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CTRI Number  CTRI/2024/09/073820 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study of the satisfaction of family members of ICU patients with the care provided in the ICU of a government hospital based on a standard set of questions. 
Scientific Title of Study   Family satisfaction with the quality of care in the intensive care units at a tertiary care government hospital.A descriptive questionnaire 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  Sabahat Tazeen 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College,Aligarh Muslim University 
Address  Department of Anaesthesiology and Critical care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8210370958  
Fax    
Email  sabahattazeen73@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shahna Ali 
Designation  Assistant Professor 
Affiliation  Jawaharlal Nehru Medical College,Aligarh Muslim University 
Address  Department of Anaesthesiology and Critical care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9411979684  
Fax    
Email  drshahna.farhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sabahat Tazeen 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College,Aligarh 
Address  Department of Anaesthesiology and Critical care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  8210370958  
Fax    
Email  sabahattazeen73@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh, 202002, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical careJawaharlal Nehru Medical College AMU 
Address  Department of Anaesthesiology and Critical care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh, 202002, Uttar Pradesh, India 
Type of Sponsor  Government 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 Sabahat Tazeen  Jawaharlal Nehru Medical College  Department of Anaesthesiology and Critical care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh,202002
Aligarh
UTTAR PRADESH 		 8210370958

sabahattazeen73@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Family Members of adult patients admitted to the ICU 
 
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  Family members of patients admitted to the ICU for at least 48 hours,
Patient admitted to adult ICU
 
 
ExclusionCriteria 
Details  Family member of age less than 18 years,Patient admitted to paediatric ICU,Cognitive impairment or communication difficulties in family member,Patient discharged or died within 48 hours of ICU admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Family satisfaction with the quality of care in ICU  After 48 hours of admission to ICU 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of anxiety and depression in patient attendants  After 48 hours of admission to ICU 
 
Target Sample Size   Total Sample Size="318"
Sample Size from India="318" 
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)   01/08/2025 
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="2"
Months="0"
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   The study will assess the quality of care provided in the adult ICUs of a tertiary care government hospital based on the satisfaction of family members of ICU patients with the care provided to their patients .To calculate the satisfaction level of family members the standard FS-ICU 24 questionnaire will be used.The study will be conducted on all consenting primary caregivers of patients admitted to the Intensive care units 48 hours after admission to give them sufficient time to assess the quality of care being provided.Responses to the standard questions will be recorded on a Likert scale from 1-5 with 1 being poor and 5 being excellent. Result will be calculated under FS-Care and FS-Decision making subscales and total score will also be calculated.The FS-Care result will assess the family satisfaction with the care provided and the FS-Decision making result will assess the family satisfaction with their involvement in decision making for the patient. 
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