Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh: The Dinajpur Study

Hypertension Clinical Trial

Official title:

Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh Through mHealth and Decentralized Primary Care: The Dinajpur Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258473
• Other study ID #: IRB-16 November-23-041
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: BRAC University
• Contact: Malay K Mridha, PhD
• Phone: +8801715190573
• Email: malay.mridha[@]bracu.ac.bd
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 barriers/facilitators 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 (i.e., smoking, dietary salt intake, physical activity, alcohol consumption), and burden for patients (e.g., 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.

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 1.13 billion in 2015, largely due to increases in low- and middle-income countries (LMICs).3 Globally, 10.5% 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 (i.e., screening, diagnosis, treatment, control) are complex and multifactorial, reflecting the vulnerabilities at individual, community, and healthcare system levels in LMICs.Few 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 HIV/AIDS 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 27.4% of Bangladeshi adults have hypertension and 9.8% have diabetes. According to 2017-2018 Bangladesh Demographic and Health Survey, only 36.7% of Bangladeshi adults with hypertension were aware that they had hypertension, and only 31.1% were on treatment and 12.7% had blood pressure controlled. The awareness, treatment, and control rates for diabetes were estimated to be 30.9%, 28.2%, and 26.5%, respectively. Tobacco use, insufficient fruit/vegetable intake, overweight/obese, 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 strategies.41 A three-arm mixed-methods quasi-experimental design will be used to achieve the aims specified before. Two intervention subdistricts (i.e., 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 barriers/facilitators 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 (i.e., smoking, dietary salt intake, physical activity, alcohol consumption), burden for patients (e.g., 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 (sub)centers, 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 distance.42 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 government's 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 https://www.simple.org). 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 government's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6750
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• All participants aged 40 or above

• With hypertension and diabetes

• Residents of specific study areas

• Willing to participate

Exclusion Criteria:

• Adults aged less than 40 years

• Children

• Pregnant women

• Severely ill

• Having severe disabilities both physical and mental)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Hypertension

Intervention

Combination Product:
• Multicomponent decentralized care
Training and support on Simple app for HTN/DM management & training NCD corner clinicians on clinical guidelines and establish team-based care for Upazila level NCD corner CHCPs conduct BP/BG screening, monitoring, lifestyle counseling, dispensing of medications, follow-up overdue patients at CCs & CHCP care coordination supported by Simple app at community clinics CHWs assist in screening, counselling, referral, and follow-up for CHW at village level
• mHealth
Training and support on Simple app for HTN/DM patient management & training NCD corner clinicians on clinical guidelines of Upazila Health complex

Locations

Country	Name	City	State
Bangladesh	BRAC James P Grant School of Public Health	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
BRAC University	Imperial College London, Nanyang Technological University

Country where clinical trial is conducted

Bangladesh, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypertension and Diabetes control	The primary outcome will be the proportion of patients treated for NCDs who achieved or maintained disease-specific controlled status, according to national or WHO PEN protocols. Hypertension is considered controlled if SBP<140 mmHg and DBP<90 mmHg for most patients, and if SBP<130 mmHg and DBP<80 mmHg for patients who have comorbidities (diabetes, heart disease, stroke, chronic kidney disease) or having 10-year CVD risk = 30%. Goal for glycemic control is fasting plasma glucose 4.4-7.2 mmol/L, or random plasma glucose <11.1 mmol/L. The effectiveness will be assessed primarily using repeated independent community-based surveys.	2 years and 9 months
Secondary	Hypertension and diabetes care cascade	Secondary outcomes include hypertension and diabetes care cascade (i.e. % of patients aware of their condition, % of diagnosed patients on treatment), smoking cessation among HTN/DM patients, and meeting recommended physical activity level.	2 years and 9 months