Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258473
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-02-06
Brief Title:
Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh The Dinajpur Study
Sponsor:
BRAC University
Organization:
BRAC University
Study Overview
Official Title:
Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh Through mHealth and Decentralized Primary Care The Dinajpur Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
In the present implementation study we aim to document the experience of implementing integrated decentralized primary care in rural Bangladesh including components of healthcare provider training mHealth decentralization with task shifting and community-based care and to generate data on the effectiveness and cost-effectiveness of the multicomponent integrated care as compared to usual care and to mHealth intervention alone We will also Investigate the factors that explain how the interventions influence hypertension and diabetes management and explore barriersfacilitators to delivering and sustaining intervention We will conduct mixed-methods research to understand how the intervention influences treatment and prevention in this patient population Particularly we will assess lifestyle changes ie smoking dietary salt intake physical activity alcohol consumption and burden for patients eg waiting time travel-related cost at individual and community level Qualitative data will shed light on facilitators and barriers to hypertension and diabetes prevention and control from the perspectives of patients and their families primary care providers public health officials and other stakeholders Additionally we will undertake a health economic evaluation of the interventions for primary care systems A comprehensive evaluation of cost and effectiveness will be important for the models tested providing necessary evidence for policymakers and stakeholders to scale up the interventions We hypothesize that compared with usual care the multicomponent decentralized primary care will improve all steps along hypertension and diabetes care continuum On the other hand we hypothesize that the mHealth intervention alone Simple App may improve BP and glycemic control compared with usual care but will have a limited impact on rates of screening diagnosis and treatment We also hypothesize that the multicomponent integrated care will lead to a higher treatment success rate relative to mHealth intervention alone
Detailed Description:
Background
Hypertension is the predominant risk factor for cardiovascular diseases CVDs - the leading cause of death worldwide In 2015 1 in 5 adult women and close to 1 in 4 adult men had elevated blood pressure The estimated number of adults with elevated blood pressure increased from 594 million in 1975 to 113 billion in 2015 largely due to increases in low- and middle-income countries LMICs3 Globally 105 adult population has diabetes with almost half unaware of the condition they are living with Complications of persistently elevated blood pressure and poor glycemic control such as heart disease stroke chronic kidney disease blindness are well documented Compared with patients with controlled blood pressure hypertension patients without treatment and those treated but with uncontrolled blood pressure have substantially higher risk of all-cause and CVD mortality The factors underlying the gaps in hypertension and diabetes care continuum ie screening diagnosis treatment control are complex and multifactorial reflecting the vulnerabilities at individual community and healthcare system levels in LMICsFew studies have examined the strategy to address shortage of healthcare human resources and NCD care accessibility through decentralization with task shifting or task sharing which has been shown a viable strategy to rapidly scale-up antiretroviral therapy for HIVAIDS care in resource-limited settings Like many other LMICs Bangladesh is experiencing rapid demographic and epidemiologic transitions In the recent years NCD replaced infectious disease and maternal and neonatal conditions as the leading cause of death accounting for 71 of all deaths in Bangladesh An estimated 274 of Bangladeshi adults have hypertension and 98 have diabetes According to 2017-2018 Bangladesh Demographic and Health Survey only 367 of Bangladeshi adults with hypertension were aware that they had hypertension and only 311 were on treatment and 127 had blood pressure controlled The awareness treatment and control rates for diabetes were estimated to be 309 282 and 265 respectively Tobacco use insufficient fruitvegetable intake overweightobese are highly prevalent Over the past decade the Government of Bangladesh has promoted improved NCD care through national multisectoral actions most notably through the establishment of dedicated noncommunicable disease facilities NCD Corners at subdistrict hospitals since 2011 These NCD Corners were designed to provide preventive and clinical care for common NCDs Despite the initiative NCD corners remained nascent due to a lack of specific guidelines trained workforce appropriate medicines and supplies adequate laboratory facilities and poor record-keeping and reporting
In the present study we aim to document the experience of implementing a multicomponent decentralized primary care in rural Bangladesh including components of healthcare provider training mHealth decentralization with task shifting and community-based care and to generate data on the effectiveness and cost-effectiveness of the multicomponent integrated care as compared to usual care and to mHealth intervention alone
Study design
