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CTRI Number  CTRI/2025/07/091662 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Observing How Chronic Kidney Disease affects Quality of Life, Sleep and Mental Health. 
Scientific Title of Study   A Multidimensional Cross-Sectional Analysis of Chronic Kidney Disease Patients: Assessing Quality of Life, Quality of Sleep, Mental Health and Polypharmacy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BARATH GANESH A 
Designation  1st year Junior Resident 
Affiliation  Kasturba Medical College, Manipal. 
Address  Department of Pharmacology, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka-576104, India.

Udupi
KARNATAKA
576104
India 
Phone  9894770921  
Fax    
Email  barathganesh.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  BHARTI CHOGTU MAGAZINE 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Pharmacology, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka-576104, India.

Udupi
KARNATAKA
576104
India 
Phone  9901728668  
Fax    
Email  bharti.magazine@manipal.edu  
 
Details of Contact Person
Public Query  
Name  BARATH GANESH A 
Designation  1st year Junior Resident 
Affiliation  Kasturba Medical College, Manipal. 
Address  Department of Pharmacology, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka-576104, India.

Udupi
KARNATAKA
576104
India 
Phone  9894770921  
Fax    
Email  barathganesh.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Nephrology, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka, India-576104. 
 
Primary Sponsor  
Name  Kasturba Medical College, Manipal 
Address  Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka-576104, India. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Barath Ganesh A  Kasturba Medical College and Kasturba Hospital  Department of Nephrology, Kasturba Medical College, Madhav Nagar, Manipal, Udupi, Karnataka-576104, India.
Udupi
KARNATAKA 		 9894770921

barathganesh.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male and Female participants of age group more than 18 years.

2. Patients Diagnosed with CKD including patients on Dialysis.  
 
ExclusionCriteria 
Details  1. Non consenting patients or those unable to give informed consent.

2. 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.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess quality of life and its domains in CKD patients using the KDQOL scale.

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

Screen for cognitive impairment using the Mini-Cog test.

Evaluate depressive symptoms using the PHQ-9.

Assess anxiety symptoms using the GAD-7 scale.

Examine the association between polypharmacy and quality of life in CKD patients.  		 Being a cross sectional study only one time interval outcome is measured. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the association between CKD severity & outcomes in Quality of life, Quality of sleep, & Mental health status in the study population.



2. To identify sociodemographic & clinical factors (e.g., comorbidities, polypharmacy) associated with poor outcomes in quality of life, sleep, & mental health among CKD patients.



3. To analyze the correlation between quality of life, sleep quality, & mental health with clinical/demographic factors (age, gender, CKD duration, comorbidities) in CKD patients.  		 Being a cross sectional study only one time interval outcome is measured. 
 
Target Sample Size   Total Sample Size="194"
Sample Size from India="194" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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