Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh Through mHealth and Decentralized Primary Care: The Dinajpur Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6,750
- 试验地点
- 2
- 主要终点
- Hypertension and Diabetes control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants aged 40 or above
- •With hypertension and diabetes
- •Residents of specific study areas
- •Willing to participate
排除标准
- •Adults aged less than 40 years
- •Pregnant women
- •Severely ill
- •Having severe disabilities both physical and mental)
结局指标
主要结局
Hypertension and Diabetes control
时间窗: 2 years and 9 months
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.
次要结局
- Hypertension and diabetes care cascade(2 years and 9 months)
