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CTRI Number  CTRI/2024/04/065432 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find the relationship between Health Literacy, Readiness for Digital Health and Caregiver Burden in carers of individuals with Heart Failure  
Scientific Title of Study   Relationship between Health Literacy, Readiness to Digital Health and Caregiver Burden among carers of individuals with Heart Failure 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Prabhu 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Room 215, Department of Physiotherapy, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav nagar, Manipal, Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  6362708744  
Fax    
Email  shreya6.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Abraham S Babu 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Room 215, Department of Physiotherapy, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav nagar, Manipal, Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9742502838  
Fax    
Email  abraham.babu@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Shreya Prabhu 
Designation  Student 
Affiliation  Manipal Academy of Higher Education 
Address  Room 215, Department of Physiotherapy, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav nagar, Manipal, Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  6362708744  
Fax    
Email  shreya6.mchpmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Cardiology, Kasturba Hospital, Manipal, Udupi, Karnataka 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, 576104 
Type of Sponsor  Research institution and hospital 
 
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 S Babu  Kasturba hospital  Cardiac Rehabilitation Clinic, Room number 33, Kasturba Hospital, Manipal, Udupi, Karnataka
Udupi
KARNATAKA 		 9742502838

abraham.babu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital Institutional Ethics Committee- 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary caregiver to patient with Heart Failure 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Who can understand Kannada or English language.
2. Primary informal caregiver to an individual with diagnosed heart failure at least one year 
 
ExclusionCriteria 
Details  Pre-existing functional impairment
Comorbidities such as stroke, cancer and mental health disorder
Significant locomotor disability
Severe cognitive impairment (MoCA less than 26)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Zarit Burden Interview

2. European Health Literacy Survey Questionnaire (HLS- EU-Q16)

3. Digital Health Readiness Questionnaire


 		 The outcome will be assessed once, during OPD follow- up. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="82" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/04/2024 
Date of Study Completion (India) 13/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   Heart Failure (HF) is a complex clinical syndrome that underlines inability of heart to perform its circulatory function with desired efficiency due to structural and/ or functional alterations. Caregiver burden(CB) is defined as “The extent to which caregivers perceive that caregiving has had an adverse effect on their emotional, social, financial, physical and spiritual functioning” . CB in those with HF is present in 20-50% of caregivers. Health literacy (HL) is “the degree to which individuals can obtain, process and understand basic health information and services needed to make appropriate health decision”. HL among caregivers has been shown to affect self- management in HF.  Digital readiness is defined as “motivation and competence to adopt, use and spread digital health care technologies effectively.”  Despite of digital advances, there is lack of focus on caregivers.   

There is lack of literature on the relationship between Caregiver burden, Health Literacy and digital readiness among carers of individuals with HF

 
   
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