A Survey to Assess Effects of Covid-19 on Cardiovascular Patients

August 10, 2020 updated by: EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Centro en Insuficiencia Cardiaca, Mexico

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • Recruiting
        • Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia
        • Contact:
        • Principal Investigator:
          • EDUARDO CHUQUIURE-VALENZUELA, MD MSc
        • Sub-Investigator:
          • ALAN FUENTES, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Basal

All adults (age >18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent.

A survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2019 ( without covid-19 )
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 Names:
  • STRATA survey
Ourbreak

All adults (age >18 years), both gender, Heart failure patients (european society of cardiology ) criteria, sign consent.

A survey to access information about symptomatology, treatment, and medical care in period may 15 to june 15, 2020 ( ongoing covid-19 )
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 Names:
  • STRATA survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NYHA class deterioration
Time Frame: 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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea deterioration
Time Frame: 1 year
physiological parameter to worsening of shortness of breath perception, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021).Dichotomic scale presence or absence
1 year
Paroxysmal nocturnal dyspnea deterioration
Time Frame: 1 year
Physiological parameter to worsening of dyspnea that suddenly occurs to decubitus, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence.
1 year
Edema
Time Frame: 1 year
Physiological parameter to worsening of quantification of swollen ankles in both pelvic limbs, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence
1 year
Daily activities In the last four weeks? Please, mention if you a perceived limitation on : Walking deterioration
Time Frame: 1 year
a perceived limitation on walking more 500 meters, in last four weeks. Basal and follow-up measures: Basal on June 2020. Follow up: every three months and a year (June 2021). Dichotomic scale presence or absence.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro en Insuficiencia Cardiaca, Mexico

Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez
Medica Sur Clinic & Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Anticipated)

June 15, 2021

Study Completion (Anticipated)

July 15, 2021

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD PLAN Eduardo Chuquiure-Valenzuela is Principal investigator, conceptual protocol designer, performed statistics, write manuscript and draft corrections.

Alan Fuentes-Mendoza, Emmanuel Tapia-López, Daniel García-Romero Elyz Cortez-Lopez and Alejandra Marin-Sanchez, collaborate in clinical, research and analysis activities for CENTRO EN INSUFICIENCIA CARDIACA, Also, they assist in telephone interviews, writing of the manuscript. performed and checked statistics, co- writer, and draft corrections.

Laura Rodríguez Chávez, Nilda Espíndola Zavaleta, Gerardo Vieyra Herrera, and Enrique Lopez Mora, are affiliated cardiologists, who participate in the draft revision for publication.

IPD Sharing Time Frame

august 1, 2021 to december 30,2021

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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