Interventional study for the assessment of medication adherence in adult hypertensive out-patients in a tertiary care hospital in rural haryana
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- 1. To estimate the medication adherence rate among hypertensive patients at SHKM GMC
研究概览
简要总结
Hypertension is a major global health issue, especially in India, affecting over billion people. Poorly controlled hypertension increases the risk of serious cardiovascular events and mortality. Adherence to medication is crucial but often low due to various factors. Educational strategies such as patient education sessions and telephonic counselling can improve adherence and outcomes. However, the most effective stralegy for rural Haryana’s hypertensive patients requires specific studies considering literacy, culture and healthcare access.
Material and methods:
A customized case record form will collect demographic and clinical data, including patient details, disease factors, and medication information. Face- to-face interviews and medical records will be used for data collection. The Hill-Bone Medication Adherence Scale will assess adherence.
Patients will be Categorized into adherent and non-adherent groups based on the scale. Non-adherent patients will be randomly assigned to Group A or Group B. Non-adherent patients will be divided into two groups: Group A receives an interactive educational module on medication adherence for one month, while Group B receives usual care. The efficacy of the intervention will be assessed using the Hill-Bone medication adherence scale and blood pressure measurement at baseline, first follow-up visit (short-term assessment after one month), and final follow-up after three months.
Safety will be assessed through adverse drug reaction monitoring using CDSCO reporting forms and the WHO-UMC database. Any dropouts due to adverse events will be reported and managed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of Essential Hypertension on oral anti-hypertensive drugs for at least 1 month visiting the medicine OPD of SHKM GMC.
- •Hypertensive patients on oral anti-hypertensive therapy.
- •Patients who are willing to give written informed consent.
排除标准
- •Patients of secondary hypertension Patients with severe comorbidities or cognitive impairments that may affect their ability to participate effectively Hypertension patients on injectables.
- •Patients with psychiatric illness Critically ill patients.
- •Pregnant and lactating women.
- •Patients who are not willing to give written informed consent.
结局指标
主要结局
1. To estimate the medication adherence rate among hypertensive patients at SHKM GMC
时间窗: Baseline, After 4weeks, After 8weeks
2. To evaluate the efficacy of an educational module aimed at enhancing medication compliance among non-adherent patients.
时间窗: Baseline, After 4weeks, After 8weeks
次要结局
- 1. To determine factors linked with adherence to oral antihypertensive medications among hypertensive outpatients at SHKM GMC.(2. To evaluate the relationship between reduction in blood pressure & adherence to oral antihypertensive medication.)
研究者
Rajat Bhardwaj
Shaheed Hasan Khan Mewati Government Medical College
