跳至主要内容
临床试验/NCT04508920
NCT04508920Unknown不适用

A Survey to Assess Effects of the Covid-19 Pandemic on Symptomatology, Treatment and Medical Care for Cardiovascular Patients

Centro en Insuficiencia Cardiaca, Mexico1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
76
试验地点
1
主要终点
NYHA class deterioration

研究概览

简要总结

The design included 152 patients with confirmed heart failure (HF) evaluated in two different periods of time: a baseline before the outbreak, and other during the outbreak of which 76 patients were randomized in each group. A care and follow-up guide was used as an instrument through a face-to-face survey (baseline group) and telemedicine (group outbreak). The primary outcome was the comparison of functional class modification observed in patients

详细描述

Population and Data Sources All patients included, confirmed diagnosis of HF, according with the ESC guidelines criteria, both genders, above 18 years, who agreed to participate. All HF outpatients belonged to an open follow-up cohort of the HF clinic of the National Institute of Cardiology of Mexico, which started enrollment since September 2016. Periodic determinations were planned, clinical, functional, therapeutic evaluations, and emotional distress. The present design is a nested comparative analysis through a care and follow-up guide to HF patients.

Data collection and outcomes Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico.

Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide . A causality association question of emotional distress perception was added. Investigators recorded mortality and rehospitalization.

The primary outcome was comparison of functional class modification, secondary outcomes were Clinical alterations related to HF worsening, Therapeutic modifications, Daily physical activities, and Self-perception of health status.

The protocol conducted to hypothesize that the clinical alarm data reported by patients, in an alternative in-home model, with tele-medical assistance, is a useful tool in follow-up, as in detecting therapeutic performances, and associated with the HF deterioration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of HF, according with the ESC guidelines criteria
  • both genders,
  • above 18 years,
  • agreed to participate

排除标准

  • Impediment to contacting patients
  • marked physical impairment
  • cognitive impairment that prevents optimal interrogation
  • Cultural barriers involving communication limitation (languages, dialects, reading and writing)
  • Patient doesn't want to participate.

结局指标

主要结局

NYHA class deterioration

时间窗: 1 year

NYHA class modification in the last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). NYHA Scale: Minimum: 1 to maximum :4

次要结局

  • Dyspnea deterioration(1 year)
  • Paroxysmal nocturnal dyspnea deterioration(1 year)
  • Edema(1 year)
  • Daily activities In the last four weeks? Please, mention if you a perceived limitation on : Walking deterioration(1 year)

研究者

发起方
Centro en Insuficiencia Cardiaca, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC

Principal investigator

Centro en Insuficiencia Cardiaca, Mexico

研究点 (1)

Loading locations...

相似试验