Effectiveness of a Community Pharmacy-based Health Promotion Program on Hypertension in Bangladesh and Pakistan: Study Protocol for a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Blood pressure change
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Blood pressure change
时间窗: Participants will be assessed at baseline, at baseline, at 12 months and 18 months post-intervention
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.
次要结局
- 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)
研究者
Md. Mizanur Rahman, PhD
Associate Professor
Hitotsubashi University