Hand HygieneSHHRINCT03948672
CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection
A study testing CleanHands System in people with Hand Hygiene and Infection, run by Microsensor Labs LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine if use of the CleanHands system can improve hand hygiene/personal protective equipment (PPE) compliance and reduce infections in the hospital ICUs through reminders to wash hands and use PPE as appropriate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Hygiene, Infection
- What is being tested?
- CleanHands System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to 29 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All nurses, attending physicians, resident physicians, housecleaning staff, medical assistants, respiratory therapists, laboratory personnel (lab drawing) within experiment units.
- At least 18 years old
- Consent to participate in this study
Who cannot join
- Refusal to participate in this study
- Any reason that makes the participant not able to wear the CleanHands wristband
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Health
Louisville, Kentucky, 40202
About this study
Official title: CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection Trial
The purpose of this study is to determine if use of the CleanHands system can improve hand hygiene/personal protective equipment (PPE) compliance and reduce infections in the hospital ICUs through reminders to wash hands and use PPE as appropriate.
Read the detailed description
Experimental design: The investigators plan to perform a randomized cross-over study at University of Louisville Hospital (ULH) ICUs from July 2019 to June 2020. The study will be submitted to the University of Louisville IRB for approval before any study activities are started.
Performance Site: University of Louisville Hospital. The ICU departments will be randomized to participate in either one of the two research arms: control-then-intervention arm or intervention-then-control arm.
Participants: All nurses, attending physicians, resident physicians, housecleaning staff, medical assistants, respiratory therapists, laboratory personnel (lab drawing) within experiment units.
Control-then-Intervention arm: In each intensive care unit assigned to the Control-then-Intervention arm, all participants who regularly access the ICUs will wear the wristband while at work for 5 months. The functionality of the wristband will not be disclosed to the healthcare providers. Handwashing compliance data will be automatically collected, but data will not be shared with the healthcare providers or hospital management teams. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from the sensor system. Then, all healthcare providers will be educated on the functionalities of the CleanHands system with real time reminders now turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection reduction. This phase will last for 5 months. All personnel will be educated not to discuss the functionalities of CleanHands system with their co-workers to ensure adequate blinding.
Intervention-then-Control arm: In each intensive care unit assigned to the Intervention-then-Control arm, all participants who regularly access to the ICUs will be educated on the functionalities of the CleanHands system with real time reminders turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection control. This phase will last for 5 months. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from sensor system installation and implementation. Then, the real-time reminder functionality of the wristband will be turned off and no more education will be provided. Handwashing compliance data will be automatically collected but will not be shared with the healthcare providers. The unit manager and hospital administrators will now be blinded to the handwashing compliance results. This process will last for 5 months.
Data collection: Handwashing compliance data are automatically collected by CleanHands. These data include all handwashing opportunities (defined as when a wristband is in pre-set proximity of the controller for 5 seconds or more), total cleaning solution dispensing counts, rates of
- Conditions
- Hand Hygiene, Infection
- Being tested
- CleanHands System
- Keywords
- hand hygiene, infection, sensor
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanHands SystemDevice
All participants who regularly access the ICUs will wear the CleanHands system wristband while at work for 5 months and the reminding functionality is turned on.
| Study group | Role | What they receive |
|---|---|---|
| Control-then-Intervention | Active comparator | In each intensive care unit assigned to the Control-then-Intervention arm, all participants who regularly access the ICUs will wear the wristband while at work for 5 months. The functionality of the wristband will not be disclosed to the healthcare providers. Handwashing compliance data will be automatically collected, but data will not be shared with the healthcare providers or hospital management teams. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from the sensor system. Then, all healthcare providers will be educated on the functionalities of the CleanHands system with real time reminders now turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection reduction. This phase will last for 5 months. Receives: Device: CleanHands System |
| Intervention-then-Control | Active comparator | In each intensive care unit assigned to the Intervention-then-Control arm, all participants who regularly access to the ICUs will be educated on the functionalities of the CleanHands system with real time reminders turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection control. This phase will last for 5 months. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from sensor system installation and implementation. Then, the real-time reminder functionality of the wristband will be turned off and no more education will be provided. Handwashing compliance data will be automatically collected but will not be shared with the healthcare providers. This process will last for 5 months. Receives: Device: CleanHands System |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand hygiene compliance rate
percentage of qualified hand hygiene events divided by total hand hygiene opportunities.
Measured: 12 months
Secondary outcomes (1)
ICU infection rates
Catheter Associated Urinary Tract Infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), C Diff, Bloodstream MRSA, Surgical Site Infection (SSI), Vancomycin Resistant Enterococcus (VRE), multiple drug resistant pseudomonas, Acinetobacter, Enterobacteriaceae, Carbapenem Resistant Enterobacteriaceae (CRE), and Carbapenem Resistant Organisms (CRO) rates.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start7 Oct 2020
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand HygieneStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Randomized, single blinded, crossover clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microsensor Labs LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of Louisville, University of Chicago, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jiapeng Huang, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948672
- Sponsor's protocol ID
- 19.001
- Other IDs
- 4R44AG060848-02
- Acronym
- SHHRI
- Status last verified
- Nov 2022
- First submitted
- 10 May 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD.
Publications
Xu Q, Liu Y, Cepulis D, Jerde A, Sheppard RA, Reichle W, Scott L, Oppy L, Stevenson G, Bishop S, Clifford SP, Liu P, Kong M, Huang J. Hand hygiene behaviours monitored by an electronic system in the intensive care unit - a prospective observational study. J Hosp Infect. 2022 May;123:126-134. doi: 10.1016/j.jhin.2022.01.017. Epub 2022 Feb 2.
