| CTRI Number |
CTRI/2025/12/099140 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development and Validation of a Tool to Measure Knowledge, Attitude, and Readiness for Phase II Cardiac Rehabilitation |
|
Scientific Title of Study
|
Validation of a Questionnaire on Knowledge, Attitude and Readiness for phase 2 cardiac rehabilitation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogeetha K |
| Designation |
Post-graduate student |
| Affiliation |
Sri Ramachandra Institute of Education And Research |
| Address |
Sri Ramachandra Faculty of physiotherapy,SRIHER,porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9840952435 |
| Fax |
091-44-24765995 |
| Email |
yogi472001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrT Senthil Kumar |
| Designation |
Associate Professor and Head, Department of Cardiopulmonary Physiotherapy |
| Affiliation |
Sri Ramachandra Institute of Education And Research |
| Address |
Sri Ramachandra Faculty of physiotherapy,SRIHER,porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444368189 |
| Fax |
|
| Email |
senthilkumar.t@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrT Senthil Kumar |
| Designation |
Associate Professor and Head, Department of Cardiopulmonary Physiotherapy |
| Affiliation |
Sri Ramachandra Institute of Education And Research |
| Address |
Sri Ramachandra Faculty of physiotherapy,SRIHER,porur Chennai
Sri Ramachandra Faculty of physiotherapy,SRIHER,porur Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444368189 |
| Fax |
|
| Email |
senthilkumar.t@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yogeetha K |
| Address |
Sri Ramachandra Faculty of physiotherapy,SRIHER,porur Chennai |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Yogeetha K |
Sri Ramachandra Medical Centre |
Sri Ramachandra Faculty of physiotherapy,SRIHER,porur Chennai
Chennai
TAMIL NADU |
9840952435
yogi472001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional Ethics Committee, SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above,
Patients diagnosed with heart disease (e.g., heart attack, bypass surgery) and referred for
Phase II cardiac rehabilitation,
Patients who are clinically stable and able to answer the questionnaire. |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate or who provide incomplete questionnaire responses,
Those who refused to complete questionnaire,
Questionnaires with incomplete responses or missing key information,
Patients with severe cognitive or psychiatric issues that prevent answering the
questionnaire,
Patients with serious physical disabilities or unstable conditions (e.g., worsening heart
failure) that make exercise unsafe. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the content validity of the questionnaire assessing knowledge attitude and readiness for Phase II cardiac rehabilitation through expert evaluation. |
1 WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the clarity & readability of each questionnaire item based on expert feedback.
To identify items that need modification removal or addition to improve the overall questionnaire quality.
To finalize a validated questionnaire suitable for assessing knowledge attitude & readiness for Phase II cardiac rehabilitation. |
1 WEEK |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
30/12/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to validate a questionnaire that measures the knowledge attitude and readiness for Phase II cardiac rehabilitation among cardiac patients. Phase II cardiac rehabilitation is an important part of recovery after discharge and patients need to have proper understanding and motivation to participate in the program. A valid questionnaire will help assess these factors correctly. In this study the questionnaire will be reviewed by five subject experts to check its clarity relevance and accuracy. The experts will evaluate each item and suggest changes wherever needed. Their feedback will be used to refine and finalize the questionnaire. The validated questionnaire will help healthcare professionals understand the patients level of knowledge attitude and readiness for Phase II cardiac rehabilitation and support better patient education and improved participation in the program. |