NCT06258473 Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh: The Dinajpur Study
| NCT ID | NCT06258473 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | BRAC University |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,750 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6,750 participants in total. It began in 2024-01-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Malay K Mridha, PhD
PRINCIPAL INVESTIGATOR
BRAC University - School of Public Health
Frequently Asked Questions
Who can join the NCT06258473 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06258473 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06258473 currently recruiting?
Yes, NCT06258473 is actively recruiting participants. Contact the research team at malay.mridha@bracu.ac.bd for enrollment information.
Where is the NCT06258473 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT06258473 clinical trial?
NCT06258473 is sponsored by BRAC University. The principal investigator is Malay K Mridha, PhD at BRAC University - School of Public Health. The trial plans to enroll 6,750 participants.