HygieneNCT03032887
Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station
A study testing voice prompts and agitation in people with Hygiene, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hygiene
- What is being tested?
- voice prompts and agitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Apr 2019
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Minimum age: 7 years
- informed consent
- Member of target group: Visitor or staff
Who cannot join
- Insufficient language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site
Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, 06120
About this study
Official title: Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations
The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures for the prevention of hospital infections. The different measures of hand hygiene serve to protect against the spread of contamination of the skin with obligate or potentially pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited extent (especially in pregnant women and neonates in perinatal care centers) the primary prophylactic measures are of great importance.
While the importance of hand disinfection in the staff has been undisputed, there is no data on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these stations are common non-compliant persons (especially children!). On the other hand, pregnant women and young mothers and newborn babies are "exposed" to a large number of visitors compared to other stations.
The investigators examine whether special measures (such as voice prompts) have a positive effect on the rate of performed hand disinfections or consecutively on the infection rate.
- Conditions
- Hygiene
- Being tested
- voice prompts, agitation
- Keywords
- hygiene, prenatal care, postnatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voice promptsBehavioural
voice prompts on disinfectant dispenser
agitationBehavioural
Education, reminders and optimising materials
| Study group | Role | What they receive |
|---|---|---|
| voice prompts | Experimental | Agitation (education, reminders and optimising materials) plus voice prompts Receives: Behavioral: voice prompts; Behavioral: agitation |
| no voice prompts | Other | only Agitation (education, reminders and optimising materials); no voice prompts Receives: Behavioral: agitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of disinfectants per visitor
Total consumption of disinfectants per visitor (electronically counted)
Measured: 9 months
Secondary outcomes (3)
Prevalence of highly positive Impact tests (swab tests)
Prevalence of highly positive Impact tests (swab tests)
Measured: 9 months
Total consumption of disinfectants (only children) per visitor
Total consumption of disinfectants (only children) per visitor
Measured: 9 months
Infection rate of typical maternal, fetal and newborn infections
Infection rate of typical maternal, fetal and newborn infections
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032887
- Sponsor's protocol ID
- Hygienic voice
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Birnbach DJ, Nevo I, Barnes S, Fitzpatrick M, Rosen LF, Everett-Thomas R, Sanko JS, Arheart KL. Do hospital visitors wash their hands? Assessing the use of alcohol-based hand sanitizer in a hospital lobby. Am J Infect Control. 2012 May;40(4):340-3. doi: 10.1016/j.ajic.2011.05.006. Epub 2011 Aug 23.
PubMed 21864941Tromp M, Huis A, de Guchteneire I, van der Meer J, van Achterberg T, Hulscher M, Bleeker-Rovers C. The short-term and long-term effectiveness of a multidisciplinary hand hygiene improvement program. Am J Infect Control. 2012 Oct;40(8):732-6. doi: 10.1016/j.ajic.2011.09.009. Epub 2012 Jan 30.
PubMed 22285710Swoboda SM, Earsing K, Strauss K, Lane S, Lipsett PA. Isolation status and voice prompts improve hand hygiene. Am J Infect Control. 2007 Sep;35(7):470-6. doi: 10.1016/j.ajic.2006.09.009.
PubMed 17765560Huis A, van Achterberg T, de Bruin M, Grol R, Schoonhoven L, Hulscher M. A systematic review of hand hygiene improvement strategies: a behavioural approach. Implement Sci. 2012 Sep 14;7:92. doi: 10.1186/1748-5908-7-92.
PubMed 22978722
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations
- ClinicalTrials.gov ID
- NCT03032887
- Acronym / sponsor ID
- Hygienic voice
- Conditions
- Hygiene
- Keywords
- hygiene, prenatal care, postnatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures for the prevention of hospital infections. The different measures of hand hygiene serve to protect against the spread of contamination of the skin with obligate or potentially pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited extent (especially in pregnant women and neonates in perinatal care centers) the primary prophylactic measures are of great importance.
While the importance of hand disinfection in the staff has been undisputed, there is no data on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these stations are common non-compliant persons (especially children!). On the other hand, pregnant women and young mothers and newborn babies are "exposed" to a large number of visitors compared to other stations.
The investigators examine whether special measures (such as voice prompts) have a positive effect on the rate of performed hand disinfections or consecutively on the infection rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| voice prompts | Experimental | Behavioral: voice prompts, Behavioral: agitationAgitation (education, reminders and optimising materials) plus voice prompts |
| no voice prompts | Other | Behavioral: agitationonly Agitation (education, reminders and optimising materials); no voice prompts |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum age: 7 years
- informed consent
- Member of target group: Visitor or staff
Key exclusion criteria (1 listed)
- Insufficient language skills
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 |
|---|---|---|
| voice promptsvoice prompts on disinfectant dispenser | Behavioural | voice prompts |
| agitationEducation, reminders and optimising materials | Behavioural | no voice prompts, voice prompts |
Primary outcome
Total consumption of disinfectants per visitor
Time frame: 9 months
Total consumption of disinfectants per visitor (electronically counted)
3 secondary outcomes
Prevalence of highly positive Impact tests (swab tests)
Time frame: 9 months
Total consumption of disinfectants (only children) per visitor
Time frame: 9 months
Infection rate of typical maternal, fetal and newborn infections
Time frame: 9 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 17 Apr 2019.
- Background: PubMed 21864941Birnbach DJ, Nevo I, Barnes S, Fitzpatrick M, Rosen LF, Everett-Thomas R, Sanko JS, Arheart KL. Do hospital visitors wash their hands? Assessing the use of alcohol-based hand sanitizer in a hospital lobby. Am J Infect Control. 2012 May;40(4):340-3. doi: 10.1016/j.ajic.2011.05.006. Epub 2011 Aug 23.
- Background: PubMed 22285710Tromp M, Huis A, de Guchteneire I, van der Meer J, van Achterberg T, Hulscher M, Bleeker-Rovers C. The short-term and long-term effectiveness of a multidisciplinary hand hygiene improvement program. Am J Infect Control. 2012 Oct;40(8):732-6. doi: 10.1016/j.ajic.2011.09.009. Epub 2012 Jan 30.
- Background: PubMed 17765560Swoboda SM, Earsing K, Strauss K, Lane S, Lipsett PA. Isolation status and voice prompts improve hand hygiene. Am J Infect Control. 2007 Sep;35(7):470-6. doi: 10.1016/j.ajic.2006.09.009.
- Background: PubMed 22978722Huis A, van Achterberg T, de Bruin M, Grol R, Schoonhoven L, Hulscher M. A systematic review of hand hygiene improvement strategies: a behavioural approach. Implement Sci. 2012 Sep 14;7:92. doi: 10.1186/1748-5908-7-92.
- 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 voice prompts and agitation in people with Hygiene, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 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 17 Apr 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 Germany. 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?
Total consumption of disinfectants per visitor (time frame: 9 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 NCT03032887, which also lists 4 linked publications.
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 17 Apr 2019.