NCT06258473

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

Recruiting now Phase 1 Last updated 14 February 2024

What this trial tests

Phase 1 trial testing Multicomponent decentralized care in Hypertension in 6,750 participants. Currently enrolling.

Timeline

1 January 2024

Primary endpoint
30 September 2026

30 September 2026

Quick facts

Lead sponsor	BRAC University
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	6,750
Start date	1 January 2024
Primary completion	30 September 2026
Estimated completion	30 September 2026
Sites	1 location across Bangladesh

Drugs / interventions tested

• Multicomponent decentralized care
• mHealth

Conditions studied

• Hypertension — all drugs for Hypertension →
• Diabetes — all drugs for Diabetes →

Sponsor

BRAC University

Who can join

40 and older, any sex, with Hypertension or Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Socioeconomic inequality in hypertension prevalence and care continuum: evidence from rural Bangladesh
   Xie W, Gupta A, Ahsan A, Akter F, et al · · 2026 · DOI 10.21203/rs.3.rs-8716357/v1
2. The Readiness of Primary Healthcare Facilities to Address Noncommunicable Diseases in Rural Bangladesh
   Sarker T, Xie W, Ahsan A, Atker F, et al · · 2025 · DOI 10.21203/rs.3.rs-7977902/v1
3. Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh through Digital Technology Supported Decentralized Primary Care: Protocol for a Type 2 Effectiveness- Implementation Hybrid Study
   Xie W, Ahmed S, Ahsan A, Sarker T, et al · · 2024 · DOI 10.21203/rs.3.rs-4469744/v1