| CTRI Number |
CTRI/2022/01/039079 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Family satisfaction in intensive care unit(ICU) care and their decision making among family members of critically ill patients - A cross sectional survey |
|
Scientific Title of Study
|
Family satisfaction with intensive care unit (ICU) care and their involvement in decision making among family members of critically ill patients in ICU’s of selected hospital of Udupi District- A cross sectional survey |
| Trial Acronym |
FS-ICU |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Jyothi Marakalthi |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing
Manipal Academy of Higher Education(MAHE)
Manipal
Karnataka
India-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9535797947 |
| Fax |
|
| Email |
jyothisuvarna195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDaisy J Lobo |
| Designation |
Associate Professor and guide |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
MAHE Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
|
| Email |
daisy.j@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daisy J Lobo |
| Designation |
Associate Professor and Guide |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal College of Nursing Manipal
MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
|
| Email |
daisy.j@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mrs Jyothi Marakalthi |
| Address |
Manipal College of Nursing Manipal
MAHE Manipal- 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDaisy J Lobo |
Kasturba Hospital Manipal |
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA |
9535687697
daisy.j@manipal.edu |
| Jyothi Marakalthi |
Kasturba Hospital Manipal |
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA |
9535797947
jyothisuvarna195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The adult family members of patients admitted to ICU for more than or equal to 48hrs
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Family members of adult patients admitted to the ICU for equal or more than 48hrs
2)Age more than 18yrs of family member
3)One family member per patient can participate |
|
| ExclusionCriteria |
| Details |
1)Not willing to participate
2)Age less than 18yrs of the family member
3)Patients who died or discharged within 48hrs of admission
4)Cognitive impairment in the participant
5)Pediatric patient family members
6)Unable to read or write Kannada/ English |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be significant association between family satisfaction with ICU care and involvement in decision making |
During discharge from the ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the predictors of family satisfaction with ICU care and involvement in decision making |
During discharge from the ICU |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
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)
|
03/01/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A cross sectional survey to assess family satisfaction with ICU care and their involvement in decision making among family members of critically ill patients in ICUs of selected hospital of Udupi District. The study findings would help to identify opportunities for improvement in family satisfaction with ICU care and decision making. |