| CTRI Number |
CTRI/2024/06/068618 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Self-care education program ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of self-care education program on Cardiac self-efficacy and Quality of life among patients undergone PTCA |
|
Scientific Title of Study
|
An experimental study to assess the
effectiveness of self-care education programme on cardiac self-efficacy and quality of life of patients
undergone PTCA at selected tertiary care centre, Bhopal, Madhyapradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anurag Bhai Patidar |
| Designation |
Associate professor |
| Affiliation |
Nursing College, Aiims Bhopal |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing, Nursing College, All India Institute of Medical Sciences Bhopal, Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7898105551 |
| Fax |
|
| Email |
anurag.nursing@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Debashmita Sengupta |
| Designation |
M. Sc. Nursing student |
| Affiliation |
Nursing College, Aiims Bhopal |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing, Nursing College, All India Institute of Medical Sciences Bhopal, Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7365875116 |
| Fax |
|
| Email |
debashmitas.mscnuraing23@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Debashmita Sengupta |
| Designation |
M. Sc. Nursing student |
| Affiliation |
Nursing College, Aiims Bhopal |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing, Nursing College, All India Institute of Medical Sciences Bhopal, Saket Nagar, Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7365875116 |
| Fax |
|
| Email |
debashmitas.mscnuraing23@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Aiims Bhopal,Saket Nagar , Bhopal, Madhya Pradesh, India, pin code-462020 |
|
|
Primary Sponsor
|
| Name |
Dr Anurag Bhai Patidar |
| Address |
Department of Cardiological/ Cardiothoracic Vascular Nursing, Nursing College, All India Institute of Medical Sciences Bhopal, Saket Nagar, Bhopal, Madhya Pradesh, India , pin code 462020 |
| 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 |
| Debashmita Sengupta |
AIIMS Bhopal |
Cardiology Ward, Cardiology ICU, Department of Cardiology
Bhopal
MADHYA PRADESH |
7365875116
debashmitas.mscnursing23@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Bhopal Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Care |
This group will receive routine care. No self-care education program will be conducted for the control group. After 30 days, the tailored video will be provided to them. |
| Intervention |
Self-care education program |
Self-care education program comprises of a systematically organized structured discharge teaching using PowerPoint Presentation and tailored video (in hindi). The video will also be provided to the patients,followed by telephonic follow-up (at day
7 and day 12 Post Procedure). The structured discharge teaching & the video will be encompassing five target health
behaviours:
• Smoking cessation
• Heart-healthy diet
• Physical activity
• Medication adherence
• Stress management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than 18 years
2) Primary PTCA
3) Hemodynamically stable
4) Being able to read, write or understand Hindi & English
5) Having access to smart mobile phone
6) Willingness to participate |
|
| ExclusionCriteria |
| Details |
1) Patients diagnosed with any other serious or chronic disease
2) Any sensory impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardiac self-efficacy |
At baseline, day 15, day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life which will be assessed by the Mac New Health related Quality of Life Instrument |
At baseline,day 15 & day 30 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2024 |
| Date of Study Completion (India) |
01/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
Cardiovascular diseases are the leading cause of death globally, claiming
millions of lives each year. Among the various cardiovascular conditions, coronary artery disease (CAD) is particularly prevalent and contributes significantly to the burden of CVD. Percutaneous Transluminal Coronary Angioplasty (PTCA) is an invasive therapeutic intervention designed to treat CAD. Post this intervention, the patients need to revise their health behaviour to adopt to a heart-healthy lifestyle choice. This study aims to assess the effectiveness of self-care education program on cardiac self-efficacy and quality of life among patients undergone PTCA to empower patients to actively participate in their recovery and reduce the risk of reinfarction. |