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临床试验/CTRI/2024/09/073984
CTRI/2024/09/073984已完成2 期

A pilot randomised control trial comparing telephonic message based follow up versus standard care in patients discharged after hospital admission for acute heart failure in general medical wards.

Fluid Research Fund Office of Research1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年9月18日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Composite outcome of Acute Coronary Syndrome, Stroke, All cause readmission and All cause mortality

研究概览

简要总结

Heart failure is one of the major causes of mortality in India. The acute cardiac conditions are mostly related to ischemia, arrhythmia, infections. The heart failure is prone for acute decompensation by any of the above inciting event and worsening the patient condition and requiring readmissions often with high risk of major adverse cardiovascular event. There are multiple studies done worldwide documenting the initial 90 days post discharge is the vulnerable period for such readmissions. Among the various causes of readmission, non compliance to drugs ,life style changes contribute the majority of cases. various studies has shown intervening by medical team at this vulnerable period causes reduction in readmissions -one such intervention is the telephonic based follow up with health guidance and monitoring after discharge. In this study. the population will be randomized  into 2 arms at discharge after acute heart failure. The control arm receiving standard care while intervention arm will receive telehealth services in the form of 6 messages each a week for 6 weeks post discharge and a call by principal investigator at 6th week along with standard of care .The intervention is aimed at improving patients adherence to drugs, diet advice, lifetsyle modifications needed thereby anticipating the prolonging the time of occurrence of major adverse cardiovascular events in the vulnerable 90 days post discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
16.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Those stable discharged patients with acute heart failure of ischemic etiology as diagnosed by the treating medical team entered in discharge summary Those who provide consent.

排除标准

  • Heart failure patients with non ischemic etiology.
  • Those who are unfamiliar with mobile phone usage.
  • Those who didnot provide consent.
  • Those who are not in a stable state at time of discharge.

结局指标

主要结局

Composite outcome of Acute Coronary Syndrome, Stroke, All cause readmission and All cause mortality

时间窗: 90 days after discharge

次要结局

  • To compare all cause readmission at the end of 3 months among telehealth followed up patients versus standard care.(3 months)
  • to compare all cause mortality at the end of 3 months among telehealth followedup patients versus standard care.(3 months)
  • To compare major adverse cardiovascular events among telehealth followed up patients versus standard care.(3 months)
  • To compare patients Knowledge.Attitude practice among two arms after 3 months(3 months)

研究者

发起方
Fluid Research Fund Office of Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DrsivaranjaniK

Christian medical college

研究点 (1)

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