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Hypertension Home Monitoring With Community Health Workers
- BDCTR ID
- BDCTR-2026-000091
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Shahin Alam (Responsible Party)
- Last Update Posted
- 2026-08-10
Active, not recruiting
No longer looking for participants
Study Record Versions
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| Select | Version | Date submitted (YYYY-MM-DD) | Changes |
|---|---|---|---|
| 1 | 2026-08-10Current |
|
Select two versions to compare.
Viewing V1 (2026-08-10)
Study Details
Study Identification
| Unique Protocol ID | BMU-MED-2026-009 |
|---|---|
| Brief Title | Hypertension Home Monitoring With Community Health Workers |
| Official Title | Home Blood-pressure Monitoring Supported by Community Health Workers Versus Clinic-only Care for Hypertension |
| Secondary IDs |
Study Status
| Record Verification | 2026-08 |
|---|---|
| Overall Status | Active, not recruiting |
| Study Start | 2026-06-22 |
| Primary Completion | 2027-03-31 |
| Study Completion | 2027-06-30 |
| First Submitted | |
| First Submitted that Met QC Criteria | 2026-06-22 |
| First Posted | 2026-06-22 [Actual] |
| Last Update Submitted that Met QC Criteria | 2026-08-10 |
| Last Update Posted | 2026-08-10 [Actual] |
Sponsor/Collaborators
| Sponsor | Bangladesh Medical University |
|---|---|
| Responsible Party | Dr Shahin Alam |
| Collaborators |
Oversight
| U.S. FDA-regulated Drug | |
|---|---|
| U.S. FDA-regulated Device | |
| Product manufactured in and exported from the U.S. | |
| Data Monitoring | No |
Study Description
| Brief Summary | This trial tests whether home blood-pressure monitoring supported by community health workers improves control compared with clinic-only care. |
|---|---|
| Detailed Description | Participants with hypertension are randomised to home monitoring with community health worker support or clinic-only care. Blood pressure control is assessed at six months. |
Conditions
| Condition | Hypertension |
|---|---|
| Keywords | hypertension home monitoring community health workers |
Study Design
| Study Type | Interventional |
|---|---|
| Primary Purpose | Treatment |
| Study Phase | N/A |
| Interventional Study Model | Parallel Assignment |
| Number of Arms | 2 |
| Masking | None (Open Label) |
| Allocation | Randomized |
| Enrollment | 1200 [Estimated] |
Arms and Interventions
| Arms | Assigned Interventions |
|---|---|
| Experimental: Home monitoring | Device: Home blood-pressure monitor Behavioral: Home blood-pressure monitoring with CHW support |
| Active Comparator: Clinic-only care |
Outcome Measures
| Primary Outcome Measures | Proportion achieving blood pressure below 140/90 mmHg Time Frame: 6 months |
|---|---|
| Secondary Outcome Measures | Medication adherence Time Frame: 6 months |
Eligibility
| Minimum Age | 35 Years |
|---|---|
| Maximum Age | 75 Years |
| Ages | 35 Years to 75 Years (Adult, Older Adult) |
| Sex | All |
| Gender-based Eligibility | |
| Gender Eligibility Description | |
| Accepts Healthy Volunteers | No |
| Criteria | <p>Inclusion Criteria:</p><ul><li>Adults aged 35 to 75 years with diagnosed hypertension.</li></ul><p>Exclusion Criteria:</p><ul><li>Secondary hypertension under specialist care.</li></ul> |
Contacts/Locations
| Central Contact Person | Dr Shahin Alam htn-home@bmu.ac.bd |
|---|---|
| Study Officials | |
| Location | Barishal, Barishal, Bangladesh, 8200 Status: Active, not recruiting Facility: Sher-e-Bangla Medical College, Barishal |
IPD Sharing
| IPD information | Plan to Share IPD: Not provided |
|---|
References
| Citations | |
|---|---|
| Links | |
| Available IPD/Information |
Document Section
| Documents |
|---|