A Survey to Assess Effects of Covid-19 on Cardiovascular Patients
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| ClinicalTrials.gov Identifier: NCT04508920 |
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Recruitment Status :
Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Cardiovascular Diseases Heart Failure | Other: Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA) |
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 [Patient Registry] |
| Estimated Enrollment : | 76 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 18 Months |
| Official Title: | A Survey to Assess Effects of the Covid-19 Pandemic on Symptomatology, Treatment and Medical Care for Cardiovascular Patients |
| Actual Study Start Date : | May 15, 2019 |
| Estimated Primary Completion Date : | June 15, 2021 |
| Estimated Study Completion Date : | July 15, 2021 |
| 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 Name: 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 Name: STRATA survey |
- 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
- 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
- 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.
- 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
- 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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508920
| Contact: EDUARDO CHUQUIURE-VALENZUELA, MD | +525554017407 | echuquiurev@yahoo.com | |
| Contact: ALAN FUENTES-MENDOZA, MD | +524621073512 | alan_fm@hotmail.com |
| Mexico | |
| Centro de Insuficiencia Cardiaca Instituto Nacional de Cardiologia | Recruiting |
| Mexico City, Mexico, 14080 | |
| Contact: CHUQUIURE-VALENZUELA EDUARDO, MD, MSc +5215554017407 echuquiurev@yahoo.com | |
| Principal Investigator: EDUARDO CHUQUIURE-VALENZUELA, MD MSc | |
| Sub-Investigator: ALAN FUENTES, MD | |
| Principal Investigator: | EDUARDO CHUQUIURE-VALENZUELA, MD | Centro en insuficiencia cardiaca |
Documents provided by EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Centro en Insuficiencia Cardiaca, Mexico:
Other Publications:
| Responsible Party: | EDUARDO CHUQUIURE-VALENZUELA MD MSc FACC, Principal investigator, Centro en Insuficiencia Cardiaca, Mexico |
| ClinicalTrials.gov Identifier: | NCT04508920 |
| Other Study ID Numbers: |
20-1156 |
| First Posted: | August 11, 2020 Key Record Dates |
| Last Update Posted: | August 11, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
| Time Frame: | august 1, 2021 to december 30,2021 |
| Access Criteria: | open access |
| URL: | http://cardiologia.org.mx |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Cardiovascular Diseases |