- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05171829
An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission (TrackU)
December 21, 2021 updated by: Anna Llupia, Hospital Clinic of Barcelona
An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission: a Randomised Controlled Trial
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
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
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
-
-
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
Yes
Genders Eligible for Study
All
Description
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.
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Intervention : Educational tool
self-tracking educational tool (diary)
|
Track U diary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk identification of SARS-CoV 2 transmission
Time Frame: 17 days
|
Risk identification of SARS-CoV 2 transmission
|
17 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Empowerment in SARS-CoV 2 transmission
Time Frame: 17 days
|
Empowerment in SARS-CoV 2 transmission
|
17 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
December 27, 2021
Primary Completion (Anticipated)
May 15, 2022
Study Completion (Anticipated)
May 15, 2022
Study Registration Dates
First Submitted
December 21, 2021
First Submitted That Met QC Criteria
December 21, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
December 21, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCB/2021/1054
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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