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临床试验/CTRI/2025/07/091746
CTRI/2025/07/091746尚未招募不适用

Assessment of Cardiovascular Risk Factor Among Diabetic Population using validated Heart Disease Fact Questionnaire

NGSM Institute of pharmaceutical sciences1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2025年8月5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
207
试验地点
1
主要终点
•This study will give insights on risk factors knowledge levels about heart disease of the diabetes patients.

研究概览

简要总结

Introduction

Diabetes is a metabolic disorder marked by high blood sugar due to insulin issues, causing long-term damage to organs like eyes, kidneys, nerves, and the heart. Both Type 1 (autoimmune) and Type 2 (insulin resistance) diabetes increase the risk of serious complications, especially cardiovascular diseases (CVD) like heart failure and hardened arteries, driven by shared genetic and lifestyle factors. With over 830 million people globally affected, preventing and managing CVD is a critical goal in diabetes care. Given the lack of specific tools in India, this study aims to translate, validate, and assess the reliability of the Heart Disease Fact Questionnaire and evaluate T2DM patients’ knowledge about CVD risk factors.

Need for the study

The rising global prevalence of DM and its strong link to CVD highlight the urgent need for effective health education and awareness of risk factors among diabetic patients. A lack of knowledge can lead to poor health management and increased cardiovascular events. Therefore, assessing diabetic patients’ understanding of heart disease risk factors is crucial for identifying educational needs and developing targeted health promotion strategies. The HDFQ is a valuable tool for this assessment of the knowledge about the CVD risk factors among DM patients. The results will not only reveal current awareness levels but also guide healthcare providers in addressing specific educational gaps.

Objectives of the study

·       To translate, validate, and assess the reliability of the Heart Disease Fact Questionnaire for patients with diabetes mellitus.

·       To assess the knowledge regarding cardiovascular risk factors using Heart Disease Fact Questionnaire among the diabetes mellitus patients.

Methodology

The study is designed as an observational cross-sectional study to be conducted at the Department of General Medicine, Justice K S Hedge Charitable Hospital in Deralakatte, Mangaluru. A sample size of 207 diabetic patients, aged 18 and above, will be recruited using convenience sampling. Inclusion criteria include patients willing to provide consent and diagnosed with type 2 diabetes, while exclusion criteria encompass those with severe illnesses, psychiatric conditions, pregnant or lactating women, and patients with type 1 diabetes. The study will span eight months, from July 2025 to February 2026. Data collection will involve a demographic and clinical details form, alongside the Heart Disease Facts Questionnaire (HDFQ), a 25-item tool assessing knowledge of heart disease risk factors in diabetic patients. The HDFQ will be translated into Kannada and Malayalam, validated through a forward-backward translation process, and assessed for reliability using the test-retest method and Cronbach’s alpha. Statistical analysis will be performed using SPSS software version 29.0, with qualitative data expressed as frequency and percentage, and quantitative variables as  (mean, standard deviation, median). Logistic regression will identify factors linked to knowledge levels, with a significance threshold set at a p-value of 0.05 or lower.

Anticipated outcome

This study will give insights on risk factors knowledge levels about heart disease of the diabetes patients. This study also will provide the information on factors associated with knowledge levels about the heart disease among the diabetes patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients willing to give consent 2.Patient of 18 years and above 3.Diagnosed with type 2 diabetes with or without comorbidities.

排除标准

  • 1.Patient with severe illness who can’t communicate properly 2.Psychiatric, cognitive, and terminal illness patients 3.Pregnant and lactating women 4.Patients with type 1 diabetes.

结局指标

主要结局

•This study will give insights on risk factors knowledge levels about heart disease of the diabetes patients.

时间窗: 8 months

次要结局

  • This study also will provide the information on factors associated with knowledge levels about the heart disease among the diabetes patients.(8 months)

研究者

发起方
NGSM Institute of pharmaceutical sciences
申办方类型
Other [Academic Institute]
责任方
Principal Investigator
主要研究者

Sakshi C Salian

NGSM Institute of pharmaceutical sciences

研究点 (1)

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