An Educational Self-tracking Tool for Identification of S... | NCT05171829

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

NCT05171829

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Dec 29, 2021Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Sars-CoV-2 Infection
Empowerment
Transmission

Interventions

Track U

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 27, 2021Estimated

Primary Completion Date

May 15, 2022Estimated

Completion Date

May 15, 2022Estimated

First Submitted Date

Dec 21, 2021

First Submission Date that Met QC Criteria

Dec 21, 2021

First Posted Date

Dec 29, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2021

Last Update Posted Date

Dec 29, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna Llupia, Public Health Specialist, Hospital Clinic of BarcelonaPrincipal Investigator

Lead Sponsor

Hospital Clinic of BarcelonaOTHER

Collaborators

Name	Class
Escoles Universitaries Gimbernat	OTHER
University of Barcelona	OTHER
Barcelona Institute for Global Health	OTHER
Universitat Politècnica de Catalunya

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention : Educational tool	Experimental	self-tracking educational tool (diary)	Other: Track U
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Track U	Other	Track U diary	Intervention : Educational tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk identification of SARS-CoV 2 transmission	Risk identification of SARS-CoV 2 transmission	17 days

Secondary Outcomes

Measure	Description	Time Frame
Empowerment in SARS-CoV 2 transmission	Empowerment in SARS-CoV 2 transmission	17 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic de Barcelona		Barcelona		08036	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D000079102	Empowerment

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided