| CTRI Number |
CTRI/2025/07/090178 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse- led home care package for caregivers of pediatrics IBD patients ] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessing the effectiveness of A nurse led home care package for caregivers of children with inflammatory bowel disease to improve knowledge and support. |
|
Scientific Title of Study
|
A Quasi-experimental study to assess the effectiveness of A nurse-led home care
package for caregivers of children with Inflammatory Bowel Disease on selected outcome
variables attending Gastroenterology Department at APC, PGIMER, Chandigarh, 2024-26.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Yadav |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
| Address |
M.Sc. Nursing (Pediatric Speciality), Department of Nursing, National Institute of Nursing Education, PGIMER, CHANDIGARH
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08307376920 |
| Fax |
|
| Email |
mansiravi27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Rupinder Kaur |
| Designation |
Tutor at the Department of Nursing |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
| Address |
Room no. 131, Department of Nursing, National Institute of Nursing Education, PGIMER, CHANDIGARH
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878033748 |
| Fax |
|
| Email |
kauramanjot40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Yadav |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH |
| Address |
M.Sc. Nursing (Pediatric Speciality), Department of Nursing, National Institute of Nursing Education, PGIMER, CHANDIGARH
Chhandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08307376920 |
| Fax |
|
| Email |
mansiravi27@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mansi |
| Address |
National Institute of Nursing Education, PGIMER, CHANDIGARH, Pincode160012 |
| 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 |
| Dr Sadhna Bhasin Lal |
Advanced pediatric center, PGIMER, CHANDIGARH |
Room no. 4412, 4th floor, D block, Gastrointestinal department, Advanced pediatrics center, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH |
08307376920
mansiravi27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Intramural), PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K50-K52||Noninfective enteritis and colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led home care package for caregivers of pediatrics IBD patients |
Importance of home care management, Understanding Inflammatory bowel disease,( Definition, etiology) monitoring symptoms, diagnosis, management, Preventive measures, Lifestyle modifications, Psychological support, Administration and adherence, Diet and nutrition, Complications, extraintestinal complications.
Estimated total duration of intervention is 5 months approx. As the subject enrollment and follow up of process is from July to November. |
| Comparator Agent |
Routine care |
Aimed at managing symptoms, promoting growth and development, preventing complications and improving quality of life |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children’s aged (6 months to 18 years) diagnosed with Inflammatory Bowel disease and their caregivers willing to
participate in the study.Participants who are able to understand and speak English,Hindi,
Punjabi |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related Quality of Life for Children having inflammatory bowel disease |
1 week and 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health related quality of life of caregivers of children having Inflammatory bowel disease |
1week and 2 weeks |
• Adherence to treatment regimen
• Child’s gastrointestinal symptoms
• Child’s nutritional status, growth and development
• Complications due to diseased condition
Of Caregiver’s :-
• Quality of life for caregivers
• Caregiver stress, anxiety and Depression
• Coping strategies among caregiver
|
1 week and 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2025 |
| Date of Study Completion (India) |
06/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/12/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 about assessing the effectiveness of a nurse led home care package for the caregivers of children with inflammatory bowel disease. Primary outcome of the study is to improve the health related quality of life of children’s and caregivers by using nurse led package as a tool. This nurse led package includes information about Inflammatory bowel disease, it’s monitoring symptoms, diagnosis, management, Preventive measures, lifestyle modification, psychological support, medication administration and adherence and diet and nutrition. |