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

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

Detailed Description

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.

Protocol was approved by the ethics and investigational committees. All patients previously
signed informed consent. Additionally, prior to the telephone survey, a verbal assent was
requested. Absolute confidentiality of all patient data was declared.

Unknown status
Cardiovascular Diseases
Heart Failure

Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)

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 Mexico14 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 (appendix). A causality association question of emotional distress perception was added. We recorded mortality and rehospitalization
Other Name: STRATA survey

Eligibility Criteria

Inclusion Criteria:

- confirmed diagnosis of HF, according with the ESC guidelines criteria

- both genders,

- above 18 years,

- agreed to participate

Exclusion Criteria:

- 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Mexico
Locations

Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia
Mexico City, Mexico

Investigator: CHUQUIURE-VALENZUELA EDUARDO, MD, MSc
Contact: +5215554017407
echuquiurev@yahoo.com

Investigator:

Contacts

EDUARDO CHUQUIURE-VALENZUELA, MD
+525554017407
echuquiurev@yahoo.com

ALAN FUENTES-MENDOZA, MD
+524621073512
alan_fm@hotmail.com

EDUARDO CHUQUIURE-VALENZUELA, MD, Principal Investigator
Centro en insuficiencia cardiaca

Centro en Insuficiencia Cardiaca, Mexico
NCT Number
MeSH Terms
Cardiovascular Diseases