Implementation of DCP3 Strategies to Manage and Control Hypertension Among Hypertensive Patients in Pakistan: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months
研究概览
简要总结
This study aims to enable delivery of a multi-component intervention comprising of strategies based on Disease Control Priorities 3rd edition for management of hypertension among hypertensive patients. The secondary objective is to test the feasibility, acceptability and adaptability of a multi-component intervention delivered at a tertiary level health-care facility in the cultural context of Pakistan. A formative research study was conducted before so as to develop and test the intervention in a tertiary care hospital setting. The investigators employed qualitative research methods to explore the feasibility, applicability, and acceptance of DCP3 based intervention comprising of strategies for hypertension management. Focus group discussions and in-depth interviews with selected study participants were conducted at Armed Forces Institute of Cardiology (AFIC/NIHD), Rawalpindi for which a prior written and verbal consent was obtained from all research participants. The study adhered to the ethical principles of involving human subjects in the research. All information provided by the participants was recorded and was kept strictly confidential.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Pakistani nationals both male and female of age 18 years and above will be invited to participate in the study
- •Similarly; known hypertensive patients having a systolic blood pressure of ≥140 mmHg on current treatment will be included &
- •Patients with co-morbidities will also be included such as those suffering from cardiac ailments (angina or transient ischemic attack (TIA) and diabetes
排除标准
- •• Patients with compromised neurological or cognitive state who are unable to provide their consent will be excluded
- •Patients suffering from non-cardiovascular diseases and life-threatening illnesses such as angiographically proven coronary disease, peripheral or cerebral vascular disease, pulmonary hypertension, having history of myocardial infarction, stroke/PCI/stent or high-risk conditions will be excluded from participation
- •Patients with chronic conditions and co-morbidities requiring surgical intervention or treatment such as cardiomyopathies or congenital abnormalities &
- •Patients receiving dialysis will also be excluded from the study
结局指标
主要结局
Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months
时间窗: 03 months
Number of participants with reduced salt intake from baseline measurements as compared to follow up measurements at 03 months
时间窗: Baseline to follow up in 03 months
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Number of participants with increased level of physical exercise compared from baseline measurements to follow up measurements at 03 months
时间窗: 03 months
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Number of participants with regular compliance to medications from baseline measurement compared with follow up measurements at 03 months
时间窗: 03 months
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
次要结局
未报告次要终点
研究者
Subhana Akber Khan
Principal Investigator PhD Scholar (Public Health)
Health Services Academy, Islamabad, Pakistan