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| Name | Class |
|---|---|
| CW+ Charity | OTHER |
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The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SensiumVitals wearable sensor | Device | A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously. |
| Measure | Description | Time Frame |
|---|---|---|
| Deterioration Resulting in Healthcare Review | Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalisation | Deterioration resulting in hospitalisation | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ara Darzi, Prof | Institute of Global Health Innovation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33794832 | Result | Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2). BMC Public Health. 2021 Apr 1;21(1):638. doi: 10.1186/s12889-021-10660-9. | |
| 33673868 | Derived | Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2). Pilot Feasibility Stud. 2021 Mar 5;7(1):62. doi: 10.1186/s40814-021-00804-4. |
| Label | URL |
|---|---|
| Trial Protocol | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wearable Sensor | All participants had a wearable sensor applied |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Wearable Sensor | All participants had a wearable sensor applied |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Deterioration Resulting in Healthcare Review | Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation) | Posted | Number | alerts generated | 1 year |
|
|
6 weeks
0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wearable Sensor | All participants had a wearable sensor applied | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fahad Iqbal | Imperial College London | 020 3312 6666 | f.iqbal@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol | Mar 16, 2020 | Apr 24, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent form | Mar 25, 2020 | Sep 28, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Published article | View source |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Hospitalisation | Deterioration resulting in hospitalisation | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D007239 |
| Infections |