| CTRI Number |
CTRI/2024/01/061160 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Socio-economic implications on family and health related quality of life among ICU survivors |
|
Scientific Title of Study
|
Assessment of socio-economic implications on family and health related quality of life among intensive care unit survivors of a combat tertiary care hospital in India: A 6 month follow-up 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 |
Nitin Pahuja |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital/Armed Forced Medical College, Pune |
| Address |
Department of Anaesthesia and Critical Care,
Command Hospital, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9876087985 |
| Fax |
|
| Email |
pb_nitin@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Pahuja |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital/Armed Forced Medical College, Pune |
| Address |
Department of Anaesthesia and Critical Care,
Command Hospital, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9876087985 |
| Fax |
|
| Email |
pb_nitin@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Pahuja |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital/Armed Forced Medical College, Pune |
| Address |
Department of Anaesthesia and Critical Care,
Command Hospital, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9876087985 |
| Fax |
|
| Email |
pb_nitin@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Command Hospital |
| Address |
Command Hospital, Pune |
| 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 Nitin Pahuja |
Command Hospital, Pune |
ICU-A, Department of Anaesthesia and Critical Care, Block-3, Floor-5
Pune
MAHARASHTRA |
9876087985
pb_nitin@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Armed Forces Medical College, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z636||Dependent relative needing care athome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
12 years or older
Duration of ICU stay more than 48 hours
Requirement of mechanical ventilation and/or inotropic support during ICU stay
Expected survival time greater than 3 months post-ICU discharge as estimated by intensivists |
|
| ExclusionCriteria |
| Details |
Less than 12 years of age
Patients with pre-existing psychiatric disorders
Patients dependent on others for activities of daily living prior to current hospitalization
Unable or unwilling to give consent
No social support at home
Expected survival time less than 3 months post-ICU discharge as estimated by intensivists |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of socio-economic implications on family and health related quality of life among intensive care unit survivors |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
11/01/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
With advances in medical technology, the care provided by intensive care units has improved a lot. This is reflected as increase in survival rate of ICU patients. Despite reduction in mortality, a significant number of ICU survivors suffer from cognitive, physical and mental impairments. These impairments are also labelled as post-intensive care syndrome. Though there is very scarce epidemiological data it is estimated that 50% or more of ICU survivors suffer from one or more of its components. These impairments are associated with reduced health related quality of life of survivors and have impact on resuming independent living and employment. Further they may be socio-economic consequences on the patients as well as their immediate families. Covinsky et al followed patients for a year who were discharged after hospitalization with some serious illness. They observed that 34% of the patients required considerable care giving assistance. In 20% of the cases. a family member had to leave work and a third of families reported a loss of major source of income. Loss of employment of one or other family members along with consequential requirement for care may jeopardize the family social and economic stability. There are reports of family members experiencing stress and negative health outcomes themselves. As combat hospitals provide free of cost medical services to the entitled patients, it is assumed that it does not impose any financial burden on the serving personnels or exservicemen and their families. However the socio-economic impact of critical illnesses on survivors and their families on ground is largely un-determined. Majority of the serving combat personnels are posted in far-lying areas and are staying away from the family which usually includes dependent elderly parents, spouse and children. They may have non-dependent brothers, sisters or some other relatives who are looking after their families in their absence. It happens a number of times that despite some serious medical condition of a family member, they are not able to visit them or visit them for only a brief period of time due to service contingencies/ organisation requirements. Further the dependents may not be able to avail medical services for follow-up in service hospitals which may be due to many factors like service hospitals are at considerable distance from their residence, non-availability of transport or some accompanying personnel. Many times, some family members lose employment or have to leave the job to look after the survivor or there is need to hire some care-giver. These factors in combination may have profound socio-economic implications on family and health related quality of life of survivors. To date, there have been limited attempts to estimate the magnitude of this issue. The present cohort study aims at assessing the socio-economic implications on family using a novel question set designed to assess the changes and health related quality of life using a Short Form-12 self-report questionnaire among intensive care unit survivors of a combat tertiary care hospital in India.
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