Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-11
Brief Title:
Community Health Worker Led Hypertension Prevention and Control
Sponsor:
Kathmandu University School of Medical Sciences
Organization:
Kathmandu University School of Medical Sciences
Study Overview
Official Title:
Community Health Worker Led Hypertension Prevention and Control CHPC in Nepal An Implementation Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHPC
Brief Summary:
With its high prevalence and concomitant increased risk of cardiovascular disease CVD hypertension HTN is a major global public health challenge About 135 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
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
Detailed Description:
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 intervention38 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 BPaim 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 --adoptedno 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 Nepals 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 projects 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 CHWs 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 14090 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 17 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 3014 Day 12014 Day 24014 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 36014 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 180120 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 17 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 36014 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
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 --adoptedno 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 Nepals 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 projects 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 CHWs 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 14090 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 17 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 3014 Day 12014 Day 24014 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 36014 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 180120 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 17 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 36014 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL169421-01 | NIH | None | httpsreporternihgovquickSearch1R01HL169421-01 |