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

NCT06258473 | Recruiting Phase 1 DMC

• 1 other identifier: IRB-16 November-23-041
• Study Type: interventional
• Target: 6,750
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hypertension; Diabetes

Keywords

Hypertension; Diabetes; Care continumm; mHealth; Decentralized Primary Care; Rural Bangladesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hypertension and diabetes care cascade

  2 years and 9 months

Study Arms (3)

Multicomponent decentralized care

EXPERIMENTAL

mHealth plus decentralized primary care The multi-component intervention aims 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

Combination Product: Multicomponent decentralized care; Combination Product: mHealth

mHealth

ACTIVE COMPARATOR

In subdistrict with mHealth intervention only, we will provide the same training on hypertension and diabetes care to physicians and nurses at NCD corner in UHC, and training to use Simple App for hypertension and diabetes management. Quarterly supervision by higher-level health administrators and medical professionals to NCD corner helps solve issues with patient management, medication supply, etc. Visits may be informed by a performance summary made available by the Simple App dashboard. Two supportive visits by the study team will be organized to help NCD Corner solve technical issues with Simple App. 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.

Combination Product: mHealth

Usual care

NO INTERVENTION

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.

Interventions

Multicomponent decentralized care COMBINATION_PRODUCT

1. 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 2. 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 3. CHWs assist in screening, counselling, referral, and follow-up for CHW at village level

Multicomponent decentralized care

mHealth COMBINATION_PRODUCT

Training and support on Simple app for HTN/DM patient management \& training NCD corner clinicians on clinical guidelines of Upazila Health complex

Multicomponent decentralized care; mHealth

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants aged 40 or above
• With hypertension and diabetes
• Residents of specific study areas
• Willing to participate

You may not qualify if:

• Adults aged less than 40 years
• Children
• Pregnant women
• Severely ill
• Having severe disabilities both physical and mental)

Sponsors & Collaborators

• BRAC University: lead
• Imperial College London: collaborator
• Nanyang Technological University: collaborator

Study Sites (1)

BRAC James P Grant School of Public Health

Dhaka, 1213, Bangladesh

RECRUITING

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MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Malay K Mridha, PhD

  BRAC University - School of Public Health

  PRINCIPAL INVESTIGATOR

• John C Chambers, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malay K Mridha, PhD

CONTACT

+8801715190573; malay.mridha@bracu.ac.bd

Wubin Xie, DrPH

CONTACT

wubin.xie@ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)