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

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

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Key information

Conditions

Health Education, COVID-19, Quarantine, Anxiety, Pandemic Adherence Interventions Anxiety Disorders Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Health Education Infections Lung Diseases Medication Adherence Mental Disorders Nidovirales Infections Patient Acceptance of Health Care Patient Compliance Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Treatment Adherence and Compliance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Education Intervention

Other

health education intervention

Primary outcomes

The rate of anxiety reduction

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Feb 8, 2023
Registry last updated: Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed