Activity, MotorNCT03277118
Quantifying Activity Using Wireless Wearable Technology
An observational study of Activity, Motor and Sleep, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Activity, Motor, Sleep, Delirium
- What is being tested?
- Wireless Wearable Device
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2017to 18 Aug 2019
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT Southwestern Medical Center.
Who may be able to join
- Inclusion Criteria: Adult (Age > 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass
Who cannot join
- Those who do not meet the inclusion criteria, pregnant women, prisoners, those with skin or systemic infections, those who are paraplegic or quadriplegic and those with allergies to the polyurethane material comprising the FitBit strap.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology
Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.
Read the detailed description
In this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the IRB until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. No identifiable patient information will be entered into the smartphone application or transmitted to any external entity.
- Conditions
- Activity, Motor, Sleep, Delirium
- Being tested
- Wireless Wearable Device
- Medical subject headings
- Motor Activity, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Wearable DeviceDevice
Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Cohort | Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass. Receives: Device: Wireless Wearable Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps walked
Number of steps walked as measured by the Wireless Wearable Device
Measured: Postoperative day 2 to Postoperative day 5
Secondary outcomes (2)
Length of sleep
Number of hours slept with little activity as measured by the Wireless Wearable Device
Measured: Postoperative Day 1
Delirium
Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device
Measured: Postoperative Day 2 (after extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start18 Apr 2017
- Primary completion18 Aug 2019
- Study completion18 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sreekanth Cheruku, University of Texas Southwestern Medical Center
- Investigators
- Sreekanth Cheruku, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277118
- Sponsor's protocol ID
- STU 032017-102
- Status last verified
- Oct 2019
- First submitted
- 17 May 2017
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology
- ClinicalTrials.gov ID
- NCT03277118
- Acronym / sponsor ID
- STU 032017-102
- Conditions
- Activity, Motor, Sleep, Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 18 Aug 2019 (actual)
- Study completion
- 18 Aug 2019 (actual)
- First posted
- 8 Sep 2017 (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.
Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.
Detailed description
In this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the IRB until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. No identifiable patient information will be entered into the smartphone application or transmitted to any external entity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery Cohort | – | Device: Wireless Wearable DevicePatients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT Southwestern Medical Center.
Key inclusion criteria (1 listed)
- Inclusion Criteria: Adult (Age > 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Those who do not meet the inclusion criteria, pregnant women, prisoners, those with skin or systemic infections, those who are paraplegic or quadriplegic and those with allergies to the polyurethane material comprising the FitBit strap.
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 |
|---|---|---|
| Wireless Wearable DeviceWireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality. | Device | Cardiac Surgery Cohort |
Primary outcome
Number of steps walked
Time frame: Postoperative day 2 to Postoperative day 5
Number of steps walked as measured by the Wireless Wearable Device
2 secondary outcomes
Length of sleep
Time frame: Postoperative Day 1
Delirium
Time frame: Postoperative Day 2 (after extubation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Sreekanth Cheruku, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Activity, Motor and Sleep, run by University of Texas Southwestern Medical Center at 1 site in United States.
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: finished, as of the sponsor's last update on 3 Oct 2019. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of steps walked (time frame: Postoperative day 2 to Postoperative day 5). 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 3 Oct 2019.