| CTRI Number |
CTRI/2024/10/075616 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Impact of Anxiety, Depression, and Quality of Life in Chronic Kidney Disease Patients |
|
Scientific Title of Study
|
Assessment and evaluation of anxiety and depression on quality of life among chronic kidney disease patients in the nephrology ward of a tertiary care hospital: A cross-sectional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHAVARDHAN |
| Designation |
PG STUDENT |
| Affiliation |
KLE COLLEGE OF PHARMACY BELAGAVI |
| Address |
Dept. of Pharmacy Practice,
KLE College of Pharmacy, Belagavi,
Nehru Nagar,
Belagavi.
590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9886220409 |
| Fax |
|
| Email |
harshpatil000.hp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Geetanjali Salimath |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KLE COLLEGE OF PHARMACY BELAGAVI |
| Address |
Dept. of Pharmacy Practice,
KLE College of Pharmacy, Belagavi,
Nehru Nagar,
Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9902687176 |
| Fax |
|
| Email |
geetanjalisalimath@klepharm.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Geetanjali Salimath |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KLE COLLEGE OF PHARMACY BELAGAVI |
| Address |
Dept. of Pharmacy Practice,
KLE College of Pharmacy, Belagavi,
Nehru Nagar,
Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9902687176 |
| Fax |
|
| Email |
geetanjalisalimath@klepharm.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLEs DrPRABHAKAR KORE HOSPITAL AND MRC BELAGAVI |
| Address |
Nehru Nagar,
Belagavi,
PIN: 590010. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GEETANJALI SALIMATH |
KLEs Dr. PRABHAKAR KORE HOSPITAL AND MRC BELAGAVI |
DEPT OF PHARMACY PRACTICE
4 floor
KLEs Dr. PRABHAKAR KORE HOSPITAL AND MRC BELAGAVI
Belgaum
KARNATAKA |
9902687176
geetanjalisalimath@klepharm.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLECOPBGM ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The study included patients over the age of 18 who had a confirmed diagnosis of Chronic Kidney Disease (CKD),able to read and understand the language of the assessment tools used, and willing to provide informed consent and complete all study procedures. |
|
| ExclusionCriteria |
| Details |
Patients were excluded if they had incomplete demographic or laboratory data, had conditions other than Chronic Kidney Disease (CKD), were unwilling to provide necessary information, were experiencing an acute psychiatric crisis requiring immediate intervention, had a terminal illness with limited life expectancy, were unable to participate due to severe physical limitations, or were over the age of 80. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of anxiety and depression in chronic kidney disease (CKD) patients using the appropriate scales. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE CO-RELATION OF ANXIETY AND DEPRESSION WITH QOL IN CKD PATIENTS. |
6 MONTHS |
| TO ASSESS THE EFFECTS OF VARIOUS SOCIO-DEMOGRAPHIC AND DISEASE FACTORS OF ANXIETY AND DEPRESSION ON QOL IN CKD PATIENTS. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/10/2024 |
| Date of Study Completion (India) |
01/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Application of WHOQOL-BREF scale for evaluating quality of life among chronic kidney disease
patients a cross-sectional study, published in International journal of pharmaceutical Investigation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This cross-sectional study focuses on assessing the prevalence and severity of anxiety and depression in chronic kidney disease (CKD) patients and their effect on the patients’ quality of life. Using the PHQ-9 and GAD-7 scales to measure anxiety and depression, along with the WHOQOL-BREF to assess quality of life, the study aims to understand how mental health issues impact CKD patients. It also seeks to explore the influence of sociodemographic factors on these conditions, ultimately aiming to improve clinical care and treatment strategies by addressing the often-overlooked mental health challenges in CKD patients within a tertiary care hospital setting. |