Prevention and management of hypertension to reduce cardiovascular disease risk in low-income urban residents (LIURs) in Bangladesh and Pakistan. Circulatory System
Conditions
Interventions
Current interventions as of 06/03/2026:
Clusters of community pharmacies will be randomly allocated to one of two arms using minimisation:
1. Intervention Arm: Participants in the intervention arm w
Sponsors
National Institute for Health and Care Research
Eligibility
Sex/Gender
All
Age
30 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 06/03/2026: 1. Aged 30 years or older. 2. Having uncontrolled hypertension, defined as having a systolic BP =140 mm Hg or a diastolic BP =90 mm Hg. This includes both newly diagnosed patients and those with a previous diagnosis of hypertension. 3. A stable resident (living for 6 months or more) of the defined cluster locality and available for follow-up visits. 4. Able to provide informed consent. Previous key inclusion criteria: 1. Aged 30 years or older. 2. Diagnosed with hypertension, which is defined as either the current use of antihypertensive medications or having a persistently elevated blood pressure (systolic BP =140 mm Hg or diastolic BP =90 mm Hg). 3. A stable resident (living for 6 months or more) of the defined cluster locality and available for follow-up visits. 4. Able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy. 2. Individuals with advanced medical diseases, such as those on dialysis, with liver cirrhosis, or with cancer. 3. Individuals with a history of severe allergies or severe adverse reactions to antihypertensive medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 06/03/2026: 1. Feasibility of the COPE-BP intervention, assessed by recruitment rate (% of eligible participants enrolled) and retention rate (% completing 4-month follow-up), measured from study screening logs and participant records at baseline and 4 months. 2. Intervention acceptability measured using validated questionnaires: ‘Acceptability of Intervention Measure’ (AIM), ‘Feasibility of Intervention Measure’ (FIM) and Intervention Appropriateness Measure (IAM) at the end of the 4-month implementation period . 3. Data completeness measured by the proportion of participants with complete outcome data at 4 months post-randomisation. 4. Contamination between trial arms measured using a survey of control-arm pharmacies during the trial period. 5. Feasibility of collecting economic data measured using Resource Use questionnaires at baseline and 4 months post-randomisation. 6. Standard Deviation of the mean difference in systolic blood pressure between trial arms will be determined to inform the main trial sample size calculation. Previous primary outcomes: 1. Feasibility of the COPE-BP intervention, assessed by recruitment rate (% of eligible participants enrolled) and retention rate (% completing 6-month follow-up), measured from study screening logs and participant records at baseline and 6 months. 2. Intervention acceptability measured using validated questionnaires: ‘Acceptability of Intervention Measure’ (AIM), ‘Feasibility of Intervention Measure’ (FIM) and Intervention Appropriateness Measure (IAM) at the end of the 6-month implementation period. 3. Data completeness measured by the proportion of participants with complete outcome data at 6 months post-randomisation. 4. Contamination between trial arms measured using a survey of control-arm pharmacies during the trial period. 5. Feasibility of collecting economic data measured using Resource Use questionnaires at baseline and 6 months post-randomisation. 6. Standard Deviation o | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcomes as of 06/03/2026: 1. Systolic Blood Pressure measured using standardised digital blood pressure monitors at baseline (month 0) and follow-up (month 4). 2. Diastolic Blood Pressure measured using standardised digital blood pressure monitors at baseline (month 0) and follow-up (month 4). 3. Blood Pressure Control (defined as systolic BP <140 mm Hg and diastolic BP <90 mm Hg) measured using standardised digital blood pressure monitors at baseline (month 0) and follow-up (month 4). 4. Very Poorly Controlled Blood Pressure (defined as systolic BP =160 mm Hg or diastolic BP =100 mm Hg) measured using standardised digital blood pressure monitors at baseline (month 0) and follow-up (month 4). 5. Adherence to Antihypertensive Medications measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale (HB-HBP) at baseline (month 0, for those already diagnosed) and follow-up (month 4). 6. Body Mass Index (BMI) and Waist Circumference measured using a stadiometer, weight machine, and standard measuring tape at baseline (month 0) and follow-up (month 4). 7. Lifestyle Risk Factors (including physical activity, smoking status, fruit and vegetable intake) measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), a smoking status questionnaire, and a Food Frequency Questionnaire (FFQ) at baseline (month 0) and follow-up (month 4). 8. Dietary Salt Intake measured using a urine sodium excretion test from a spot urine sample at baseline (month 0) and follow-up (month 4). 9. Lipid Profile measured using a fasting blood sample at baseline (month 0) and follow-up (month 4). 10. Diabetes measured using HbA1c levels from a blood sample at baseline (month 0) and follow-up (month 4). 11. Kidney Function (including eGFR and urine albumin excretion) measured using a serum creatinine test and a urine albumin-to-creatinine ratio (UACR) at baseline (month 0) and follow-up (month 4). 12. Health-Related Quality of Life measu | — |
Countries
Bangladesh, Pakistan
Contacts
Public ContactSaima Afaq
Outcome results
None listed