- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05715593
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients
February 3, 2023 updated by: Imen Zemni, University of Monastir
The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial
we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
402
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Monastir, Tunisia, 5000
- Fattouma Bourguiba University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
EXPERIMENTAL: Education
|
health education intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One week (7 days) after the COVID 19 diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2021
Primary Completion (ACTUAL)
June 30, 2021
Study Completion (ACTUAL)
July 7, 2021
Study Registration Dates
First Submitted
February 3, 2023
First Submitted That Met QC Criteria
February 3, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMONASTIR1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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