This is a type 2 effectiveness-implementation hybrid study with a dual focus on testing of effectiveness of interventions and implementation strategies41 A three-arm mixed-methods quasi-experimental design will be used to achieve the aims specified before Two intervention subdistricts ie mHealth only and mHealth plus task sharing decentralization and community-based care and one reference subdistrict from Dinajpur district Rangpur division in Northern Bangladesh Figure 1 will be selected to implement the study While the key outcomes will be evaluated with community-based repeated cross-sectional surveys with independent samples we will also make use of facility-based prospective cohort data to supplement community-based surveys We will employ a mixed methods approach to generate rich data on changes in primary and secondary outcomes and quantitative and qualitative data for process evaluation The project duration is 36 months
Specific objectives and hypothesis of the study
SA1 Document the experience of implementing a multicomponent decentralized care in public primary care system for hypertension and diabetes and evaluate the effectiveness of the package compared with usual care and mHealth intervention alone The findings will not only shed light on the effectiveness of the interventions on treatment outcomes but will also informing approaches to improve screening diagnosis and management of these conditions Among the first we expect to provide data on the role of decentralization for expanding NCD care in resource limited settings
SA2 Investigate the factors that explain how the interventions influences hypertension and diabetes management and explore barriersfacilitators to deliver and sustaining intervention We will conduct mixed methods research to understand how the intervention influences treatment and prevention in this patient population Particularly we will assess changes in lifestyle ie smoking dietary salt intake physical activity alcohol consumption burden for patients eg waiting time travel-related cost at individual and community level Qualitative data will shed light on facilitators and barriers to hypertension and diabetes prevention and control from perspectives of patients and their families primary care providers and public health officials and other stakeholders
SA3 Undertake a health economic evaluation of the interventions for primary care systems A comprehensive evaluation of cost and effectiveness will be important for the models tested providing necessary evidence for policy makes and stakeholders to scale up the interventions
We hypothesize that compared with usual care the multicomponent decentralized primary care will improve all steps along the hypertension and diabetes care continuum On the other hand we hypothesize that the mHealth intervention alone Simple App may improve BP and glycemic control compared with usual care but will have limited impact on rates of screening diagnosis and treatment We also hypothesize that the multicomponent integrated care will lead to higher treatment success rate relative to mHealth intervention alone
Study population and settings
In rural Bangladesh a subdistrict Upazila is the second lowest tier of administration while union is the lowest rural administrative unit and each union is made up of nine wards usually one village is designated as a ward The primary healthcare system in rural areas consist of a subdistrict level hospital Upazila Health Complexes union health subcenters and community clinics which cover 2 to 4 villages A Upazila Health Complex lies at the top of the primary care system It is typically a 50-bed hospital serving a population of a few hundred thousand
Community clinics are at the lowest level of the healthcare facility hierarchy With two rooms and drinking-water and lavatory facilities under a covered waiting area community clinics were designed to be accessible for more than 80 of rural population within less than 30-minute walking distance42 Community clinics are staffed by a Community Health Care Provider CHCP who usually receive 4-month medical training
Interventions
Built upon assessment of barriers to hypertension and diabetes management at patient provider and health system levels and previous interventional studies a multicomponent intervention package was designed to increase access to primary care and to improve care quality and patient retention The intervention package includes mHealth decentralization with task sharing community-based care and supportive monitoring visits The effectiveness of the intervention package is compared with mHealth only intervention and usual care
Description of the interventions Multicomponent decentralized care
It will include both government model and mHealth for patient management and some other components like supportive supervisions In line with Bangladesh governments recommendation Simple App will be used by primary care facilities for coordinated NCD management The Simple App was developed and is actively maintained by Resolve to Save Lives more details about the app can be found from the website httpswwwsimpleorg The app was designed to tackle two major factors contribute to blood pressure and glycemic control among treated patients with hypertension and diabetes namely timely titration and adherence with therapy To accommodate the context of busy primary care facilities data collection is limited to a few key variables such as prescription follow-up visit and changes in blood pressure and blood glucose Using unique patient ID the app allows seamless transferring of electronic health records among primary care facilities and thus ensure continuity of the process
Engaging community health workers in NCD care Integrating hypertension and diabetes care into the community by training CHWs to provide screening counselling and follow-up has been shown to improve hypertension and diabetes care management in many LMICs including countries from South Asia In line with previous studies we will enlist CHWs in case finding counselling referral and follow-up Existing CHWs will be trained and provided with necessary equipment and health education materials and tools to carry out these tasks Initial training will cover topics including basics of hypertension and diabetes lifestyle risk factors counselling patient self-management and collaboration with CHCPs A refresher training will be done at 6 months of implementation CHWs will not be compensated for the activities performed to be consistent with Bangladesh governments plan considering scalability
