Clinical trial NCT06148142: Effectiveness of a Community Pharmacy-based Health Promotion Program on Hypertension in Bangladesh and Pakistan
Official title: Effectiveness of a Community Pharmacy-based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Pharmacy
Cost-effectiveness
Keywords: Hypertension control
quality-adjusted life year gained
Cost-effectiveness
South Asia
Lead sponsor: Hitotsubashi University
Sponsor class: OTHER
Collaborators: name: Global Public Health Research Foundation
First posted: 2023-11-28
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm cluster randomized controlled trial (cRCT) will be conducted among hypertensive subjects in Bangladesh and Pakistan.
Primary purpose: PREVENTION

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.

Detailed description: Globally, hypertension is a leading cause of cardiovascular disease and death. Approximately two-thirds of the world's 1.28 billion hypertensive adults live in low- and middle-income countries (LMICs). South Asian countries have experienced a steep rise in hypertension prevalence, with Bangladesh, India, and Pakistan having 48.0%, 52.3%, and 46.2%. Hypertension in low-income countries is disproportionately caused by rapid urbanization, unhealthy lifestyles, and inactivity. In LMICs, though awareness, treatment, and control of hypertension remain unacceptably low, mostly because of poor medication adherence, limited health resources, and difficulties accessing healthcare. Furthermore, a systematic review suggested that factors such as inadequate health care information, dissatisfaction with the services provided, and fewer interactions with physicians contribute significantly to medication nonadherence. LMICs with weak health literacy, poor health systems, and high cardiovascular disease fatality rates have a disproportionately high prevalence of hypertension. Consequently, most hypertensive individuals take medications only when symptomatic and lead sedentary lifestyles despite being aware of dietary recommendations. Therefore, this study aims to evaluate the impact and cost-effectiveness of enhanced pharmacist care on blood pressure (BP) control and treatment adherence across two South Asian countries.

Objectives:

In this study, the investigator will test the effectiveness and cost-effectiveness of enhanced pharmacy-based care provided to community people in two South Asian countries (Bangladesh and Pakistan) on blood pressure control and treatment adherence. It is the first multi-country trial to evaluate pharmacy-based health promotion in these two countries, focusing on the role of pharmacist in hypertension treatment. This study hypothesizes that hypertensive participants receiving the community pharmacy-based health intervention will achieve the following:

* Reduced SBP and/or DBP;
* Treatment adherence and BP controlled to target (SBP 140 mmHg and DBP 90 mmHg) increased;
* Cardiovascular disease, heart failure or stroke are less likely to cause hospitalizations.
* Hypertension management costs are reduced;
* Changes in lifestyle behaviors, such as reducing salt intake, smoking, and physically inactivity.

Methods:

Study design and setting:

Two-arm cluster randomized controlled trial (cRCT) will be conducted among hypertensive subjects in Bangladesh and Pakistan. Randomization clusters are community pharmacies. Each country will follow a two-arm cRCT design. According to 4.65% BP reduction with 49.78 standard deviation, the estimated sample size for Bangladesh is around 3600 at 80% power and 5% significance. Approximately 10% of participants will be selected based on Bangladesh sample from Pakistan (360 hypertensive patients, four pharmacies). The average number of hypertensive participants per pharmacy is 90.

Study participants:

As part of the census, participants who come to the pharmacy to purchase hypertensive medication will be listed with their basic information. The following information will be needed: their name, address, gender, duration of hypertension, who will be taking the medication, and at least two contact numbers. In order to confirm whether prospective hypertensive participants are hypertensive, their blood pressure will be measured again. Both male and female participants will be invited to participate. The eligibility criteria include: (1) aged 18 years and above, (2) hypertensive (defined (a) SBP ≥140 mmHg and DBP ≥90 mmHg and/or taking antihypertensive medications), (3) having suboptimal medication adherence to antihypertensive drugs according to the Morisky Medication Adherence Scale, (4) capable of communicating verbally in local language, (5) permanent resident of the study area, (6) access to mobile phone, and (7) consent to participate. Exclusion criteria will be: (1) pregnant and lactating women, (2) individuals with advanced medical disease, (3) those having cognitive and psychiatric problems, (4) involvement in any other interventional study, and (5) individuals who are unable to give informed consent. Pharmacists' inclusion criteria include: (1) ensuring sufficient amount of time to implement intervention on hypertensive participants, (2) consent to participate and (3) able to operate smartphone or tablet. Screening for patients' eligibility will be conducted by the CP during regular visits, and upon deeming them eligible, the CP will inform the principal investigator or research assistant of this study to approach the patients, briefly explain the study, and ask to sign informed consent.

Randomization: Community pharmacies will then be randomised to one of two parallel groups (allocation ratio 1:1) using a computer-generated random number sequence. Participants and pharmacies will be assigned to intervention and control groups in a 1:1 ratio.

Training of the pharmacists:

A mandatory communication training will enhance treatment integrity, since pharmacist skills and competences will determine the quality of the intervention. Before the study begins, CP in the intervention arm will receive a training involving both theoretical and practical sessions. It will cover prevalence, risk factors, complications, and diagnosis of hypertension, as well as non-pharmacological ways of preventing it. On the practical side, CPs will learn how to measure blood pressure using a manual sphygmomanometer, interpret the measurements, and educate and counsel hypertensive patients through audio-visual presentations. As part of the intervention strategy, blood pressure control, identification of hypertension-related complications, health education, medication and lifestyle modification counselling, follow-up, and referral to a medical practitioner or hospital will be provided.

Eligibility criteria: Inclusion Criteria:

* 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

Pharmacists' inclusion criteria include:

* Ensuring a sufficient amount of time to implement intervention on hypertensive participants
* Consent to participate
* Able to operate smartphone or tablet.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Blood pressure change
timeFrame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
Secondary outcomes:
measure: Changes in blood pressure from baseline to follow up
timeFrame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
measure: Changes of Quality of life
timeFrame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
measure: Knowledge of healthy lifestyle
timeFrame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
measure: Changes in salt intake
timeFrame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
measure: Rate of treatment adherence
timeFrame: Time Frame: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Global Public Health Research Foundation
Study officials:
References: