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CTRI Number  CTRI/2023/11/059942 [Registered on: 17/11/2023] Trial Registered Prospectively
Last Modified On: 10/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Psychiatric problems faced by Patients of Chronic Kidney Disease: A Hospital Based study 
Scientific Title of Study   Prevalence of Psychiatric Morbidity and its Clinical Correlates in Patients of Chronic Kidney Disease: A Hospital Based 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  Dr. Tarun Saini 
Designation  PG RESIDENT Department of psychiatry 
Affiliation  pacific medical college and hospital 
Address  ROOM NO 7 Unit 1 DEPARTMENT OF PSYCHIATRY Pacific Medical College and Hospital Udaipur Rajasthan 313001 India

Udaipur
RAJASTHAN
313001
India 
Phone    
Fax    
Email  tarunsaini45784@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushil Kherada 
Designation  Professor 
Affiliation  Pacific Medical College and Hospital 
Address  ROOM 07 Unit 1 DEPARTMENT OF PSYCHIATRY pacific medical college and hospital bhillon ka bedla udaipur

Udaipur
RAJASTHAN
313001
India 
Phone  9413287101  
Fax    
Email  sushil.kherada@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Tarun Saini 
Designation  PG RESIDENT 
Affiliation  Pacific Medical College and Hospital 
Address  ROOM NO 107 Unit 1 DEPARTMENT OF PSYCHIATRY PACIFIC MEDICAL COLLEGE AND HOSPITAL BHILLON KA BEDLA UDAIPUR

Udaipur
RAJASTHAN
313001
India 
Phone  7837370133  
Fax    
Email  tarunsaini45784@gmail.com  
 
Source of Monetary or Material Support  
Pacific Medical collage and Hospital bhilon ka bedla udaipur 
 
Primary Sponsor  
Name  nil  
Address  nil 
Type of Sponsor  Other [] 
 
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 Tarun saini  Pacific medical college and hospital  room no 07 Unit 1 pacific medical college and hospital bhillon ka bedla udaipur
Udaipur
RAJASTHAN 		 7837370133

tarunsaini45784@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Pacific Medical College and Hospital, Udaipur, Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of both genders who are between 18 to 60 years of age.
Patients who are willing to give their consent for the study.
 
 
ExclusionCriteria 
Details  Patient diagnosed to have mental illness prior to the onset of chronic kidney disease .
Patient who refused to give consent for study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
prevalence and severity of psychiatric disorders in people with CKD  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
depression, anxiety  at baseline 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   11/12/2023 
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 Yet Recruiting 
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   Title of the Project “Prevalence of psychiatric morbidity and its clinical correlates in in patients of chronic kidney disease”

A.    Expected outcome & Application: We anticipate that kidney function disease patients may exhibit a wide range of psychiatric symptoms secondary to their illness and treatment-related experiences. The severity of depression and anxiety is particularly expected to be higher in patients with chronic and disabling symptoms, based on their socio-demographic and clinical profiles.

CKD patients are undergoing tremendous physical, psychological, emotional and financial stress of high order. This may lead to negative outlook in these patients, because of dependency and disability. Psychiatric comorbidity in CKD is an important factor in determining the treatment outcome as it is associated with poor adherence. So it becomes important to evaluate the prevalence and severity of psychiatric disorders in people with CKD. Proper identification and treatment of psychiatric comorbidity will help improve treatment adherence, quality of life and illness outcome.


Research question:

Ø  What is the prevalence of various psychiatric morbidities in CKD patients?

Ø  What is the impact of individual patient variables on these psychiatric morbidities?

. Aims and objectives:

To estimate the prevalence of psychiatric morbidity in patients with chronic kidney disease

To study the nature and severity of psychiatric manifestations in patients with CKD, on conservative treatment, on hemodialysis

To study the role of support systems, functional level, treatment adherence in relation to psychiatric illness.

Selection criteria for participants:

A.    Inclusion criteria:

Patients of both genders who are between 18 to 60 years of age.

       Patients who are willing to give their consent for the study.

         Exclusion criteria:

Patient diagnosed to have mental illness prior to the onset of CKD

  Refused to give consent to study

. Sampling: 

 

A. Population: Cancer Patients coming to NEPHROLOGY OPD/IPD at PMCH.

 

B. Sampling method: Convenient sampling

 

C. Sample size: 144 (72) each group)

·       INSTRUMENTS OF THE STUDY:

         The following instruments will be applied on all study subjects:

A.    MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW (MINI):

B.    KPS ( Karnofsky performance status)

C.    BDI ( Becks depression inventory)

D.    BAI ( Becks Anxiety inventory)

 

Ø  MINI INTERNATIONAL NEUROPSYCHIATRIC INTERVIEW (MINI): MINI is designed as a brief diagnostic interview to meet the need for short but accurate structured psychiatric interview for multicentre clinical trials and epidemiological studies. It acts as a first step in outcome tracking in non-research clinical settings. It assesses the 17 most common disorders in mental health.

 

Ø  KPS: The Karnofsky Performance Scale Index is an assessment tool for functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. In most serious illnesses, the lower the Karnofsky score, the worse the likelihood of survival

 

Ø  BDI: The Beck Depression Inventory (BDI) is widely used to  screen for depression and to measure behavioural manifestations and severity of depression BDI cut-off scores to be used with affective disorder patients: scores from 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.

 

Ø  BAI: Beck Anxiety Inventory is a well accepted self-report screening measure of the severity of anxiety in adults and adolescents for use in both clinical and research settings. Total score (0–63), where Minimal Level of Anxiety (0–7); Mild Anxiety (8–15); Moderate Anxiety (16–25); Severe Anxiety (26–63)

 

 


 
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