Clinical trial NCT04638738: Outcomes of Digital Alerting Systems in Secondary Care
Official title: Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: a Prospective Evaluation of Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Deterioration, Clinical
Keywords: vital signs
continuous monitoring
wearable sensor
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults admitted to general wards who will be staying at least 24h within hospital.

Brief summary: Why? The investigators are trying to find out if participants that suddenly deteriorate on the ward can be identified sooner by wearing a wearable sensor. This is an important study to see if the sensor works correctly in recording continuous vital observations of heart rate, respiratory rate and temperature. This information can help doctors and nurses identify un-well participants.

What? The investigators will ask the participants to wear a light wearable sensor on the chest that can be worn for 5 days. If the participants are still in hospital after this time the sensor can be changed. All sensors are disposable. The participants would not have to actively do anything to the sensor. We will also participants to complete a short questionnaire about the sensor.

Who? All participants on the ward that are admitted with a new medical or surgical problem can take part in the study. Participants undergoing a surgical procedure that require at least one overnight stay are eligible to take part in this study.

Where? This study is being conducted at West Middlesex University Hospital and St Marys Hospital Paddington. Only certain wards are being included at both sites, if the participant moves wards the sensor will be removed.

How? The study will last around 5 years and we aim to recruit 1000 participants.


Eligibility criteria: Inclusion Criteria:

* Admitted adults on a general medical or surgical ward, identified as suitable by the clinical team.
* Able to provide written consent

Exclusion Criteria:

* pacemaker/ICD
* open chest wound injury
* skin condition preventing sensor to be worn
* participant whom withdraws consent

Primary outcomes:
measure: Time to acknowledge alert
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Hospital length of stay
timeFrame: through study completion, an average of 1 year
measure: Mortality
timeFrame: through study completion, an average of 1 year
measure: Hospital readmissions
timeFrame: through study completion, an average of 1 year
measure: intensive care step up
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: West Middlesex University Hospital
Study officials:
affiliation: Honorary research fellow
name: Meera Joshi, MRCS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iqbal FM, Joshi M, Fox R, Koutsoukou T, Sharma A, Wright M, Khan S, Ashrafian H, Darzi A. Outcomes of Vital Sign Monitoring of an Acute Surgical Cohort With Wearable Sensors and Digital Alerting Systems: A Pragmatically Designed Cohort Study and Propensity-Matched Analysis. Front Bioeng Biotechnol. 2022 Jun 27;10:895973. doi: 10.3389/fbioe.2022.895973. eCollection 2022.
citation: Joshi M, Ashrafian H, Arora S, Sharabiani M, McAndrew K, Khan SN, Cooke GS, Darzi A. A pilot study to investigate real-time digital alerting from wearable sensors in surgical patients. Pilot Feasibility Stud. 2022 Jul 6;8(1):140. doi: 10.1186/s40814-022-01084-2.
citation: Iqbal FM, Joshi M, Khan S, Ashrafian H, Darzi A. Implementation of Wearable Sensors and Digital Alerting Systems in Secondary Care: Protocol for a Real-World Prospective Study Evaluating Clinical Outcomes. JMIR Res Protoc. 2021 May 4;10(5):e26240. doi: 10.2196/26240.