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CTRI Number  CTRI/2025/10/095676 [Registered on: 07/10/2025] Trial Registered Prospectively
Last Modified On: 06/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Awareness on self care, medicine use, and vitamin B12 deficiency 
Scientific Title of Study   A study to assess the awareness on self-health management, medication adherence and vitamin B12 deficiency among patients with coronary artery disease (CAD) in a selected tertiary hospital in Udupi district, Karnataka. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Padmapriya L 
Designation  M.Sc. Nursing 
Affiliation  Manipal College of Nursing 
Address  4th floor, door no 400A, Manipal college of Nursing, Madhav Nagar, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9080995438  
Fax    
Email  padmapriya2105@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Melita sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing 
Address  5th floor, door no:502,Manipal College of Nursing, Madhav Nagar, Manipal academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Melita sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing 
Address  5th floor, door no:502,Manipal College of Nursing, Madhav Nagar, Manipal academy of Higher Education, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Madhava Nagar, Manipal-576104 Udupi District, Karnataka, India. 
 
Primary Sponsor  
Name  Padmapriya L 
Address  4th floor, door no 400A, Manipal college of Nursing, Madhav Nagar, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Other [Self sponsor] 
 
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 Mahidhar Jeedigunta  Kasturba Hospital  Room No 37,Outpatient department of Cardiology, Kasturba Hospital, Manipal
Udupi
KARNATAKA 		 9592914956

mahidhar.jeedigunta@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba hospital Institutional Ethics Committee-2(Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients diagnosed with CAD:
1)above 18 years.
2)attending cardiac OPDs and being admitted to cardiology wards.
3)who can understand, read, and write Kannada or English 
 
ExclusionCriteria 
Details  1)Patients who are not willing to participate in the study.
2)Patients with CAD and admitted to the cardiac ICU. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In this study,
the outcome measures are, awareness on self-health management, medication adherence and vitamin
B12 deficiency.
 		 The outcome variables will be assessed only once during the study period. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="428"
Sample Size from India="428" 
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)   17/10/2025 
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  

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality globally and in India. Effective management requires not only appropriate treatment but also patient awareness, medication adherence, and attention to nutritional deficiencies such as vitamin B12. Vitamin B12 deficiency has been linked to cognitive decline, which may further affect a patient’s adherence to prescribed therapies. Despite the existence of studies on self-health management, medication adherence, and vitamin B12 deficiency individually, no research has examined these three factors together in CAD patients.

This prospective cross-sectional study will be conducted in the cardiology wards and OPD of a tertiary hospital in Udupi district, Karnataka, from October 2025 to October 2026. A total of 428 CAD patients meeting inclusion criteria will be recruited through purposive sampling. Data will be collected using four tools:

1. Background information 

    • a) Sociodemographic proforma
    •  b) Clinical proforma
2. Tool to assess awareness on self-health management (Self developed)
3. Modified Hill-Bone Medication Adherence Scale,
4. Screening tool for symptoms of vitamin B12 deficiency (Self developed)

The objectives are to:

1.To assess the awareness on self-health management among patients with CAD using tool to assess awareness on self-health management. 

2. To identify the proportion of patients with CAD having vitamin B12 deficiency using the screening tool on symptoms of vitamin B12 deficiency. 

3. To determine the medication adherence among patients with CAD using the Hill-Bone Medication Adherence scale. 

4. To find the relationship between medication adherence and vitamin B12 deficiency among patients with CAD. 

5. To find the association between awareness on self-health management with the selected variables. 

Data will be analysed using descriptive and inferential statistics (t-test, ANOVA, Chi-square, correlation, and regression) with Jamovi software at a 5% level of significance.

The study poses minimal risks, limited to the time required for questionnaire completion, but has potential benefits in enhancing patient education, promoting adherence, and identifying early symptoms of vitamin B12 deficiency. Findings may guide the development of educational materials and contribute to improved cardiovascular health, aligning with Sustainable Development Goal 3: Good Health and Well-being.

 
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