PubMed 35122887
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CleanHands Sensor Based System to Improve Hand Hygiene and Reduce Infection Trial
- ClinicalTrials.gov ID
- NCT03948672
- Acronym / sponsor ID
- SHHRI / 19.001
- Conditions
- Hand Hygiene, Infection
- Keywords
- hand hygiene, infection, sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Microsensor Labs LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), University of Louisville, University of Chicago, National Institute on Aging (NIA)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 14 May 2019 (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.
The purpose of this study is to determine if use of the CleanHands system can improve hand hygiene/personal protective equipment (PPE) compliance and reduce infections in the hospital ICUs through reminders to wash hands and use PPE as appropriate.
Detailed description
Experimental design: The investigators plan to perform a randomized cross-over study at University of Louisville Hospital (ULH) ICUs from July 2019 to June 2020. The study will be submitted to the University of Louisville IRB for approval before any study activities are started.
Performance Site: University of Louisville Hospital. The ICU departments will be randomized to participate in either one of the two research arms: control-then-intervention arm or intervention-then-control arm.
Participants: All nurses, attending physicians, resident physicians, housecleaning staff, medical assistants, respiratory therapists, laboratory personnel (lab drawing) within experiment units.
Control-then-Intervention arm: In each intensive care unit assigned to the Control-then-Intervention arm, all participants who regularly access the ICUs will wear the wristband while at work for 5 months. The functionality of the wristband will not be disclosed to the healthcare providers. Handwashing compliance data will be automatically collected, but data will not be shared with the healthcare providers or hospital management teams. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from the sensor system. Then, all healthcare providers will be educated on the functionalities of the CleanHands system with real time reminders now turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection reduction. This phase will last for 5 months. All personnel will be educated not to discuss the functionalities of CleanHands system with their co-workers to ensure adequate blinding.
Intervention-then-Control arm: In each intensive care unit assigned to the Intervention-then-Control arm, all participants who regularly access to the ICUs will be educated on the functionalities of the CleanHands system with real time reminders turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection control. This phase will last for 5 months. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from sensor system installation and implementation. Then, the real-time reminder functionality of the wristband will be turned off and no more education will be provided. Handwashing compliance data will be automatically collected but will not be shared with the healthcare providers. The unit manager and hospital administrators will now be blinded to the handwashing compliance results. This process will last for 5 months.
Data collection: Handwashing compliance data are automatically collected by CleanHands. These data include all handwashing opportunities (defined as when a wristband is in pre-set proximity of the controller for 5 seconds or more), total cleaning solution dispensing counts, rates of
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single blinded, crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control-then-Intervention | Active comparator | Device: CleanHands SystemIn each intensive care unit assigned to the Control-then-Intervention arm, all participants who regularly access the ICUs will wear the wristband while at work for 5 months. The functionality of the wristband will not be disclosed to the healthcare providers. Handwashing compliance data will be automatically collected, but data will not be shared with the healthcare providers or hospital management teams. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from the sensor system. Then, all healthcare providers will be educated on the functionalities of the CleanHands system with real time reminders now turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection reduction. This phase will last for 5 months. |
| Intervention-then-Control | Active comparator | Device: CleanHands SystemIn each intensive care unit assigned to the Intervention-then-Control arm, all participants who regularly access to the ICUs will be educated on the functionalities of the CleanHands system with real time reminders turned on. Healthcare providers will then have access to their own and unit-specific handwashing data. The unit manager and hospital administrators will be able to access all of these data and advanced analysis to make management decisions on infection control. This phase will last for 5 months. After 5 months, a washout period of 2 months will be introduced to eliminate potential influences on healthcare providers' behaviors from sensor system installation and implementation. Then, the real-time reminder functionality of the wristband will be turned off and no more education will be provided. Handwashing compliance data will be automatically collected but will not be shared with the healthcare providers. This process will last for 5 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All nurses, attending physicians, resident physicians, housecleaning staff, medical assistants, respiratory therapists, laboratory personnel (lab drawing) within experiment units.
- At least 18 years old
- Consent to participate in this study
Key exclusion criteria (2 listed)
- Refusal to participate in this study
- Any reason that makes the participant not able to wear the CleanHands wristband
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 |
|---|---|---|
| CleanHands SystemAll participants who regularly access the ICUs will wear the CleanHands system wristband while at work for 5 months and the reminding functionality is turned on. | Device | Control-then-Intervention, Intervention-then-Control |
Primary outcome
hand hygiene compliance rate
Time frame: 12 months
percentage of qualified hand hygiene events divided by total hand hygiene opportunities.
1 secondary outcome
ICU infection rates
Time frame: 12 months
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 15 Nov 2022.
- Derived from this study: PubMed 35122887Xu Q, Liu Y, Cepulis D, Jerde A, Sheppard RA, Reichle W, Scott L, Oppy L, Stevenson G, Bishop S, Clifford SP, Liu P, Kong M, Huang J. Hand hygiene behaviours monitored by an electronic system in the intensive care unit - a prospective observational study. J Hosp Infect. 2022 May;123:126-134. doi: 10.1016/j.jhin.2022.01.017. Epub 2022 Feb 2.
- Individual participant dataSharing planned: No. There is no plan to share IPD.
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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.
Jiapeng Huang, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CleanHands System in people with Hand Hygiene and Infection, run by Microsensor Labs LLC 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 3 inclusion and 2 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 15 Nov 2022. 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?
hand hygiene compliance rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948672, which also lists 1 linked publication.
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 15 Nov 2022.