CTRI/2025/09/094404尚未招募不适用
Cardiac Disability and its demographic and socioeconomic Correlate in tertiary care centre: A Qualitative and Quantitative Analysis
SMS Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 702 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 702
- 试验地点
- 1
- 主要终点
- Quantify the occurrence of cardiac disability using the Global Disability Scale in a large tertiary care center in India.
研究概览
简要总结
This study aims to estimate the occurrence of cardiac disability among patients attending a tertiary care hospital and to evaluate its relationship with demographic and socioeconomic factors. Cardiac disability is defined as limitations in physical and functional capacity caused by heart diseases. The study will use the Cardiac Disability Score based on Heart Disease Categories to classify patients into mild, moderate, and severe disability groups. A mixed methods design will be used, combining quantitative and qualitative approaches. Quantitative data will include clinical assessments, echocardiographic findings, disability scoring, and structured questionnaires. Qualitative data will include in depth interviews and focus group discussions to explore the personal, social, and financial impact of living with cardiac disability. The findings are expected to provide insights into the burden of cardiac disability, its socioeconomic impact, and the gaps in healthcare access and social support. Results will help guide future healthcare planning and policy development for individuals living with cardiac disability.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants diagnosed with cardiac disability as per CDS-HDC classification categories A, B, or C (Mishra et al) will be included.
- •Group A: Heart diseases with mild or no hemodynamic abnormalities and low risk of progression such as small patent foramen ovale, small atrial septal defect, small patent ductus arteriosus, mild pulmonary stenosis, bicuspid aortic valve with mild regurgitation, Ebstein anomaly grade I or II, or repaired congenital heart disease without residual dysfunction.
- •Heart diseases improved by palliative procedures such as mild hypertrophic cardiomyopathy, viral myocarditis, rheumatic heart disease, Kawasaki disease, or mild stenotic lesions are also included.
- •Controlled systemic or pulmonary hypertension and mild arrhythmias such as Wolff-Parkinson-White syndrome are eligible.
- •Group B: Heart diseases with significant hemodynamic effects and moderate risk of progression such as pre- or post-tricuspid shunts, coronary arteriovenous fistula, Ebstein anomaly with moderate tricuspid regurgitation, congenital or degenerative valvular diseases, hypertrophic or dilated cardiomyopathy, coronary artery disease, and Marfan syndrome.
- •Patients with residual lesions after corrective surgery such as repaired tetralogy of Fallot, transposition of great arteries, coarctation of aorta, or valvar disease are included.
- •Heart diseases partially improved by palliation such as systemic to pulmonary artery shunt, pulmonary artery banding, or Senning or arterial switch palliation are also eligible.
- •Moderate systemic or pulmonary hypertension and significant arrhythmias such as complete heart block, long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic ventricular tachycardia are included.
- •Group C: Heart diseases with severe hemodynamic abnormalities or those requiring intervention such as large shunts, Eisenmenger syndrome, severe obstructive or regurgitant lesions, complex cyanotic congenital heart diseases, advanced cardiomyopathies, severe valvular diseases, or significant coronary artery disease.
- •Patients with persistent dysfunction, desaturation, arrhythmia, or hypertension after corrective surgery are included.
- •Palliated heart diseases with ongoing dysfunction such as Fontan or total cavopulmonary connection complications, persistent cyanosis, or severe pulmonary hypertension are also included.
- •Severe systemic or pulmonary hypertension with end-organ dysfunction and life-threatening arrhythmias such as ICD-dependent arrhythmias, arrhythmogenic right ventricular dysplasia, or intractable tachyarrhythmias are also eligible.
排除标准
- •Patients will be excluded if they have primary non-cardiac disabilities affecting daily functioning such as neurological, orthopedic, respiratory, or systemic causes unrelated to heart disease.
- •Patients unwilling or unable to provide informed consent will be excluded.
- •Patients unable to understand or respond reliably to the questionnaire, including those with severe cognitive impairment, language barriers, or illiteracy without caregiver support, will not be included.
- •Patients who have undergone major cardiac surgery or intervention such as bypass grafting, valve replacement, device closure, or stenting within the last twelve months will be excluded.
- •Patients with unstable hemodynamics, acute cardiac decompensation, or ongoing emergency cardiac procedures at the time of screening will not be eligible.
- •Patients with severe psychiatric illness interfering with study participation or those currently enrolled in another interventional clinical trial will also be excluded.
- •The principal investigator may exclude any participant considered unsuitable for safe and reliable participation.
结局指标
主要结局
Quantify the occurrence of cardiac disability using the Global Disability Scale in a large tertiary care center in India.
时间窗: 4 weeks
次要结局
- Assess the socioeconomic & demographic correlates of different levels of cardiac disability(4 weeks)
研究者
DEEPAK MAHESHWARI
SMS Medical College and Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Using a heart health app to detect early risks of heart disease, diabetes, hypertension and sleep disorders in healthy individuals.CTRI/2025/08/093780Philips Global Business Services1,000
招募中
不适用
Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis ImperfectaOsteogenesis ImperfectaNCT07287241Istituto Ortopedico Rizzoli40
尚未招募
不适用
A community survey to find how common disabilities are, their types, and related factors in Devarayasamudra village, Karnataka.CTRI/2025/08/093123Sri Devaraj URS Academy of Higher Education and Research,236
尚未招募
不适用
Study to Assess the Effect of a Home-Based Exercise Program on Recovery and Quality of Life in Patients with Heart DiseaseCTRI/2026/02/104879Christian Medical College Vellore100
招募中
不适用
Evaluation of Heart Failure Telemonitoring Eligibility CriteriaHeart FailureNCT07278583University Hospital, Clermont-Ferrand130