Assessment of Diabetes Distress and Its Impact on Glycemic Control and Diabetic Complications: A Cross-Sectional Study
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
Amna Reem
NGSM Institute of pharmaceutical science
