Aim: Develop and evaluate a community pharmacy-based intervention to reduce CVD risk through optimal hypertension management among low-income urban residents (LIURs) in Bangladesh and Pakistan.
WP1 Intervention Development (Year 1)
Months 1-18
Leads: Helen Elsey, Mohammad Ismail, João Porto de Albuquerque
Activities:
Geo-mapping using OpenStreetMap, photovoice (Months 1-4)
Mixed-methods study (surveys, interviews, focus groups) (Months 3-9)
Sample Size: 10 clusters, 400 participants (40 per cluster)
Objectives:
Assess acceptability to the study participants, community pharmacists, and primary care physicians
Determine if COPE-BP can be delivered as planned
Refine trial methods
Key metrics:
Recruitment rates
Retention rates
Intervention fidelity
Percentage of complete outcome measures
WP3 Effectiveness Trial (Year 3-5)
Months 29-60
Leads: Catherine Hewitt, Saima Afaq, Zia ul Haq
Design: Pragmatic two-arm parallel cRCT with internal pilot
Sample Size: 8 clusters per city (total 32 clusters); 80 participants per cluster, totaling 2,720 participants
Primary Outcome: Systolic BP at 24 months
Secondary Outcomes: Diastolic BP at 24 months, BP Control, Medication Adherence, BMI and Waist Circumference, Physical Activity, Smoking Status, Fruit and Vegetable Intake, Dietary Salt Intake, Lipid Profile, Incident Diabetes, Estimated Glomerular Filtration Rate (eGFR), Urine Albumin Excretion, Adverse Events, All-Cause Mortality, Hospitalisations for CVD, 10-Year Risk of CVD Events
WP4 Process Evaluation (Year 2-5)
Months 12-60
Leads: Shaista Rasool, Helen Elsey
Objectives:
Assess fidelity and implementation
Understand mechanisms of change
Evaluate context and sustainability
Methods:
Quantitative: Fidelity checklist (observations at 6 and 18 months), questionnaires (AIM, FIM, IAM scales)
Qualitative: Interviews with pharmacists, physicians, and policy-makers, focus groups with LIURs
Outputs:
Implementation guide for policy and practice adaptation
Revised programme theory based on findings
WP5 Economic Analysis (Year 1-5)
Month 1-60
Leads: Naomi Gibbs, Rumana Huque, Simon Walker
Components:
Decision modelling: Headroom analysis (maximum resources for given treatment effect), value of information analysis (identify critical data needs)
