An interventional study of Intervention Group in Hypertension, sponsored by Kathmandu University School of Medical Sciences. Not yet recruiting at 1 site in Nepal. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Kathmandu University School of Medical Sciences · Not applicable, Interventional, and Prevention
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.
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).
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 2,432 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Kathmandu University School of Medical Sciences is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention of the study will be the Community Health Workers implementation strategy
Behavioral: Intervention Group
Routine hypertension care
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.
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.
Time frame: 1 year
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.
Time frame: 1 year
Program Implementation
A of the health facility will implement a minimum standard to program implementation. Implementation will be a dichotomous measure (successful v inadequate).
Time frame: 1 year
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.
Time frame: 1 year
Differences in in mean systolic blood pressure
Net difference in mean systolic BP (mmHg) measured after 12 months between intervention and control group.
Time frame: 1 year
Costing
Total costs of the implementation and maintenance years by summing the costs of the individual components.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: No
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Kathmandu University School of Medical Sciences