| CTRI Number |
CTRI/2024/09/073837 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed method |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding reasons why heart patients do not receive Cardiac Rehabilitation and finding solutions for it |
|
Scientific Title of Study
|
Exploring and Addressing gaps and capacity building
in Phase 2 Cardiac Rehabilitation: A Mixed Method Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariya Jiandani |
| Designation |
Professor Additional |
| Affiliation |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School
and Centre, Seth G S Medical College and KEM Hospital, Parel
East, Mumbai, India
Mumbai,
MAHARASHTRA ,India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820191106 |
| Fax |
|
| Email |
mpjiandani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mariya Jiandani |
| Designation |
Professor Additional |
| Affiliation |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School
and Centre, Seth G S Medical College and KEM Hospital, Parel
East, Mumbai, India
Mumbai,
MAHARASHTRA ,India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820191106 |
| Fax |
|
| Email |
mpjiandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mariya Jiandani |
| Designation |
Professor Additional |
| Affiliation |
Physiotherapy School and Centre Seth G S Medical College and KEMH |
| Address |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School
and Centre, Seth G S Medical College and KEM Hospital, Parel
East, Mumbai, India
Mumbai,
MAHARASHTRA ,India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820191106 |
| Fax |
|
| Email |
mpjiandani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy School and Centre Seth G S Medical College and KEMH Parel Mumbai 12 India |
|
|
Primary Sponsor
|
| Name |
Physiotherapy School & Centre Seth G S Medical College & KEMH |
| Address |
Room No 16, Ground Floor, CVTC Building, Physiotherapy School
and Centre, Seth G S Medical College and KEM Hospital, Parel
East, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Mariya Jiandani |
Physiotherapy School and Centre Seth GS Medical College and KEM Hospital |
Cardiovascular and Pulmonary Rehabilitation Department
Room No 16 Ground Floor
Cardiovascular and thoracic centre (CVTC) Building
Parel
Mumbai 12
India
Mumbai
MAHARASHTRA |
09820101196
mpjiandani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC III) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1. Administrators
2. Health care providers |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Administrators:
o Representatives from hospitals, government officials, health insurance companies, and policymakers involved in decision-making related to CR.
o Minimum of 2 years of experience in their role.
o Age range: 25-80 years.
o Willingness to participate and provide informed consent.
2. Healthcare Providers:
o Physiotherapists, nurses, occupational therapists, dieticians, physicians, cardiologists and cardiac surgeons involved in delivering CR.
o Minimum of 2 years of experience in their field.
o Age range: 25-80 years.
o Willingness to participate and provide informed consent.
3. Patients
• Individuals who have experienced cardiac events (e.g., coronary artery disease, myocardial infarction, heart failure) with or without interventions (e.g., angioplasty, CABG).
• Post-discharge and eligible for Phase 2 CR.
• Age range: 18-80 years.
o Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Administrators:
o Not involved in decision-making related to CR.
2.Healthcare Providers:
o Not involved in delivering CR
3. Patients
• Contraindications to participate in CR.
• Severe cognitive impairments or psychiatric conditions preventing informed consent or participation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Themes generated from the interview
2. percentage of consensus of delphi at round 1,2 and 3 |
1. Themes would be at Baseline once only
2. Delphi percentage consensus at baseline(round1), 4 weeks (round 2) and 8 weeks (Round 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
11/10/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Participating in cardiac rehabilitation (CR) has been found to have significant benefits for individuals with heart disease however it is underutilized. There is a huge gap where number of barriers such as referal, funding and transport have been identified for out patient (Phase 2 ) Cardiac Rehabilitation. This study explores the gaps by conducting interviews of administrators, health care providers,policy makers and focus group discussion with patients to understand the gaps, identify the current referal rate and develop a module which will address these gaps. The module will be validated using a Delphi method.
|