Supportive monitoring and supervision Quarterly supervision by higher level health administrators and medical professionals will be organized to NCD corner to help solve issues with patient managements medication supply etc Visits may be informed by performance summary made available by Simple App dashboard Similarly quarterly supervision to CCs by NCD corner medical staff and subdistrict health officials will be done Supportive visits by study team will be organized to help NCD corners and CCs solve technical issues with Simple App
mHealth only
In subdistrict with mHealth intervention only training and support to use Simple App for hypertension and diabetes management will be provided The healthcare providers at NCD corner will decide how they react to the information made available by the digital tool and similarly the patient component will not be included Patient pathways remain the same as usual care
Usual care
Existing usual care provided by government primary care system including screening treatment initiating drug refill and routine follow-up at subdistrict NCD corner Community clinics and CHWs have less involvement in NCD care provision
Hypertension is the predominant risk factor for cardiovascular diseases CVDs - the leading cause of death worldwide In 2015 1 in 5 adult women and close to 1 in 4 adult men had elevated blood pressure The estimated number of adults with elevated blood pressure increased from 594 million in 1975 to 113 billion in 2015 largely due to increases in low- and middle-income countries LMICs3 Globally 105 adult population has diabetes with almost half unaware of the condition they are living with Complications of persistently elevated blood pressure and poor glycemic control such as heart disease stroke chronic kidney disease blindness are well documented Compared with patients with controlled blood pressure hypertension patients without treatment and those treated but with uncontrolled blood pressure have substantially higher risk of all-cause and CVD mortality The factors underlying the gaps in hypertension and diabetes care continuum ie screening diagnosis treatment control are complex and multifactorial reflecting the vulnerabilities at individual community and healthcare system levels in LMICsFew studies have examined the strategy to address shortage of healthcare human resources and NCD care accessibility through decentralization with task shifting or task sharing which has been shown a viable strategy to rapidly scale-up antiretroviral therapy for HIVAIDS care in resource-limited settings Like many other LMICs Bangladesh is experiencing rapid demographic and epidemiologic transitions In the recent years NCD replaced infectious disease and maternal and neonatal conditions as the leading cause of death accounting for 71 of all deaths in Bangladesh An estimated 274 of Bangladeshi adults have hypertension and 98 have diabetes According to 2017-2018 Bangladesh Demographic and Health Survey only 367 of Bangladeshi adults with hypertension were aware that they had hypertension and only 311 were on treatment and 127 had blood pressure controlled The awareness treatment and control rates for diabetes were estimated to be 309 282 and 265 respectively Tobacco use insufficient fruitvegetable intake overweightobese are highly prevalent Over the past decade the Government of Bangladesh has promoted improved NCD care through national multisectoral actions most notably through the establishment of dedicated noncommunicable disease facilities NCD Corners at subdistrict hospitals since 2011 These NCD Corners were designed to provide preventive and clinical care for common NCDs Despite the initiative NCD corners remained nascent due to a lack of specific guidelines trained workforce appropriate medicines and supplies adequate laboratory facilities and poor record-keeping and reporting
In the present study we aim to document the experience of implementing a multicomponent decentralized primary care in rural Bangladesh including components of healthcare provider training mHealth decentralization with task shifting and community-based care and to generate data on the effectiveness and cost-effectiveness of the multicomponent integrated care as compared to usual care and to mHealth intervention alone
Study design
This is a type 2 effectiveness-implementation hybrid study with a dual focus on testing of effectiveness of interventions and implementation strategies41 A three-arm mixed-methods quasi-experimental design will be used to achieve the aims specified before Two intervention subdistricts ie mHealth only and mHealth plus task sharing decentralization and community-based care and one reference subdistrict from Dinajpur district Rangpur division in Northern Bangladesh Figure 1 will be selected to implement the study While the key outcomes will be evaluated with community-based repeated cross-sectional surveys with independent samples we will also make use of facility-based prospective cohort data to supplement community-based surveys We will employ a mixed methods approach to generate rich data on changes in primary and secondary outcomes and quantitative and qualitative data for process evaluation The project duration is 36 months
Specific objectives and hypothesis of the study
SA1 Document the experience of implementing a multicomponent decentralized care in public primary care system for hypertension and diabetes and evaluate the effectiveness of the package compared with usual care and mHealth intervention alone The findings will not only shed light on the effectiveness of the interventions on treatment outcomes but will also informing approaches to improve screening diagnosis and management of these conditions Among the first we expect to provide data on the role of decentralization for expanding NCD care in resource limited settings
