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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04613245
Other study ID # Serial 39-2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date March 1, 2021

Study information

Verified date December 2020
Source Cairo University
Contact Youssef
Phone +201149495552
Email youssef_naglaa@cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date March 1, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant's age: 18 years or older - medically diagnosed with bronchial asthma Exclusion Criteria: - not medically diagnosed with asthma by a physician

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Egypt Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma Control Questionnaire (ACQ) 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). One week
Secondary Mini Asthma Quality of Life Questionnaire 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". two weeks
Secondary Perceived Stress Scale 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. month
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