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An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission (TrackU)

Primary Purpose

Sars-CoV-2 Infection, Empowerment, Transmission

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Track U
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sars-CoV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Fluent in Catalan or Spanish, Resident in Catalonia, Signs informed consent, Commitment to use the tool if he/she gets in intervention group.

Exclusion Criteria:

Language barrier and other conditions that do not allow self-completion of the survey Be a COVID case or contact at the time of recruitment.

Sites / Locations

  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention : Educational tool

Control

Arm Description

self-tracking educational tool (diary)

Outcomes

Primary Outcome Measures

Risk identification of SARS-CoV 2 transmission
Risk identification of SARS-CoV 2 transmission

Secondary Outcome Measures

Empowerment in SARS-CoV 2 transmission
Empowerment in SARS-CoV 2 transmission

Full Information

First Posted
December 21, 2021
Last Updated
December 21, 2021
Sponsor
Hospital Clinic of Barcelona
Collaborators
Escoles Universitaries Gimbernat, University of Barcelona, Barcelona Institute for Global Health, Universitat Politècnica de Catalunya, Universitat Oberta de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05171829
Brief Title
An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission
Acronym
TrackU
Official Title
An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 27, 2021 (Anticipated)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Escoles Universitaries Gimbernat, University of Barcelona, Barcelona Institute for Global Health, Universitat Politècnica de Catalunya, Universitat Oberta de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
One way to empower a community, in epidemic control issues, is to know the first-hand screening tools. There are no evaluations of these home-use tools from the perspective of patient and citizen empowerment and participation. The main objective of this study is to analyze whether a self-tracking and self-tracing tool, developed in a participatory way, increases the risk identification of the disease and the empowerment in terms of risk management of transmission by the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV-2 Infection, Empowerment, Transmission

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Statistician masking
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention : Educational tool
Arm Type
Experimental
Arm Description
self-tracking educational tool (diary)
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Track U
Intervention Description
Track U diary
Primary Outcome Measure Information:
Title
Risk identification of SARS-CoV 2 transmission
Description
Risk identification of SARS-CoV 2 transmission
Time Frame
17 days
Secondary Outcome Measure Information:
Title
Empowerment in SARS-CoV 2 transmission
Description
Empowerment in SARS-CoV 2 transmission
Time Frame
17 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fluent in Catalan or Spanish, Resident in Catalonia, Signs informed consent, Commitment to use the tool if he/she gets in intervention group. Exclusion Criteria: Language barrier and other conditions that do not allow self-completion of the survey Be a COVID case or contact at the time of recruitment.
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission

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