| CTRI Number |
CTRI/2024/06/068532 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A scientific study to examine the practicability and impact of care provided by close family members in addition to conventional care provided by doctors and nurses inside the Intensive care unit |
|
Scientific Title of Study
|
Feasibility and impact of the Home in ICU concept, an interventional pilot study in a tertiary care medical college hospital of Eastern India |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kondala Swathi |
| Designation |
DM resident |
| Affiliation |
IMS and SUM Hospital |
| Address |
Department of Critical Care Medicine, Institute of Medical Sciences and SUM Hospital, K8 Kalinganagar, PO-Gatikia, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
8143823445 |
| Fax |
|
| Email |
swathiomc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sanghamitra Mishra |
| Designation |
Dean and professor |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Office of the Dean, Institute of Medical Sciences and SUM Hospital, K8 Kalinganagar, PO-Gatikia, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
7381177222 |
| Fax |
|
| Email |
dean.ims@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kondala Swathi |
| Designation |
DM resident |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Department of Critical Care Medicine, Institute of Medical Sciences and SUM Hospital, K8 Kalinganagar, PO-Gatikia, Bhubaneswar, Odisha
Khordha
ORISSA
751003
India |
| Phone |
8143823445 |
| Fax |
|
| Email |
swathiomc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kondala Swathi |
| Address |
H.No 1-52/1/225, Bhavanipuram Colony,Chandanagar, Hyderabad-500050 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kondala Swathi |
Institute of Medical Sciences and SUM Hospital |
Department of Critical Care Medicine, first floor, Medical Intensive Care Unit 1, Institute of Medical Sciences and SUM Hospital, K8 Kalinganagar, PO-Gatikia, Bhubaneswar
Khordha
ORISSA |
8143823445
swathiomc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Biomedical and Human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z741||Need for assistance with personalcare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Care |
Patient relatives to be allowed bedside in ICU only during visiting hours |
| Intervention |
Home in ICU Care |
Patient relatives/ close family members allowed by patients bedside |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
For patients
1.Willing to participate in the study
2.Conscious, alert, and able to communicate
For family members
1.Close family member
2.The patient is willing for the family member to stay with them
3.Sensible and effective
4.Emotionally stable
5.Willing to participate in the study
6.Trained in ‘Home in ICU’ care
7.Willing to stay for at least 7 days during ICU stay with the patient after training and assessment
For healthcare team
1.Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Diagnosed with a serious airborne contagious disease (Covid 19, H1N1)
2. Anybody who is not meeting the inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Feasibility
Patient satisfaction during ICU stay whenever possible
ICU length of stay
Presence or absence of delirium
Occurrence of near-miss events during ICU stay
Post-discharge cognition impairment using BASIC- Q scoring system
Occurrence and severity of bedsore
ICU-acquired infections |
Feasibility - ICU discharge
Patient satisfaction during ICU stay whenever possible- Daily
ICU length of stay- ICU discharge
Presence or absence of delirium- 8th hrly
Occurrence of near-miss events during ICU stay- Daily
Post-discharge cognition impairment using BASIC- Q scoring system - Day 28
Occurrence and severity of bedsore -daily
ICU-acquired infections- daily |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence & level of burnout symptoms & workload among nurses & doctors using questionnaires
Close family members satisfaction levels using questionnaires
Time to ask for consent & the time to obtain consent for regular ICU-related procedures
Additional health-related information about the patient |
Incidence & level of burnout symptoms & workload among nurses & doctors using questionnaires - daily
Close family members satisfaction levels using questionnaires - daily
Time to ask for consent & the time to obtain consent for regular ICU-related procedures – during the procedure
Additional health-related information about the patient - every shift |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2024 |
| Date of Study Completion (India) |
31/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/08/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study is a single-centered non-randomized interventional pilot trial to assess the feasibility of practicing the ‘home at ICU’ concept and its superiority over conventional intensive care. The primary outcome measures will be the feasibility of the ’Home in ICU’ care, ICU length of stay, and the presence of delirium on admission, during ICU stay, and at discharge. Also, bedsores and ICU-acquired infections at discharge will be noted. The secondary outcome will be burnout symptoms, workload among nurses and doctors, and patient well-being assessed using questionnaires. Others will be incidences of near-miss events, time taken to ask for consent, and time to obtain consent. |