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Health-Related Quality of Life of Patients With Asthma During the Pandemic of COVID-19 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04613245
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Naglaa Fathy Afifi Youssef, Cairo University

Brief Summary:

Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment.

Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers.

Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19.

Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients.

Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.


Condition or disease
Asthma Chronic Bronchial Asthma

Detailed Description:

Asthma is a chronic inflammatory disease of the lower respiratory tract which derives from a combination of genetic predisposition with environmental exposure to several factors. It is a chronic respiratory disease that results in morbidity, mortality, and impaired health-related quality of life (HRQoL). It is estimated that 334 million people have asthma worldwide.

Nowadays, the COVID-19 epidemic causes stress not only to healthy people but also to people with unhealthy conditions. Excess psychological stress (either in quality, quantity, frequency, and/or duration) could push susceptible individuals to ultimately develop clinical asthma. Depression was significantly associated with asthma interference with daily activities, breathlessness, night symptoms, use of bronchodilators, and poor compliance with medical treatment.

Covid-19 pandemic induced the countries around the world to require from its citizens not to ask for health care support rather than in emergency situations and through utilizing telemedicine. This action aims to control spreading the infection with viruses as well as to reduce the workload on the healthcare providers.

Although asthma is not listed as one of the chronic conditions that might complicate coronavirus infections, asthma people might have a high-stress level that might induce their asthma attack which consequentially reflects on their quality of life. People with asthma have a unique experience rather than people with other health conditions during COVID-19.

Patients with asthma experience a lot of stressors that might induce asthma and impaired their HRQOL such as overuse of antiseptic substances, stay home with a sedentary lifestyle, the sudden shift to telemedicine, and electronic work from home. Also, as a result of the similarity of asthma symptoms with coronavirus symptoms, the patient might have a continuous sense of uncertainty that s/he is infected with the COVID-19 virus, and this suspicion can increase the psychological overburden on these patients.

Therefore, all these stressors should be evaluated to recognize their health needs and the kind of social and health support that should be provided to them during the pandemic time. Also, Identifying the predictors of HRQOL among patients with asthma during the pandemic of COVID-19 is urgently required.

A cross-sectional analytical design will be utilized.

The study participants will be adults (18 years or older) who have been diagnosed with bronchial asthma or pulmonary disease.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Health-Related Quality of Life of Patients With Asthma and Its Associated Factors During the Pandemic of COVID-19
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
Patient with asthma



Primary Outcome Measures :
  1. Asthma Control Questionnaire (ACQ) [ Time Frame: One week ]
    ACQ has a multidimensional construct assessing symptoms (5 items--self-administered) and rescue in bronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff, but it will not be applied in the current study as it will be difficult to be self-reported by the participants. 7-point scale (0=no impairment, 6= maximum impairment for symptoms. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).


Secondary Outcome Measures :
  1. Mini Asthma Quality of Life Questionnaire [ Time Frame: two weeks ]
    The MiniAQLQ will be utilized to investigate the HRQoL of the participants. The Mini AQLQ-S has 15 questions that gives an overall summary index and four domains: activity limitation, symptoms, emotional function, and environmental stimuli. The questions all refer to the "last two weeks" and use seven Likert-type response options e.g., seven response options ranging from "all of the time" to "none of the time".

  2. Perceived Stress Scale [ Time Frame: month ]
    Perceived Stress Scale is a self-reported measure of the degree to which situations in an individual's life are perceived as stressful. PSS has 14 items can assess the degree to which individuals found their life unpredictable, uncontrollable, and overloaded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study participants will be adults who have been diagnosed with bronchial asthma or pulmonary disease.
Criteria

Inclusion Criteria:

  • Participant's age: 18 years or older
  • medically diagnosed with bronchial asthma

Exclusion Criteria:

  • not medically diagnosed with asthma by a physician

Information from the National Library of Medicine

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): NCT04613245


Contacts
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Contact: Youssef +201149495552 youssef_naglaa@cu.edu.eg

Locations
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Egypt
Egypt Recruiting
Cairo, Egypt
Contact: Youssef    +201149495552    youssef_naglaa@cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Naglaa Youssef Cairo University
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Responsible Party: Naglaa Fathy Afifi Youssef, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT04613245    
Other Study ID Numbers: Serial 39-2020
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naglaa Fathy Afifi Youssef, Cairo University:
Quality of life
Health related quality of life
patient reported outcome
Asthma
COVID-19
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases