| CTRI Number |
CTRI/2025/08/093497 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse-led empowerment program for family caregivers of palliative care patients] |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Nurse Support to Reduce Stress and Improve Life for Families Caring for Seriously Ill Patients |
|
Scientific Title of Study
|
Effectiveness of a Nurse-Led Empowerment Programme in Reducing Burden and Promoting Health-Related Quality of Life among Family Caregivers of Palliative Care Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJU RAM PARIHAR |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9414560502 |
| Fax |
|
| Email |
raju.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Professor and Superviser |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Room No 109, Ground Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Parihar |
| Designation |
Associate Professor |
| Affiliation |
Govt College of Nursing, Jodhpur |
| Address |
Room No 14, Ground floor, south wing, Govt College of Nursing, Dr S N Medical College, Jodhpur
Jodhpur
RAJASTHAN
342007
India |
| Phone |
9529794077 |
| Fax |
|
| Email |
mamtaparihar2011@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raju Ram Parihar |
| Address |
PhD Section, Ground Floor, Teerthanker Mahaveer College of Nursing, Teerthanker Mahaveer University, NH-24, Bagarpur, Delhi Road, Moradabad |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Raju Ram Parihar |
Palliative Care Centers in Jodhpur District |
community/home-based data collection in Jodhpur District
Jodhpur
RAJASTHAN |
9414560502
raju.scholar@tmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, TEERTHANKER MAHAVEER DENTAL COLLEGE & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress and reduced well-being in primary family caregivers of palliative care patients (ICD-10 Code: Z63.6 – Dependent relative needing care at home) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led Empowerment Programme |
The support programme includes educational sessions, emotional support, self-care strategies, and guidance aimed at improving caregiving skills and overall well-being. The total duration of the programme will be 1.5 years. |
| Comparator Agent |
Routine Support |
Family caregivers will receive the usual guidance and informal support typically provided as part of standard care. The total duration of the programme will be 1.5 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Primary family caregivers providing informal care to palliative care patients with advanced oncological or non-oncological pathologies and managing care for more than 4 hours a day.
Proficiency in Hindi/English languages used for program communication and assessment.
Willingness to provide informed consent to participate in the study.
Availability to attend program sessions and complete follow-up assessments as required. |
|
| ExclusionCriteria |
| Details |
Formal/Informal caregivers who receive financial compensation.
Primary family caregivers who are not directly involved in the care of palliative care patients.
Family caregivers with cognitive or psychiatric disorders that would hinder their participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in caregiver burden measured using Zarit Burden Interview (ZBI) and Improvement in health-related quality of life measured using WHOQOL-BREF scale |
Baseline, 2 weeks after intervention, and 6 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/09/2025 |
| 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="6"
Days="0" |
|
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
|
This study is a non-rendemised control trial with the aims to find out whether a support program led by nurses can help reduce stress and improve the well-being of primary family caregivers who are taking care of seriously ill or palliative care patients at home. The support program includes education, emotional support, and practical caregiving guidance. The study will measure changes in caregiver burden and quality of life before and after the program. We hypothesize that the nurse-led intervention will reduce caregiver burden and improve overall health-related quality of life. |