| CTRI Number |
CTRI/2024/12/077536 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to observe the perception of families and caregivers of patients with substance use disorder in the Intensive Care Unit : A Qualitative Analysis |
|
Scientific Title of Study
|
Perception of families and caregivers of patients with substance use disorder in the Intensive Care Unit : A Qualitative Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rubina Khullar Mahajan |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of critical care medicine, Dayanand Medical College and hospital, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9779497705 |
| Fax |
|
| Email |
Khullar.rubina@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jasmine Kaur Kochhar |
| Designation |
Senior Resident |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of critical care medicine, Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9478804850 |
| Fax |
|
| Email |
jasminekochhar123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasmine Kaur Kochhar |
| Designation |
Senior Resident |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of critical care medicine, Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9478804850 |
| Fax |
|
| Email |
jasminekochhar123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana, 141001, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Rubina Khullar Mahajan |
| Address |
Dayanand Medical College and Hospital, Ludhiana, 141001, Punjab, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jasmine Kaur Kochhar |
Dayanand Medical College and Hospital, Ludhiana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rubina Khullar Mahajan |
Dayanand Medical College and Hospital, Ludhiana |
Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB |
9779497705
Khullar.rubina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Family members of patients with substance use disorders admitted in ICU, and ICU caregivers who have been taking care of addicted patients for more than 24 hours. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult family members (first-of-kin) of patient with substance use disorder who is admitted to ICU for more than 24 hours.
2. ICU Caregivers (staff nurses and trainee doctors) who have been taking care of addicted patient for more than 24 hours. |
|
| ExclusionCriteria |
| Details |
1. Refusal to consent for the interview or participate in the study.
2. Patients who are discharged from ICU within 24 hours.
3. Critically ill patients on high ventilatory and vasopressor support. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the perceptions and challenges faced by the families and ICU personnel taking care of addicted patients admitted to ICU. |
after 24 hours of admission in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To acknowledge their ideas and thus formulate suggestions which may contribute to a better care of these patients, families and caregivers. |
after 24 hours of admission in ICU |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/12/2024 |
| 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="0"
Months="2"
Days="15" |
|
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
|
Substance abuse is a very common problem and many patients who are admitted to the ICU are suffering from substance abuse disorder. Numerous studies have been conducted on the patients with substance use disorder who require hospital admission but there are very few studies on the perceptions and needs of the family and the caregivers when these patients require ICU care. Through this study, we plan to explore and understand the impact, on the stakeholders, of having patients with addiction problems under their care and subsequently formulate ideas to improve treatment outcomes and quality of care of these patients. |