Sars-CoV-2 InfectionTrackUNCT05171829
An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission
A study testing Track U in people with Sars-CoV-2 Infection and Empowerment, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV-2 Infection, Empowerment, Transmission
- What is being tested?
- Track U
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 27 Dec 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in Catalan or Spanish, Resident in Catalonia, Signs informed consent, Commitment to use the tool if he/she gets in intervention group.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sars-CoV-2 Infection, Empowerment, Transmission
- Being tested
- Track U
- Medical subject headings
- COVID-19, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Track UOther
Track U diary
| Study group | Role | What they receive |
|---|---|---|
| Intervention : Educational tool | Experimental | self-tracking educational tool (diary) Receives: Other: Track U |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk identification of SARS-CoV 2 transmission
Risk identification of SARS-CoV 2 transmission
Measured: 17 days
Secondary outcomes (1)
Empowerment in SARS-CoV 2 transmission
Empowerment in SARS-CoV 2 transmission
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start27 Dec 2021 (estimated)
- Primary completion15 May 2022 (estimated)
- Study completion15 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Escoles Universitaries Gimbernat, University of Barcelona, Barcelona Institute for Global Health, Universitat Politècnica de Catalunya, Universitat Oberta de Catalunya
- Responsible party
- Principal investigator, Anna Llupia, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171829
- Sponsor's protocol ID
- HCB/2021/1054
- Acronym
- TrackU
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Educational Self-tracking Tool for Identification of SARS-CoV-2 Risk Transmission: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05171829
- Acronym / sponsor ID
- TrackU / HCB/2021/1054
- Conditions
- Sars-CoV-2 Infection, Empowerment, Transmission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Escoles Universitaries Gimbernat, University of Barcelona, Barcelona Institute for Global Health, Universitat Politècnica de Catalunya, Universitat Oberta de Catalunya
- Study start
- 27 Dec 2021 (estimated)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 15 May 2022 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention : Educational tool | Experimental | Other: Track Uself-tracking educational tool (diary) |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fluent in Catalan or Spanish, Resident in Catalonia, Signs informed consent, Commitment to use the tool if he/she gets in intervention group.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Track UTrack U diary | Other | Intervention : Educational tool |
Primary outcome
Risk identification of SARS-CoV 2 transmission
Time frame: 17 days
Risk identification of SARS-CoV 2 transmission
1 secondary outcome
Empowerment in SARS-CoV 2 transmission
Time frame: 17 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Track U in people with Sars-CoV-2 Infection and Empowerment, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk identification of SARS-CoV 2 transmission (time frame: 17 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.