Back to resultsEffectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi
Primary Purpose
Family Members of the Patients
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nurse-led family intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Family Members of the Patients
Eligibility Criteria
Inclusion Criteria:between age group of 18-65 years
- primary caregivers of CLD patient's understand hindi and english duration of hospitalization more than 6 hours
Exclusion Criteria:
- primary caregivers who cannot understand hindi and english age more than 65 years of age caregivers of patient's who are other than CLD not willing to participate
Sites / Locations
- Institute of Liver & Biliary SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
experimental and control group and intervention is given in the experimental group
control group
Arm Description
Nurse-led family intervention is given in the experimental group having three components i.e infarmation about the patient condition , guidance, and emotional support
No intervention will be given in the control group
Outcomes
Primary Outcome Measures
to reduce stress, increase satisfaction and increse the engagement with patient care
stress will be reduced by giving guidance and emotional support and infarmation about their patient condition
Secondary Outcome Measures
Full Information
NCT ID
NCT05073341
First Posted
October 8, 2021
Last Updated
April 6, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT05073341
Brief Title
Effectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi
Official Title
Effectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quasi experimental study to check the effectiveness of Nurse-led family Intervention on stress, engagement with patient care and satisfaction among primary caregivers of chronic liver disease patients admitted in high depency unit ILBS, two group pre test post test design non randomisation with the Nurse-led family intervention with the sample size of 80 using purposive sampling technique and having independent variable as Nurse-led family intervention and dependent variables are stress, Engagement with patient care and satisfaction and these variables are assesed by using kingston caregivers scale(KCSS) caregiver health engagement scale (CHEW-S)and one knowledge questionnaire based on engagement and satisfaction scale
Detailed Description
study having different inclusion and exclusion for criteria CLD patients and Caregiver sof patint's admitted in HDU inclusion criteria of primary caregivers between the age group of 18-65years understand hindi and english duration of hjospitalization should be more than 6 hours exclusion criteria is primary are givers who cannot understand hindi or english and age more than 65 years of age , craegivers of patients who are having disease other than CLD and those who are not willing to participate inclusion for criteria CLD patients decompensated CLD patients , understand hindi and english , duration of hospitalization more than 6 hours , patient is concious and in semi concious state and patient with hepatic encephlopathy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Family Members of the Patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi experimental design
Masking
None (Open Label)
Masking Description
non randomisation
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental and control group and intervention is given in the experimental group
Arm Type
Experimental
Arm Description
Nurse-led family intervention is given in the experimental group having three components i.e infarmation about the patient condition , guidance, and emotional support
Arm Title
control group
Arm Type
Other
Arm Description
No intervention will be given in the control group
Intervention Type
Other
Intervention Name(s)
Nurse-led family intervention
Intervention Description
Nurse-led family intervention having three components first is infarmation about the patient's condition and guidance will be given to solve there queries and the emotional support will be given to the primary caregivers of CLD patient's admitted in HDU
Primary Outcome Measure Information:
Title
to reduce stress, increase satisfaction and increse the engagement with patient care
Description
stress will be reduced by giving guidance and emotional support and infarmation about their patient condition
Time Frame
one month data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:between age group of 18-65 years
primary caregivers of CLD patient's understand hindi and english duration of hospitalization more than 6 hours
Exclusion Criteria:
primary caregivers who cannot understand hindi and english age more than 65 years of age caregivers of patient's who are other than CLD not willing to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chavvi Bhardwaj, BSc
Phone
8826682920
Email
chhavibhardwaj33@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
11070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarika Sharma, MSc
Phone
01146300000
Email
tarikasharma91@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Nurse-led Family Intervention on Stress, Engagement With Patient's Care and Satisfaction Among Primary Caregivers of Chronic Liver Disease Patients Admitted in High Dependency Unit of ILBS, New Delhi
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