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临床试验/CTRI/2025/07/091662
CTRI/2025/07/091662尚未招募不适用

A Multidimensional Cross-Sectional Analysis of Chronic Kidney Disease Patients: Assessing Quality of Life, Quality of Sleep, Mental Health and Polypharmacy.

Kasturba Medical College, Manipal1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
194
试验地点
1
主要终点
Assess quality of life and its domains in CKD patients using the KDQOL scale.

研究概览

简要总结

Chronic Kidney Disease (CKD) is a progressive condition associated with significant physical, psychological, and social consequences. With the rising trend of CKD cases in India, there is a growing need to understand the multidimensional burden it imposes on patients. This cross-sectional observational study aims to assess the quality of life, sleep quality, mental health status, cognitive function, and polypharmacy among CKD patients across all stages of the disease.

The study was conducted in the Department of Nephrology at Kasturba Medical College, Manipal, and involved a total of 194 patients diagnosed with CKD. Participants were recruited irrespective of the stage of CKD and were assessed using validated tools: the Kidney Disease Quality of Life instrument (KDQOL), Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9) for depression, Generalized Anxiety Disorder-7 (GAD-7) for anxiety, and the Mini-Cog test for cognitive impairment. Data related to medication usage were also collected to evaluate polypharmacy.

The objective of this study is to provide a comprehensive evaluation of the multidimensional impact of CKD, beyond its physiological effects. By correlating clinical and psychological variables, the study aims to highlight the need for integrated patient-centered care in CKD management. The results may offer insights for clinicians and policymakers to design better supportive interventions and improve overall patient outcomes.

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

  • Male and Female participants of age group more than 18 years.
  • Patients Diagnosed with CKD including patients on Dialysis.

排除标准

  • Non consenting patients or those unable to give informed consent.
  • Patients who are unable to understand or comprehend the questions and answer them.
  • 3.Critically ill patients.
  • 4.Patients who have had a recent major surgery or hospitalization less than 3months.
  • 5.Patients with severe visual or hearing impairments.
  • 6.Patients diagnosed with Psychosis.
  • 7.Pregnant women.

结局指标

主要结局

Assess quality of life and its domains in CKD patients using the KDQOL scale.

时间窗: Being a cross sectional study only one time interval outcome is measured.

Determine prevalence and severity of poor sleep quality using the PSQI.

时间窗: Being a cross sectional study only one time interval outcome is measured.

Screen for cognitive impairment using the Mini-Cog test.

时间窗: Being a cross sectional study only one time interval outcome is measured.

Evaluate depressive symptoms using the PHQ-9.

时间窗: Being a cross sectional study only one time interval outcome is measured.

Assess anxiety symptoms using the GAD-7 scale.

时间窗: Being a cross sectional study only one time interval outcome is measured.

Examine the association between polypharmacy and quality of life in CKD patients.

时间窗: Being a cross sectional study only one time interval outcome is measured.

次要结局

  • 1. To determine the association between CKD severity & outcomes in Quality of life, Quality of sleep, & Mental health status in the study population.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

BARATH GANESH A

Kasturba Medical College, Manipal.

研究点 (1)

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