Effectiveness of a Community Pharmacy-based Health Promotion Program on Hypertension in Bangladesh and Pakistan

NCT06148142 | Completed

• 1 other identifier: 2023D016
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this multi-country research project is to reduce the blood pressure of individuals with hypertension over a 18-month period in Bangladesh and Pakistan. A cluster randomized controlled trial (cRCT) will be conducted with two arms. The estimated sample size is around 3600 hypertensive adults. Bangladesh study participants will consist of 3600 hypertensive individuals. Approximately 10% of participants will be selected based on Bangladesh samples from Pakistan (360 hypertensive patients, four pharmacies). Community pharmacies will be randomised to one of two parallel groups (allocation ratio 1:1). Pharmacy professionals will provide educational training and counselling, as well as phone calls/mobile text messages and care coordination in the health sector as part of the intervention. The study will be conducted in three phases: baseline survey; intervention and follow-up; and endline survey with impact evaluation. The primary outcome will be BP reduction and the secondary outcomes will be BP controlled to target, treatment adherence, mortality or hospital admission rates resulting from hypertension and its related complications, incremental cost per quality-adjusted life year gained, improvement in knowledge on healthy lifestyle, change in dietary salt intake, and change in prevalence of current smokers.

Conditions

Blood Pressure; Pharmacy; Cost-effectiveness

Keywords

Hypertension control; quality-adjusted life year gained; Cost-effectiveness; South Asia

Outcome Measures

Primary Outcomes (1)

• Blood pressure change

  The primary effectiveness of the outcome will be evaluated by change in SBP and DBP of the patients at baseline, at 12 months and 18 months post-intervention.

  Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention

Secondary Outcomes (5)

• Changes in blood pressure from baseline to follow up

  Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention

• Changes of Quality of life

  Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention

• Knowledge of healthy lifestyle

  Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention

• Changes in salt intake

  Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention

• Rate of treatment adherence

  Time Frame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention

Study Arms (2)

Assigned Interventions

EXPERIMENTAL

The intervention to experimental/intervention group will consist of three phases: baseline survey with first time intervention implementation; second intervention at 6 months; third at 12 months and , end-line survey at 18 months. As part of the intervention within the randomized selected groups, the CP will conduct two 15-30 minute sessions throughout the intervention period, once at the baseline or first visit (T0) and once at the sixth month (T1). Face-to-face counselling sessions will be held about hypertension and its management, including lifestyle changes and drug compliance. Patients will be able to view the educational material in the pharmacy via a tablet, since audio-visual presentations make learning easier. The intervention group will receive phone call intervention at 3 months and 6 months.

Behavioral: Pharmacy based health promotion

Control group

ACTIVE COMPARATOR

In the control group, routine pharmacy services and counselling will be provided without interference during all-pharmacy visits, as per each country's pharmacy practice guidelines, and they will serve as a comparator group to determine the impact of the intervention implementation. Assessments will be completed at the same time points as those in the intervention group.

Behavioral: Pharmacy based health promotion

Interventions

Pharmacy based health promotion BEHAVIORAL

This project will consist of three phases: baseline survey with first time intervention implementation; second intervention at 6 months; third at 12 months and , end-line survey at 18 months. As part of the intervention within the randomized selected groups, the CP will conduct two 15-30 minute sessions throughout the intervention period, once at the baseline or first visit (T0) and once at the sixth month (T1). Patients will attend the two sessions at the pharmacies where they collect their prescription medication. Face-to-face counselling sessions will be held about hypertension and its management, including lifestyle changes and drug compliance.

Assigned Interventions; Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years to 90 years old
• Hypertensive (SBP ≥140 mmHg and DBP ≥90 mmHg and/or taking antihypertensive medications)
• Having suboptimal medication adherence to antihypertensive drugs
• Capable of communicating verbally in local language
• Permanent resident of the study area
• Access to mobile phone
• Consent to participate
• Ensuring a sufficient amount of time to implement intervention on hypertensive participants
• Consent to participate
• Able to operate smartphone or tablet.

You may not qualify if:

• Pregnant and lactating women
• Individuals with advanced medical disease
• Those having cognitive and psychiatric problems,
• Involvement in any other interventional study
• Individuals who are unable to give informed consent.

Sponsors & Collaborators

• Hitotsubashi University: lead
• Global Public Health Research Foundation: collaborator

Study Sites (1)

Global Public Health Research Foundation

Dhaka, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the outcome evaluators will be blinded from group allocation due to the nature of the intervention. CP will deliver the intervention and research assistants (field enumerators and supervisors) will engage in data collection from the participants. However, pharmacists and research assistants will not be blinded since they are involved in interventional processes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-arm cluster randomized controlled trial (cRCT) will be conducted among hypertensive subjects in Bangladesh and Pakistan.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 28, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)