| CTRI Number |
CTRI/2025/02/079961 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess health literacy, treatment adherence and factors influencing treatment adherence among patient with coronary artery disease in selected tertiary care hospital of udupi district, karnataka. |
|
Scientific Title of Study
|
A descriptive study to assess health literacy, treatment adherence and factors influencing treatment adherence among patients with coronary artery disease in a selcted tertiary care hospital of 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 |
Jahnvi Chetry |
| Designation |
student (MSc nurisng) |
| Affiliation |
manipal college of nursing |
| Address |
Manipal college of Nursing(MCON)
Manipal Academy of Higher Education(MAHE)
Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8918876866 |
| Fax |
|
| Email |
jahnvichetry34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMelita Sheilni |
| Designation |
Associate Professor |
| Affiliation |
manipal college of nursing |
| Address |
Department of Medical Surgical Nursing
Manipal college of Nursing(MCON) Manipal Academy of Higher Education(MAHE) Udupi Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
8095976561 |
| Fax |
|
| Email |
shyli.mel@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrMelita Sheilni |
| Designation |
Associate Professor |
| Affiliation |
manipal college of nursing |
| Address |
Department of Medical Surgical Nursing
Manipal college of Nursing(MCON) Manipal Academy of Higher Education(MAHE) Udupi Karnataka
KARNATAKA
576104
India |
| Phone |
8095976561 |
| Fax |
|
| Email |
shyli.mel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kastruba Hospital, Manipal (Teaching hospital of KMC Manipal,a unit of MAHE)
Udupi-Hebri Rd, Madhv Nagar, Manipal, Karntaka 576104 India. |
|
|
Primary Sponsor
|
| Name |
manipal college of nursing |
| Address |
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Melita Sheilini |
Kasturba Hospital |
Department of cardiology, cardiology wards.
Udupi
KARNATAKA |
8095976561
shyli.mel@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I248||Other forms of acute ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of 18-65 years.
2.Those who are willing to participate in the study.
3.Participants who can read and write Kannada/English.
|
|
| ExclusionCriteria |
| Details |
1.Those who have a history of Stroke, mental illness, and dementia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study the outcome measures are, health Literacy and, treatment adherence among patients diagnosed with CAD . |
after 4 weeks of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="167"
Sample Size from India="167"
Final Enrollment numbers achieved (Total)= "167"
Final Enrollment numbers achieved (India)="167" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2025 |
| Date of Study Completion (India) |
31/07/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study will find the HL and treatment adherence among patients on CAD and highlight its importance in secondary prevention which will lead to effective self-health management and add to the quality of life of patients with CAD contributing to the Sustainable Developmental Goal 3: Good Health and Wellbeing. |