Symptom Clusters and Risk Factors of COVID-19 Patients

Symptom Clusters and Risk Factors of Patients Recovering From COVID-19 Caused by Omicron BA.2

Aim and objectives: To clarify the types, composition, distribution characteristics and risk factors of symptom clusters experienced by discharged patients with COVID-19, to lay the foundation for effective symptom management.

Background: Even when patients recover from COVID-19 patients, the virus can still cause many long-term effects or complications.Therefore, it is crucial to assess the symptoms and influencing factors of discharged patients with COVID-19.

Design: Cross-sectional survey. Methods:The investigators used the Post Discharge Experience Assessment Questionnaire for COVID-19 Patients and the Post Discharge Symptom Experience Risk Factor Questionnaire for COVID-19 Patients were used.Stratified random sampling was used to conduct a cross-sectional survey of 384 patients in recovery from COVID-19.Exploratory factor analysis was used to determine the cluster of symptoms, and a binary logistic regression analysis was used to identify the risk factors associated with this symptom cluster.

Study Overview

• Status: Completed
• Conditions: COVID-19; Symptoms and Signs; Patient Discharge

Detailed Description

1. A Symptom Experience Assessment Questionnaire for COVID-19 patients after recovery; a self-designed symptom assessment tool. The questionnaire takes the Symptom Experience Model (Armstrong et al., 2003) as the theoretical framework, and combines it with a systematic review of COVID-19 symptoms of patients in recovery to form the entry pool. The questionnaire included twenty-four symptoms, and each symptom included three dimensions: frequency, severity, and distress. Each dimension was scored using Likert scales. Taking frequency as an example, zero represents "never happened" and 4 represents "always existed". Cronbach's α coefficient: 0.953, split half reliability: 0.949; KMO: 0.842; (Bartlett's Test of Sphericity) Sig is 0.
2. A questionnaire on risk factors of symptom experience of COVID-19 patients after recovery: a self-designed survey tool.The questionnaire is based on the Symptom Experience Model. In this model, sociodemographic characteristics, disease-related characteristics, and personal characteristics are taken to be the leading factors of symptom experience, and three factors jointly mediate the occurrence and development of symptom experience. Based on this, combined with the results of the literature analysis and the clinical experience in our team, the investigators developed a questionnaire on the factors that influence the experience of symptoms in COVID-19 patients after recovery This included three parts, (a) sociodemographic characteristics (age, marital status, educational background) (b) disease-related characteristics (length of hospitalization, days following discharge, retesting positive for COVID-19, chronic disease) (c) individual factors (the main ways of acquiring knowledge of COVID-19, authenticity of optimism, the degree to which work is affected by symptoms, satisfaction with daily life). Each item was scored by the Likert 5-level scoring method, with zero representing "never" and 4 representing "always".

• Study Type: Observational
• Enrollment (Actual): 384

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Shanghai Jiaotong University School of Medicine, Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

From March to May 2022, patients treated at Shanghai Xinguo Bo Makeshift Hospital and Renji Hospital, School of Medicine, Shanghai Jiaotong University, were selected as research participants.

Description

Inclusion Criteria:

• Patients infected with COVID-19 who have been discharged from the hospital and clearly aware and able to communicate normally.

Exclusion Criteria:

• Patients who have not recovered or are still in the makeshift hospitals and those who refused to participate in the follow-up survey.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Discharge Experience Assessment Questionnaire for COVID-19 Patients and the Post Discharge Symptom Experience Risk Factor Questionnaire for COVID-19 Patients	The investigators used the Post Discharge Experience Assessment Questionnaire for COVID-19 Patients and the Post Discharge Symptom Experience Risk Factor Questionnaire for COVID-19 Patients were used.Stratified random sampling was used to conduct a cross-sectional survey of 384 patients in recovery from COVID-19.Exploratory factor analysis was used to determine the cluster of symptoms, and a binary logistic regression analysis was used to identify the risk factors associated with this symptom cluster.	up to 20 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pain; COVID-19; nervous system; sensation; disease management; respiratory system; emotions; patient discharge; nursing assessment; symptoms and signs
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: LY2022-003-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No