| CTRI Number |
CTRI/2025/04/085333 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
effectiveness of theory based nursing intervention on self care ability,health literacy and clinical outcome among post coronary angioplasty patient |
|
Scientific Title of Study
|
A Quasi experimental study to assess the effectiveness of Orems self care theory based nursing interventional pathway on self care ability, health literacy and clinical outcomes among post percutaneous coronary intervention (PCI) patients in Coronary Care Unit (CCU), AIIMS New Delhi. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandhya Verma |
| Designation |
PG STUDENT |
| Affiliation |
AIIMS NEW DELHI |
| Address |
COLLEGE OF NURSING AIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
09650875387 |
| Fax |
|
| Email |
sandhyaverma1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SMITA DAS |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
COLLEGE OF NURSING AIIMS DELHI |
| Address |
FIRST FLOOR, COLLEGE OF NURSING OLD OT BLOCK AIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
9871755975 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SMITA DAS |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
COLLEGE OF NURSING AIIMS DELHI |
| Address |
FIRST FLOOR, COLLEGE OF NURSING OLD OT BLOCKAIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
9871755975 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
|
Source of Monetary or Material Support
|
| COLLEGE OF NURSING, AIIMS NEW DELHI, ANSARI NAGAR DELHI 110029 INDIA |
|
|
Primary Sponsor
|
| Name |
SANDHYA VERMA |
| Address |
COLLEGE OF NURSING, AIIMS NEW DELHI,ANSARI NAGAR NEW DELHI 110029 INDIA |
| 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 |
| SANDHYA VERMA |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES , NEW DELHI |
CT2 CCU SECOND FLOOR CARDIONEURO CENTER
South
DELHI |
9650875387
sandhyaverma1011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OREMS SELFCARE BASED NURSING INTERVENTIONAL PATHWAY FOR POST CORONARY ANGIOPLASTY PATIENTS |
AFTER CORONARY ANGIOPLASTY PATIENTS WILL RECEIVE NURSING CARE BASED ON OREMS SELF CARE THEORY WHICH INCLUDES WHOLLY COMPENSATORY,PARTLY COMPENSATORY AND SUPPORTIVE EDUCATIVE MODEL AND AT THE TIME OF DISCHARGE, DISCHARGE TEACHING WILL BE GIVEN BY RESEARCHER |
| Comparator Agent |
ROUTINE POST CORONARY ANGIOPLASTY NURSING CARE |
PATIENT WILL RECEIVE ROUTINE POST CORONARY ANGIOPLASTY NURSING CARE WHICH IS PROVIDED NOW AND THAT IS NOT BASED ON ANY THEORY. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who underwent PCI and
1.Age 18-75 years
2.Able to read and understand Hindi or English
3.Willing to participate in the study
4.Duration of hospital stay greater than 24 hours.
|
|
| ExclusionCriteria |
| Details |
1. PATIENTS WITH SEVERE COMPLICATIONS SUCH AS RENAL FAILURE, HEART FAILURE, ARRYTHMIAS, SHOCK, PULMONARY EDEMA AND MALIGNANCY
2. PATIENTS WITH COGNITION DISORDERS
3. PATIENTS WITH HEARING IMPAIRMENT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.SELF CARE ABILITY
2.HEALTH LITERACY
3.CLINICAL OUTCOMES |
1.SELF CARE ABILITY AT 4 WEEKS
2.HEALTH LITERACY AT BASELINE
3.CLINICAL OUTCOMES AT BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASSOCIATION OF HEALTH LITERACY AND SELF CARE ABILLITY |
AT 4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
INTERVENTIONAL GROUP PATIENTS WILL RECEIVE CARE BASED ON OREM’S SELF CARE NURSING INTERVENTIONAL PATHWAY, AT THE TIME OF DISCHARGE THEIR HEALTH LITERACY AND CLINICAL OUTCOMES WILL BE ASSESSED BY USING STRUCTURED TOOLS AND AFTER 28 DAYS OF THEIR DISCHARGE SELF CARE ABILITY WILL BE ASSESSED.
|