| CTRI Number |
CTRI/2024/05/068203 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey Questionaire |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check if patient family members are adequately counselled about patient by the physician in Intensive care unit |
|
Scientific Title of Study
|
A Questionnaire-based study to analyse factors influencing quality and adequacy of communication between the treating physician and family members in an Intensive care unit of a tertiary care hospital |
| 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 Abhiruchi Patki |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dept of Anaesthesia and Intensive care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9177909339 |
| Fax |
|
| Email |
abhiruchipatki2204@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhiruchi Patki |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dept of Anaesthesia and Intensive care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9177909339 |
| Fax |
|
| Email |
abhiruchipatki2204@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Kavitha |
| Designation |
Additional Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Dept of Anaesthesia and Intensive care
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
8143769301 |
| Fax |
|
| Email |
drkarunya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute Of Medical Sciences
Punjagutta, Hyderabad |
|
|
Primary Sponsor
|
| Name |
Nizams Institute of Medical Sciences |
| Address |
Nizams Institute of Medical Sciences, Punjagutta, Hyderabad |
| 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 Sisira |
Nizams Institute of Medical Sciences |
Respiratory Intensive care Unit,
Dept of Anesthesia and Critical Care,
Nizams Institute of Medical sciences,
Punjagutta
Hyderabad
Hyderabad
TELANGANA |
9966993959
sisirapathuri4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Family members of any adult patient admitted in ICU
2. Who had attended atleast 80% of counselling sessions in their vernacular language |
|
| ExclusionCriteria |
| Details |
Unwillingness to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To find correlation between family satisfaction score and socio-demographic attributes of the family member of the discharged survivor of ICU patients
|
At the time of discharge from ICU or death
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find association between components of questionnaire and socio-demographic attributes of the respondents |
At the time of discharge from ICU |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/06/2024 |
| 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="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
|
A previously refined and validate Family Satisfaction in ICU(FS- ICU) survey Questionnaire which consists of 12 questions with 5 point scale each will be filled by one legally responsible close family member of the ICU patient who is willing to participate on request, at the time of discharge for both survivors and non- survivors. A correlation between family satisfaction score and demographic and social factors of both the patient and family member will be assessed for an association. |