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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04508920
Enrollment
76
Registered
2020-08-11
Start date
2019-05-15
Completion date
2021-07-15
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Failure

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.

Interventions

OTHERSymptomatology, 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

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez
CollaboratorOTHER
Medica Sur Clinic & Foundation
CollaboratorOTHER
Centro en Insuficiencia Cardiaca, Mexico
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
NYHA class deterioration1 yearNYHA 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

Secondary

MeasureTime frameDescription
Dyspnea deterioration1 yearphysiological 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
Paroxysmal nocturnal dyspnea deterioration1 yearPhysiological 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.
Edema1 yearPhysiological 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
Daily activities In the last four weeks? Please, mention if you a perceived limitation on : Walking deterioration1 yeara 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.

Countries

Mexico

Contacts

Primary ContactEDUARDO CHUQUIURE-VALENZUELA, MD
echuquiurev@yahoo.com+525554017407
Backup ContactALAN FUENTES-MENDOZA, MD
alan_fm@hotmail.com+524621073512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026