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临床试验/CTRI/2024/07/070937
CTRI/2024/07/070937尚未招募不适用

Assessment of Diabetes Distress and Its Impact on Glycemic Control and Diabetic Complications: A Cross-Sectional Study

未提供1 个研究点 分布在 1 个国家目标入组 354 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
354
试验地点
1
主要终点
Various aspects of distress among type 2 diabetes mellitus patients

研究概览

简要总结

INTRODUCTION

Diabetes is a disease that is considered to be difficult for patients to manage given that it incorporates many restricting instructions. Psychological comorbidity, like depression and/or diabetic distress, are prevalent among patients with T2DM and have been linked with less effective outcomes of the treatment Diabetes distress can influence the relationship between depression and glycaemic control.

OBJECTIVE

To translate and validate PAID (Problem areas in diabetes) scale into Kannada and Malayalam languages.

To evaluate the diabetes-associated distress and its association with glycaemic control and diabetes complications among type 2 diabetes patients.

JUSTIFICATION OF THE STUDY

T2DM often results in mental health conditions commonly; depression and diabetes distress. This gives rise to patient’s risk for mortality, poor disease management, diabetes-related complications, and decreased quality of life. Depression and diabetes distress have resulted in poor medication adherence and a decrease in self-care leading to negative outcomes in Type 2 diabetes patients. It has been reported that diabetes patients usually experience depression and anxiety. A meta-analysis reported that about 36% of T2DM experience distress. However, the data on diabetes distress and its association with glycaemic control and diabetic complications among Indian patients are limited which makes it a novel area to be explored.

METHODOLOGY

PAID (Problem areas in diabetes) scale will be translated into Malayalam and Kannada. Patients with a confirmed diagnosis of type 2 Diabetes, who are attending inpatient and outpatient units of Justice K.S Hedge charitable hospital in an age group above 18 years, diagnosed at least 2 years back and willing to participate in the study. A data collection form will be used to collect data, each participant will complete the PAID scale. Diabetic distress was determined using the questionnaire.

STATISTICAL ANALYSIS

The data will be summarised using descriptive statistics, Mean, Standard deviations, Median, Inter Quartile Range, frequency, and percentage. Shapiro-wilk test will be used to evaluate the normality of data. the reliability of the translation will be assessed by Cronbach alpha score, and the validity of the translation will be determined using person correlation/Spearman rank correlation. Inferential statistics will be analysed using Chi-square test, Unpaired t-test/Mann-Whitney U test, Quade’s ANCOVA test, Multiple linear Regression analysis, Univariate regression analysis, Multivariate Logistic Regression Analysis, Odds Ratio

OUTCOME MEASURES

This study will give an overview of various aspects of distress among type 2 diabetes mellitus patients and its associations with glycaemic control and complications.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Type 2 Diabetes patients above 18 years of age of either gender who were diagnosed at least 2 years back.

排除标准

  • Patients with psychiatric disorders or mental illnesses 2) Critically ill patients 3) Immunocompromised patients 4) Pregnant women.

结局指标

主要结局

Various aspects of distress among type 2 diabetes mellitus patients

时间窗: 8 Months

次要结局

  • Diabetes-associated Distress association with glycemic control and diabetes complications among type 2 diabetes patients(8 Months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Amna Reem

NGSM Institute of pharmaceutical science

研究点 (1)

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