to screen for eligibility during house-to-house visits or at health facility. In this visit, that will last about 5 minutes, the research assistant will provide the purpose of the study and screening for eligibility and if the participants are interested, will provide answers to the eligibility questions. Following this, the research assistant will obtain informed consent.
Baseline survey Visit-2 (Day 1±7): Research assistants will conduct a 45-minute interview to document their socio-demographic characteristics, diet, physical activity, smoking, and alcohol history, and clinical history. The research assistants will also measure participants' height, weight, waist circumference, and blood pressure.
Endline survey Visit-3 (Day 360±14): Trained research assistants will conduct a 30-minute interview on participants' diet, physical activity, smoking, and alcohol; and will measure height, weight, waist circumference, and blood pressure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Intervention Group
The intervention of the study will be the Community Health Workers implementation strategy
Intervention Group
Community Health Workers (CHWs) will undergo a 4-day training program on hypertension management, including screening, counseling, medication adherence, self-care, and referrals. They will then collaborate with healthcare facilities to conduct one-day hypertension screening camps. CHWs will form self-support groups for individuals with hypertension and hold monthly meetings to discuss control strategies, review BP logs, and promote healthcare visits, including family involvement. They will also maintain regular communication with healthcare facility in-charges to ensure effective collaboration in the 'Hypertension Care Cascade Model'. No any drugs will be used in the intervention group.
Control Arm
Routine hypertension care
No interventions assigned to this group
Interventions
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Intervention Group
Community Health Workers (CHWs) will undergo a 4-day training program on hypertension management, including screening, counseling, medication adherence, self-care, and referrals. They will then collaborate with healthcare facilities to conduct one-day hypertension screening camps. CHWs will form self-support groups for individuals with hypertension and hold monthly meetings to discuss control strategies, review BP logs, and promote healthcare visits, including family involvement. They will also maintain regular communication with healthcare facility in-charges to ensure effective collaboration in the 'Hypertension Care Cascade Model'. No any drugs will be used in the intervention group.
Eligibility Criteria
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Inclusion Criteria
* have high blood pressure of 130/85 mmHg
* can provide informed consent.
Exclusion Criteria
* pregnant women due to their special health needs.
30 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Kathmandu University School of Medical Sciences
OTHER
Responsible Party
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Archana Shrestha
Associate Professor
Locations
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Archana Shrestha
Dhulikhel, Bagmati, Nepal
Countries
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Central Contacts
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Facility Contacts
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References
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Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.
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Related Links
Access external resources that provide additional context or updates about the study.
Buring J, Ridker PM. Clinical Trials in Heart Disease: A Companion to Braunwald's Heart Disease. W B Saunders Company. 2004:456.
World Health Organization, Ministry of Health and Population. Multisectoral Action Plan for the Prevention and Control of Non Communicable Diseases (2014-2020).
actors associated with Package of Essential Non-Communicable Diseases (PEN) protocol 1 Implementation in Government Health Facilities of Nepal. Nepal Health Research Council International Seminar and workshop on Public Health Action Abstract 1.3.8
Health Authorities' Perspective on Facilitators and Barriers to Implement the Package of Essential Non-communicable Disease (PEN) in Nepal: A Qualitative Study. April 2022. Eighth National Summit of Health and Population Scientists in Nepal.
Health Service Providers' Level Facilitators and Barriers in Implementing PEN Package at Primary Healthcare Level in Nepal: A Qualitative Study. April 2022. Eighth National Summit of Health and Population Scientists in Nepal. Abstract: 2.6.13
Patients' Perspective on Facilitators and Barriers to Utilize Non-Communicable Disease (NCD) Service at Primary Healthcare Level in Nepal: A Qualitative Study. April 2022. Eighth National Summit of Health and Population Scientists in Nepal.
Situational Analysis of Package of Essential Non-Communicable Disease (PEN) Implementation at Primary Health Care Setting in Nepal. April 2022. Eighth National Summit of Health and Population Scientists in Nepal.
Other Identifiers
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169421-01
Identifier Type: -
Identifier Source: org_study_id
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