Assessment of cardiovascular disease related distress and psychosocialdeterminants: A prospective observational study

Not yet recruiting

Conditions: Subsequent ST elevation (STEMI) myocardial infarction of anterior wall,

Registration Number: CTRI/2025/03/082119

Lead Sponsor: DR KUSHAL PUJARA

Brief Summary: Cardiovascular disease (CVD) is a major health concern globally and in India contributing significantly to

morbidity and mortality. While medical treatments and surgical interventions have advanced the

psychosocial aspects of CVD such as patient distress and its impact on outcomes are less understood and

thus often neglected. This study aims to address this gap by systematically evaluating the distress

experienced by CVD patients. Understanding these relationships is crucial for developing holistic care

strategies that encompasses both physical and psychological impacts ultimately aiming to improve patient

management, enhance the quality of life and reduce the burden of CVD related distress.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients willing to provide informed consent Patients above 18 years of age Patients with primary diagnosis of Acute Coronary Syndrome (Unstable angina, NSTEMI, STEMI) Both Male and female patients are eligible.

Exclusion Criteria

Patients unwilling to provide consent Patients with a history of any major surgery less than a month ago or undergoing a surgery Patients who are Pregnant or lactating Psychiatric patients with hindered mental capacity.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the levels of distress related to cardiovascular condition.	15 months
To study	15 months
the impact of socio-economic status and psychosocial determinants on cardiovascular disease related	15 months
distress.	15 months

Secondary Outcome Measures

Name	Time	Method
To measure the impact of	polypharmacy on cardiovascular disease related distress.
To prepare and validate Cardiac Distress	Inventory (CDI) and Adherence in Chronic Disease Scale (ACDS) in vernacular language (Gujarati)
To assess the level of medication adherence	15 months

Trial Locations

Locations (1): Shree Krishna Hospital and Pramukh Swami Medical College, Karamsad
🇮🇳
Anand, GUJARAT, India
Shree Krishna Hospital and Pramukh Swami Medical College, Karamsad
🇮🇳Anand, GUJARAT, India
DR KUSHAL PUJARA
Principal investigator
9825175197
drkushalpujara@yahoo.com