NCT05171829

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 21, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

December 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

5 months

First QC Date

December 21, 2021

Last Update Submit

December 21, 2021

Conditions

Sars-CoV-2 InfectionEmpowermentTransmission

Outcome Measures

Primary Outcomes (1)

  • Risk identification of SARS-CoV 2 transmission

    Risk identification of SARS-CoV 2 transmission

    17 days

Secondary Outcomes (1)

  • Empowerment in SARS-CoV 2 transmission

    17 days

Study Arms (2)

Intervention : Educational tool

EXPERIMENTAL

self-tracking educational tool (diary)

Other: Track U

Control

NO INTERVENTION

Interventions

Track UOTHER

Track U diary

Intervention : Educational tool

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

COVID-19Empowerment

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Statistician masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public Health Specialist

Study Record Dates

First Submitted

December 21, 2021

First Posted

December 29, 2021

Study Start

December 27, 2021

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

ES(1)