SA2 Investigate the factors that explain how the interventions influences hypertension and diabetes management and explore barriersfacilitators to deliver and sustaining intervention We will conduct mixed methods research to understand how the intervention influences treatment and prevention in this patient population Particularly we will assess changes in lifestyle ie smoking dietary salt intake physical activity alcohol consumption burden for patients eg waiting time travel-related cost at individual and community level Qualitative data will shed light on facilitators and barriers to hypertension and diabetes prevention and control from perspectives of patients and their families primary care providers and public health officials and other stakeholders
SA3 Undertake a health economic evaluation of the interventions for primary care systems A comprehensive evaluation of cost and effectiveness will be important for the models tested providing necessary evidence for policy makes and stakeholders to scale up the interventions
We hypothesize that compared with usual care the multicomponent decentralized primary care will improve all steps along the hypertension and diabetes care continuum On the other hand we hypothesize that the mHealth intervention alone Simple App may improve BP and glycemic control compared with usual care but will have limited impact on rates of screening diagnosis and treatment We also hypothesize that the multicomponent integrated care will lead to higher treatment success rate relative to mHealth intervention alone
Study population and settings
In rural Bangladesh a subdistrict Upazila is the second lowest tier of administration while union is the lowest rural administrative unit and each union is made up of nine wards usually one village is designated as a ward The primary healthcare system in rural areas consist of a subdistrict level hospital Upazila Health Complexes union health subcenters and community clinics which cover 2 to 4 villages A Upazila Health Complex lies at the top of the primary care system It is typically a 50-bed hospital serving a population of a few hundred thousand
Community clinics are at the lowest level of the healthcare facility hierarchy With two rooms and drinking-water and lavatory facilities under a covered waiting area community clinics were designed to be accessible for more than 80 of rural population within less than 30-minute walking distance42 Community clinics are staffed by a Community Health Care Provider CHCP who usually receive 4-month medical training
Interventions
Built upon assessment of barriers to hypertension and diabetes management at patient provider and health system levels and previous interventional studies a multicomponent intervention package was designed to increase access to primary care and to improve care quality and patient retention The intervention package includes mHealth decentralization with task sharing community-based care and supportive monitoring visits The effectiveness of the intervention package is compared with mHealth only intervention and usual care
Description of the interventions Multicomponent decentralized care
It will include both government model and mHealth for patient management and some other components like supportive supervisions In line with Bangladesh governments recommendation Simple App will be used by primary care facilities for coordinated NCD management The Simple App was developed and is actively maintained by Resolve to Save Lives more details about the app can be found from the website httpswwwsimpleorg The app was designed to tackle two major factors contribute to blood pressure and glycemic control among treated patients with hypertension and diabetes namely timely titration and adherence with therapy To accommodate the context of busy primary care facilities data collection is limited to a few key variables such as prescription follow-up visit and changes in blood pressure and blood glucose Using unique patient ID the app allows seamless transferring of electronic health records among primary care facilities and thus ensure continuity of the process
Engaging community health workers in NCD care Integrating hypertension and diabetes care into the community by training CHWs to provide screening counselling and follow-up has been shown to improve hypertension and diabetes care management in many LMICs including countries from South Asia In line with previous studies we will enlist CHWs in case finding counselling referral and follow-up Existing CHWs will be trained and provided with necessary equipment and health education materials and tools to carry out these tasks Initial training will cover topics including basics of hypertension and diabetes lifestyle risk factors counselling patient self-management and collaboration with CHCPs A refresher training will be done at 6 months of implementation CHWs will not be compensated for the activities performed to be consistent with Bangladesh governments plan considering scalability
Supportive monitoring and supervision Quarterly supervision by higher level health administrators and medical professionals will be organized to NCD corner to help solve issues with patient managements medication supply etc Visits may be informed by performance summary made available by Simple App dashboard Similarly quarterly supervision to CCs by NCD corner medical staff and subdistrict health officials will be done Supportive visits by study team will be organized to help NCD corners and CCs solve technical issues with Simple App
mHealth only
In subdistrict with mHealth intervention only training and support to use Simple App for hypertension and diabetes management will be provided The healthcare providers at NCD corner will decide how they react to the information made available by the digital tool and similarly the patient component will not be included Patient pathways remain the same as usual care
Usual care
Existing usual care provided by government primary care system including screening treatment initiating drug refill and routine follow-up at subdistrict NCD corner Community clinics and CHWs have less involvement in NCD care provision
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