| CTRI Number |
CTRI/2023/12/060919 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Caregiver burden among informal caregivers of hemodialysis patients in selected private hospitals of Udupi district |
|
Scientific Title of Study
|
A study to assess the caregiver burden among the informal caregivers
of hemodialysis patients in selected private hospitals situated in Udupi district: A Mixed method
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 |
Shravya L Nayak |
| Designation |
II year MPH Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Master of Public Health student
Department of Health Policy
Room Number 52
Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8495033433 |
| Fax |
|
| Email |
nayak.shravya27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Prasanna School of Public Health |
| Address |
Assistant Professor Senior Scale
Room Number 52
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8904569460 |
| Fax |
|
| Email |
vidya.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
Prasanna School of Public Health |
| Address |
Assistant Professor Senior Scale
Room Number 52
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8904569460 |
| Fax |
|
| Email |
vidya.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Prasanna School of Public Health Manipal Udupi district |
|
|
Primary Sponsor
|
| Name |
Shravya L Nayak |
| Address |
Master of Public Health student
Room Number 52
Department of Health Policy
Prasanna School of Public Health
Manipal Academy of Higher Education
Manipal
Udupi district
576104 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Shravya L Nayak |
Prasanna School of Public Health |
Department of
Health Policy Room Number 52
Prasanna School of Public Health Manipal Academy of
Higher Education
Udupi
KARNATAKA
576104
Udupi
KARNATAKA |
8495033433
nayak.shravya27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of Hemodialysis patients |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Informal caregivers of patients who are receiving hemodialysis treatment for more
than 3 months of period and aged 18 years and above
Participants who are informal caregivers of hemodialysis patients who are receiving
hemodialysis on an outpatient basis
Participants were informal caregivers of hemodialysis patients who are visiting the
hospital for follow-up consultation |
|
| ExclusionCriteria |
| Details |
Caregivers who are on medication with psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will Identify the amount of care burden and determine sociodemographic
characteristics that influence the level of care burden |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to provide insight into understanding difficulties experienced by informal
caregivers of hemodialysis patients |
6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "186"
Final Enrollment numbers achieved (India)="186" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
22/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective cross-sectional study, conducted from January to June 2024, aims to delve into the caregiver burden and challenges faced by informal caregivers of hemodialysis patients in selected private hospitals within the Udupi district. To estimate caregiver burden the research encompasses a sample size of 186 to collect quantitative data by using the Zarit Burden Interview (ZBI) tool and Modified Kuppuswamy socioeconomic scales. To comprehensively grasp the challenges faced by caregivers, employ in-depth interviews by using a validated in-depth interview guide and continue until data saturation occurs. Informal caregivers, defined as individuals providing unpaid assistance with daily living activities to those with chronic illnesses, are included based on specific criteria. The research objectives include estimating caregiver burden, determining its association with sociodemographic characteristics, and exploring the challenges faced by caregivers. Specific inclusion and exclusion criteria are outlined, focusing on informal caregivers of hemodialysis patients undergoing outpatient treatment for over three months. The anticipated outcomes involve identifying the levels of caregiver burden and sociodemographic factors influencing it, as well as gaining insight into the difficulties experienced by informal caregivers of hemodialysis patients. The findings are expected to inform interventions and support strategies to alleviate caregiver burden and enhance the overall well-being of this critical demographic. |