NCT05715593

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

February 3, 2023

Last Update Submit

February 3, 2023

Conditions

Health Education, COVID-19, Quarantine, Anxiety, Pandemic

Outcome Measures

Primary Outcomes (1)

  • The rate of anxiety reduction

    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

Study Arms (2)

Education

EXPERIMENTAL
Other: health education intervention

Control

NO INTERVENTION

Interventions

health education interventionOTHER

health education intervention

Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

Location

Related Publications (1)

  • Zemni I, Gara A, Nasraoui H, Kacem M, Maatouk A, Trimeche O, Abroug H, Fredj MB, Bennasrallah C, Dhouib W, Bouanene I, Belguith AS. The effectiveness of a health education intervention to reduce anxiety in quarantined COVID-19 patients: a randomized controlled trial. BMC Public Health. 2023 Jun 20;23(1):1188. doi: 10.1186/s12889-023-16104-w.

    PMID: 37340300DERIVED

MeSH Terms

Conditions

Health EducationCOVID-19Anxiety Disorders

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 8, 2023

Study Start

February 1, 2021

Primary Completion

June 30, 2021

Study Completion

July 7, 2021

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

TU(1)