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CTRI Number  CTRI/2020/07/026807 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On: 05/01/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Qualitative 
Study Design  Other 
Public Title of Study   Attitudes and practices towards rehabilitation for individuals with multiple problems in those with heart disease  
Scientific Title of Study   Attitudes and practices towards cardiac rehabilitation and multimorbidity in acute cardiovascular disease: A qualitative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abraham Samuel Babu 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  abraham.babu@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abraham Samuel Babu 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  abraham.babu@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Abraham Samuel Babu 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  abraham.babu@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal - 576104, Karnataka 
 
Primary Sponsor  
Name  None 
Address  NA 
Type of Sponsor  Other [None] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abraham Samuel Babu  Manipal Academy of Higher Education  Department of Physiotherapy Manipal College of Health Professions MAHE
Udupi
KARNATAKA 
9742502838

abraham.babu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cardiac rehabilitation professionals (Cardiologists, Nurses and Physiotherapists) 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Cardiac rehabilitation professionals (i.e., Cardiologists, Physiotherapists and nurses) involved in cardiac rehabilitation (>3days/wk) for at least 1 year 
 
ExclusionCriteria 
Details  Healthcare professionals not actively working in cardiac rehabilitation (<2 days/ week) <1year 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Attitudes & practices towards cardiac rehabilitation   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
None  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/07/2020 
Date of Study Completion (India) 31/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Cardiac rehabilitation (CR) is an essential part of care for patients with cardiovascular disease (CVD that reduces hospital admissions and improves the quality of life. Despite these benefits, CR is grossly underutilized across the globe. In a country like India, where the burden of disease is high and the economic impact of the disease considerable, it is important to utilize cost effective interventions to supplement existing care to minimize secondary complications. A recent survey from around the world found that India is ranked among the lowest in ability to provide CR. Among the low middle income countries, India fares better than some other, but in India, ability to deliver and meet the demand is greatly disproportionate. This has been seen in a review of CR, which found only a limited number of programs in India.

Various barriers to CR have been thought to contribute to the lack of CR in India, one of them being the lack of referrals. Since, CR requires an integrated approach, a better understanding of factors limiting referral to CR requires further explorationThe benefits of CR are focused are seen for mental health and overall benefits. However, studies focusing on the effects of CR on multimorbidity are limited. Therefore, in an effort to better understand why CR is not being utilised adequately and to determine whether multimorbidity poses any challenges to CR, this study is being carried out through a qualitative methodology on 30-60 CR professionals (approximately 10-20 eeach of cardiologists, nurses and physiotherapists)

 
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