Family Members of the PatientsNCT05073341
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
A study testing Nurse-led family intervention in people with Family Members of the Patients, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Family Members of the Patients
- What is being tested?
- Nurse-led family intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary caregivers of CLD patient's understand hindi and english duration of hospitalization more than 6 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 11070
Tarika Sharma, MSc, 01146300000, tarikasharma91@gmail.com
About this study
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
Read the 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
- Conditions
- Family Members of the Patients
- Being tested
- Nurse-led family intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led family interventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| experimental and control group and intervention is given in the experimental group | Experimental | Nurse-led family intervention is given in the experimental group having three components i.e infarmation about the patient condition , guidance, and emotional support Receives: Other: Nurse-led family intervention |
| control group | Other | No intervention will be given in the control group Receives: Other: Nurse-led family intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Nov 2021
- Primary completion1 Oct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Members of the PatientsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi experimental design
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073341
- Sponsor's protocol ID
- ILBS-CLD-01
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05073341
- Acronym / sponsor ID
- ILBS-CLD-01
- Conditions
- Family Members of the Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi experimental design
| Arm | Type | Receives |
|---|---|---|
| experimental and control group and intervention is given in the experimental group | Experimental | Other: Nurse-led family interventionNurse-led family intervention is given in the experimental group having three components i.e infarmation about the patient condition , guidance, and emotional support |
| control group | Other | Other: Nurse-led family interventionNo intervention will be given in the control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary caregivers of CLD patient's understand hindi and english duration of hospitalization more than 6 hours
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led family interventionNurse-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 | Other | control group, experimental and control group and intervention is given in the experimental group |
Primary outcome
to reduce stress, increase satisfaction and increse the engagement with patient care
Time frame: one month data collection
stress will be reduced by giving guidance and emotional support and infarmation about their patient condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led family intervention in people with Family Members of the Patients, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chavvi Bhardwaj, BSc (8826682920, chhavibhardwaj33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to reduce stress, increase satisfaction and increse the engagement with patient care (time frame: one month data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.