Clinical trial NCT05556707: Symptom Clusters and Risk Factors of COVID-19 Patients
Official title: Symptom Clusters and Risk Factors of Patients Recovering From COVID-19 Caused by Omicron BA.2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Patient Discharge
Symptoms and Signs
Keywords: COVID-19
patient discharge
symptoms and signs
sensation
nervous system
emotions
respiratory system
pain
nursing assessment
disease management
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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".

Eligibility criteria: 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.

Primary outcomes:
measure: Post Discharge Experience Assessment Questionnaire for COVID-19 Patients and the Post Discharge Symptom Experience Risk Factor Questionnaire for COVID-19 Patients
timeFrame: up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
References: