| CTRI Number |
CTRI/2025/11/097267 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of a Structured Patient Education Program on Cardiac Rehabilitation Among Patients With Cardiovascular Disease |
|
Scientific Title of Study
|
Impact of a Structured Patient Education Program on Cardiac Rehabilitation Enrolment Rate Among Patients With Cardiovascular Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi E |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagara, MSRIT Post, Banglore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
09739185643 |
| Fax |
|
| Email |
vyshnavigoud18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Veena Kiran Nambiar |
| Designation |
Professor, M S Ramaiah College of Physiotherapy |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagara, MSRIT Post, Banglore-560054
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
|
| Email |
veenakn.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi E |
| Designation |
Post Graduate Student |
| Affiliation |
Ramaiah College of Physiotherapy |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagara, MSRIT Post, Banglore-560054
KARNATAKA
560054
India |
| Phone |
09739185643 |
| Fax |
|
| Email |
vyshnavigoud18@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Memorial Hospital, M S Ramaiah Nagara, MSRIT Post, Bangalore- 560054 |
|
|
Primary Sponsor
|
| Name |
M S Ramaiah Medical College Hospitals |
| Address |
Ramaiah College of Physiotherapy M S Ramaiah Nagara, MSRIT Post, Bangalore- 560054 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vaishnavi E |
M S Ramaiah Memorial Hospital |
Ramaiah College of Physiotherapy M S Ramaiah Nagara, MSRIT Post, Banglore-560054
Bangalore
KARNATAKA |
09739185643
vyshnavigoud18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee M S Ramaiah Medial College and Hospitals |
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 |
Conventional Patient Educataion |
Patients in the control group will receive routine discharge education as currently practiced in the hospital. This includes brief verbal instructions regarding medication adherence, follow-up care, lifestyle modification, and home-based activity progression.
Additionally, a printed informational pamphlet with general cardiac rehabilitation advice will be provided.
No structured counseling sessions or CR familiarisation visit will be given. |
| Intervention |
Structured Patient Education Program |
Participants in the intervention group will receive a Structured Patient Education Program during hospital stay before discharge. The program will be delivered over three consecutive days:
Day 1: One-to-one counselling session on the purpose, benefits, and components of Cardiac Rehabilitation. A printed educational pamphlet will be provided. The session may take 30-40 minutes.
Day 2: Video-based education covering lifestyle modification, exercise safety, and commonly asked questions about CR. The session may take 30-40 minutes.
Day 3: Cardiac Rehabilitation familiarisation visit, including guided orientation to the CR facility and introduction to the rehabilitation team.
Each session will last approximately 30 to 40 minutes which is 90-100 minutes divided into 3 sessions.
Follow-up will be conducted 15 days post-discharge to assess CR enrolment and perceived barriers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above diagnosed with cardiovascular disease (e.g., post-MI, post-angioplasty, post-CABG, valvular heart disease, or heart failure).
2. Medically stable and cleared for participation in cardiac rehabilitation education.
3. Able to understand and provide informed consent.
4. Willing to participate in the education sessions and follow-up after discharge. |
|
| ExclusionCriteria |
| Details |
1. Patients with unstable cardiac conditions (e.g., ongoing chest pain, arrhythmia, or hemodynamic instability).
2. Those with cognitive impairment, psychiatric illness, or communication difficulties that limit understanding of education sessions.
3. Patients with severe comorbidities (e.g., advanced renal, hepatic, or respiratory failure) that prevent participation.
4. Patients unwilling to participate or unable to provide informed consent.
5. Patients discharged to other facilities where follow-up within 15 days is not feasible. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients who enroll into Cardiac Rehabilitation after discharge(intervention vs Control) |
Cardiac rehabilitation enrolment rate at 15 days post-discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived barriers to Cr participation assessed using the Cardiac Rehabilitation Barriers Scale at 15 days post-discharge. |
15 days post-discharge |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
24/11/2025 |
| 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="1"
Months="0"
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
|
Cardiac Rehabilitation (CR) is an effective secondary prevention program for patients with cardiovascular diseases, but its enrollment rate remains low in many settings. Patients often express willingness to attend CR while in the hospital, yet do not follow through after discharge. One major reason is lack of structured and reinforced patient education. This study aims to determine whether a Structured Patient Education Program delivered before hospital discharge can improve CR enrollment rates among eligible cardiac patients.
The study will be a randomized, parallel-group, active-controlled trial. A total of 220 patients meeting the inclusion criteria will be randomly assigned to either the intervention group or the control group.
The intervention group will receive a Structured Patient Education Program over three days, including one-to-one counseling, video-based education, and a familiarisation visit to the CR facility. The control group will receive routine discharge advice and pamphlet information.
CR enrollment status and perceived barriers will be assessed 15 days post-discharge using the Cardiac Rehabilitation Barriers Scale (CRBS). The primary outcome is the rate of CR enrollment. The study will help determine whether structured education can improve participation in CR programs. |