The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients
Primary Purpose
Health Education, COVID-19, Quarantine, Anxiety, Pandemic
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
health education intervention
Sponsored by
About this trial
This is an interventional prevention trial for Health Education, COVID-19, Quarantine, Anxiety, Pandemic
Eligibility Criteria
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.
Sites / Locations
- Fattouma Bourguiba University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Education
Control
Arm Description
Outcomes
Primary Outcome Measures
The rate of anxiety reduction
The rate of anxiety reduction in each group at Day 7 based on a HAD-A score ≥ 8
Secondary Outcome Measures
Full Information
NCT ID
NCT05715593
First Posted
February 3, 2023
Last Updated
February 3, 2023
Sponsor
University of Monastir
1. Study Identification
Unique Protocol Identification Number
NCT05715593
Brief Title
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients
Official Title
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Education, COVID-19, Quarantine, Anxiety, Pandemic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
health education intervention
Intervention Description
health education intervention
Primary Outcome Measure Information:
Title
The rate of anxiety reduction
Description
The rate of anxiety reduction in each group at Day 7 based on a HAD-A score ≥ 8
Time Frame
One week (7 days) after the COVID 19 diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients
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