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

Bronchial Asthma Clinical Trial

— COVID-19  

Official title:

Health-Related Quality of Life of Patients With Asthma and Its Associated Factors During the Pandemic of COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04613245
• Other study ID #: Serial 39-2020
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic
• Bronchial Asthma

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