| CTRI Number |
CTRI/2025/05/086096 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Nurse- led intervention program for patients undergoing kidney transplant |
|
Scientific Title of Study
|
Impact of Nurse- led intervention program on selected outcome variables among patients undergoing renal transplant: a mixed methods 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 |
Neha Handa |
| Designation |
PhD Scholar |
| Affiliation |
PGIMER |
| Address |
Room No. 209, Department of National Institute of Nursing Education, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7837802341 |
| Fax |
|
| Email |
handa.neha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Dutta |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Room No. 120, National Institute of Nursing Education, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Dutta |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Room No. 120, National Institute of Nursing Education, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872528465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh 160012, India |
|
|
Primary Sponsor
|
| Name |
Neha Handa |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh 160012, India |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| Neha Handa |
PGIMER |
Room No. 4020, Renal Transplant Surgery areas, Department of Renal Transplant Surgery
Chandigarh
CHANDIGARH |
7837802341
handa.neha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Routine care |
| Intervention |
Nurse- led Intervention Program |
Total duration of the intervention- 3 months. This will include Information booklet, Video clips, Demonstrations related to post renal transplant care, Follow up till 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Immediate post-transplant patients
|
|
| ExclusionCriteria |
| Details |
Dual transplant
Second transplant
Age less than 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Readmission rate |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Adherence
- Unmet care needs
- Health related quality of life
- Kidney recipients’ transplant knowledge
- Patient satisfaction
- Knowledge of caregivers
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
19/05/2025 |
| 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="2"
Months="0"
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 is a mixed methods study. The objectives of this trial includes 1. To perform situational analysis of Renal Transplant Surgery areas, PGIMER, Chandigarh in context to post transplant care. 2. To develop and validate Nurse- led intervention program for patients in Renal Transplant Surgery areas, PGIMER, Chandigarh. 3. To implement and assess the effectiveness of Nurse- led intervention program on selected outcome variables among patients in Renal Transplant Surgery areas, PGIMER, Chandigarh. |