| CTRI Number |
CTRI/2025/05/087065 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of a structured education program on health related outcomes for patients underwent valve replacement surgeries |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of a discharge preparedness program on health related outcomes of patients undergoing valve replacement surgeries at PGIMER Chandigarh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bandna Kumari |
| Designation |
PhD Scholar |
| Affiliation |
PGIMER Chandigarh |
| Address |
House.no.765, phase 6 mohali punjab
CTVS ICU, 4 th floor, D block, advanced cardiac centre PGIMER Chandigarh
Rupnagar
PUNJAB
160055
India |
| Phone |
8437326926 |
| Fax |
|
| Email |
bandna76pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhpal kaur |
| Designation |
Principal and head at national Institute of nursing education PGIMER Chandigarh |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room no. 201, ground floor, national Institute of nursing education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drsukhpalkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bandna Kumari |
| Designation |
PhD Scholar |
| Affiliation |
PGIMER Chandigarh |
| Address |
CTVS ICU, fourth floor, D block, advanced cardiac centre, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437326926 |
| Fax |
|
| Email |
bandna76pgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of nursing education,Post graduate institute of medical education and research Chandigarh, India, pin code 160012 |
|
|
Primary Sponsor
|
| Name |
Bandna Kumari |
| Address |
Nursing officer, CTVS ICU, 4 th floor, advanced cardiac centre, PGIMER Chandigarh |
| 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 |
| Bandna kumari |
Post graduate Institute of medical education and research Chandigarh India |
Room no. 1015 (CTVS OPD) and CTVS ward 4 th floor, A block, advanced cardiac centre
Chandigarh
CHANDIGARH |
8437326926
bandna76pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
Routine discharge process without specialised training for self and home care |
| Intervention |
Structured education program |
Orientation and training of patients and caregivers about self and home care, informational booklet( in Hindi, English and Punjabi) as per the understanding level of patients, periodic motivation of the patients for adherence to therapeutic regimen, post discharge monitoring via physical or telephonic follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who received mechanical heart valves |
|
| ExclusionCriteria |
| Details |
Patients with congenital valvulopathies
Patients underwent CABG or any other repair along with valve replacement surgeries
Patients with transcatheter valve replacement
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No of hospitalizations due to post operative complications |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of morbidity and mortality after one year of discharge from the hospital, quality of life, adherence to medications, self management |
Within one year of discharge |
|
|
Target Sample Size
|
Total Sample Size="123"
Sample Size from India="123"
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)
|
01/06/2025 |
| 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="15"
Months="1"
Days="3" |
|
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 randomised control trial aims to evaluate the effectiveness of a structured education program regarding discharge preparedness of patients underwent valve replacement surgery attending a tertiary level Institute on health related outcomes. The enrolment of patients supposedly begins in first week of may and trial would finish in August 2026. |