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临床试验/CTRI/2024/08/072120
CTRI/2024/08/072120尚未招募不适用

Interventional study for the assessment of medication adherence in adult hypertensive out-patients in a tertiary care hospital in rural haryana

SHKM GMC1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年8月16日最近更新:

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

发起方
SHKM GMC
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rajat Bhardwaj

Shaheed Hasan Khan Mewati Government Medical College

研究点 (1)

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