The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients

Not Applicable

Completed

• Conditions: Health Education, COVID-19, Quarantine, Anxiety, Pandemic
• Interventions: Other: health education intervention

• Registration Number: NCT05715593
• Lead Sponsor: University of Monastir

Brief Summary

we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.

Detailed Description

This is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n=267) or control (n=269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on (D1) and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group at D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction at D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherence to preventive measures during the isolation in each group.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-07
• Status Verified: 2023-02
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

• Patients diagnosed with Covid-19 after positive PCR or positive antigen rapid test, over 18 years of age, who did not require hospitalization

Exclusion Criteria

• Patients not reachable at the first day phone call of the diagnosis and patients unable to answer the telephone questionnaire due to their cognitive state.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	health education intervention	-

Primary Outcome Measures

Name	Time	Method
The rate of anxiety reduction	One week (7 days) after the COVID 19 diagnosis	The rate of anxiety reduction in each group at Day 7 based on a HAD-A score ≥ 8

Trial Locations

Locations (1)

Fattouma Bourguiba University Hospital; 🇹🇳 Monastir, Tunisia