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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Cardiac rehabilitation professionals (Cardiologists, Nurses and Physiotherapists) |
|
Intervention / Comparator Agent
|
|
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 exploration. The 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) |