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Clinical Trials/CTRI/2024/12/077814
CTRI/2024/12/077814Not yet recruitingNot Applicable

Assessment of Health Literacy, Medication Adherence and Health-Related Quality of Life in patients with cardiovascular diseases

Bikkina Venkata Sai Sri Harsha1 site in 1 country641 target enrollmentStarted: December 16, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
641
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 8 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor
Bikkina Venkata Sai Sri Harsha
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Bikkina Venkata Sai Sri Harsha

Prasanna School of Public Health, Manipal

Study Sites (1)

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