| CTRI Number |
CTRI/2024/12/077814 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"How Heart Patients Understand Their Health, Follow Medication Plans, and Live Well Every Day" |
|
Scientific Title of Study
|
Assessment of Health Literacy, Medication Adherence and Health-Related Quality of Life in patients with cardiovascular diseases |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikkina Venkata Sai Sri Harsha |
| Designation |
Student |
| Affiliation |
Prasanna School of Public Health, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9394230900 |
| Fax |
|
| Email |
bikkina.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kamath |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Prasanna School of Public Health, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajesh.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Kamath |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Prasanna School of Public Health, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajesh.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Departmant of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Academy, Manipal |
| Department of Cardiology, Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Bikkina Venkata Sai Sri Harsha |
| Address |
Departmant of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Academy, Manipal |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Rajesh Kamath |
Kasturba Hospital |
Department of Cardiology, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
7760218342
rajesh.kamath@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years.
Outpatients in the cardiology department.
Confirmed diagnosis with disease duration of more than six months of Hypertension, ischemic heart disease, angina, myocardial infarction, heart failure, coronary artery disease, and arrhythmias.
The presence of comorbid conditions and willingness to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age.
In-patients admitted to the cardiology department.
Confirmed diagnosis with a disease duration of less than six months.
Excluding patients with cognitive impairment and not providing informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| health-related quality of life is the primary outcome that helps in understanding the overall well-being of cardiovascular patients in the progression of the disease based on medication adherence and usage patterns |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes are health literacy & medication adherence, which help to understand the medication intake patterns based on their literacy level, which helps in assessing the quality of life & improvement patterns |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="641"
Sample Size from India="641"
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)
|
16/12/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
AIM: To assess health literacy, medication adherence and health-related quality of life in cardiovascular disease (CVD) patients. OBJECTIVES: Primary objective To assess health literacy, medication adherence, and health-related quality of life (HRQoL) among patients with cardiovascular diseases. Secondary objective To analyse the relationship between health literacy, medication adherence, and health-related quality of life in cardiovascular patients. Study materials: A standardised questionnaire, i.e., Short Form 36 (SF-36) for health-related quality of life, will be used. The newest vital sign (NVS) questionnaire for health literacy, the medication adherence rating scale (MARS) for medication adherence, and a validated data collection proforma for the demographic parameters. Author permission has been obtained for these questionnaires. Demographic data such as age, gender, economic status, education level, and marital status will be collected. Study procedure: The outpatients in the cardiology department will be initially screened, and cases will be selected based on specific inclusion and exclusion criteria. Consent will be obtained from the patients. Patient data will be collected. Health literacy, medication adherence, and health-related quality of life will be analysed. The relationships between health literacy, medication adherence, and health-related quality of life will be analysed. Results and Conclusion
Statistical methods: Descriptive statistics, inferential statistics and correlation analysis will be calculated.
|