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临床试验/NCT03246035
NCT03246035已完成不适用

A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure

Jewish General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
All-cause death, hospital readmission, or ED revisit

研究概览

简要总结

A randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. Specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.

详细描述

Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use a large proportion of available resources, and are at higher risk for complications, including readmission to hospital after discharge. The investigators believe that by improving access to follow-up, optimizing self-care, and addressing the various cognitive and physical limitations of frailty, it will be possible to improve quality of life and reduce readmission rates for frail patients with ADHF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who presented to the ED and who are being discharged with a primary or secondary diagnosis of ADHF
  • •Frailty, defined as a FRAIL score >=3/5 or Clinical Frailty Scale (CFS) score >=5/9
  • •Informed consent provided by the patient or proxy

排除标准

  • •Significant dementia or active delirium
  • •Severe frailty, defined as a CFS score >=8/9
  • •Prohibitive language barrier
  • •Primary address outside of Quebec
  • •Patient deemed to be palliative or moribund by treating team

研究组 & 干预措施

Control Group (Standard Care)

Active Comparator

The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.

干预措施: Control Group (Standard Care) (Other)

Intervention Group

Experimental

The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline.

干预措施: Intervention Group (Behavioral)

结局指标

主要结局

All-cause death, hospital readmission, or ED revisit

时间窗: 90 days

次要结局

  • Recruitment rate(90 days)
  • Frailty Index(90 days)
  • Informed consent validation (qualitative)(90 days)
  • Self-Care Index(90 days)
  • Rate of return visits to any ER for any medical issue(30 days)
  • Rate of admission to hospital at 90 days(90 days)
  • Heart Failure Symptom Scale(90 days)
  • Incidence of adverse effects from medication(90 days)
  • Attrition rate(90 days)
  • All-cause death, hospital readmission, or ED revisit(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Afilalo

Researcher

Jewish General Hospital

研究点 (1)

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