<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03032887</url>
  </required_header>
  <id_info>
    <org_study_id>Hygienic voice</org_study_id>
    <nct_id>NCT03032887</nct_id>
  </id_info>
  <brief_title>Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station</brief_title>
  <official_title>Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martin-Luther-Universität Halle-Wittenberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Martin-Luther-Universität Halle-Wittenberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response&#xD;
      syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is&#xD;
      steadily rising in Germany. The hands of the staff and visitors are the most important&#xD;
      transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures&#xD;
      for the prevention of hospital infections. The different measures of hand hygiene serve to&#xD;
      protect against the spread of contamination of the skin with obligate or potentially&#xD;
      pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited&#xD;
      extent (especially in pregnant women and neonates in perinatal care centers) the primary&#xD;
      prophylactic measures are of great importance.&#xD;
&#xD;
      While the importance of hand disinfection in the staff has been undisputed, there is no data&#xD;
      on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these&#xD;
      stations are common non-compliant persons (especially children!). On the other hand, pregnant&#xD;
      women and young mothers and newborn babies are &quot;exposed&quot; to a large number of visitors&#xD;
      compared to other stations.&#xD;
&#xD;
      The investigators examine whether special measures (such as voice prompts) have a positive&#xD;
      effect on the rate of performed hand disinfections or consecutively on the infection rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total consumption of disinfectants per visitor</measure>
    <time_frame>9 months</time_frame>
    <description>Total consumption of disinfectants per visitor (electronically counted)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of highly positive Impact tests (swab tests)</measure>
    <time_frame>9 months</time_frame>
    <description>Prevalence of highly positive Impact tests (swab tests)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total consumption of disinfectants (only children) per visitor</measure>
    <time_frame>9 months</time_frame>
    <description>Total consumption of disinfectants (only children) per visitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection rate of typical maternal, fetal and newborn infections</measure>
    <time_frame>9 months</time_frame>
    <description>Infection rate of typical maternal, fetal and newborn infections</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Hygiene</condition>
  <arm_group>
    <arm_group_label>voice prompts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Agitation (education, reminders and optimising materials) plus voice prompts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no voice prompts</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>only Agitation (education, reminders and optimising materials); no voice prompts</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>voice prompts</intervention_name>
    <description>voice prompts on disinfectant dispenser</description>
    <arm_group_label>voice prompts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>agitation</intervention_name>
    <description>Education, reminders and optimising materials</description>
    <arm_group_label>no voice prompts</arm_group_label>
    <arm_group_label>voice prompts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age: 7 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  Member of target group: Visitor or staff&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient language skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg</name>
      <address>
        <city>Halle (Saale)</city>
        <state>Sachsen-Anhalt</state>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21864941</PMID>
  </reference>
  <reference>
    <citation>Tromp 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.</citation>
    <PMID>22285710</PMID>
  </reference>
  <reference>
    <citation>Swoboda 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.</citation>
    <PMID>17765560</PMID>
  </reference>
  <reference>
    <citation>Huis 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.</citation>
    <PMID>22978722</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Martin-Luther-Universität Halle-Wittenberg</investigator_affiliation>
    <investigator_full_name>Gregor Seliger</investigator_full_name>
    <investigator_title>Chief resident</investigator_title>
  </responsible_party>
  <keyword>hygiene</keyword>
  <keyword>prenatal care</keyword>
  <keyword>postnatal care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03032887
org study id: Hygienic voice
nct id: NCT03032887
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Total consumption of disinfectants per visitor
time frame: 9 months
description: Total consumption of disinfectants per visitor (electronically counted)
measure: Prevalence of highly positive Impact tests (swab tests)
time frame: 9 months
description: Prevalence of highly positive Impact tests (swab tests)
measure: Total consumption of disinfectants (only children) per visitor
time frame: 9 months
description: Total consumption of disinfectants (only children) per visitor
measure: Infection rate of typical maternal, fetal and newborn infections
time frame: 9 months
description: Infection rate of typical maternal, fetal and newborn infections
arm group label: voice prompts
arm group type: Experimental
description: Agitation (education, reminders and optimising materials) plus voice prompts
arm group label: no voice prompts
arm group type: Other
description: only Agitation (education, reminders and optimising materials); no voice prompts
intervention type: Behavioral
intervention name: voice prompts
description: voice prompts on disinfectant dispenser
arm group label: voice prompts
intervention type: Behavioral
intervention name: agitation
description: Education, reminders and optimising materials
arm group label: no voice prompts
arm group label: voice prompts
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
citation: 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.
PMID: 21864941
citation: Tromp 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.
PMID: 22285710
citation: Swoboda 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.
PMID: 17765560
citation: Huis 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.
PMID: 22978722
responsible party type: Principal Investigator
investigator affiliation: Martin-Luther-Universität Halle-Wittenberg
investigator full name: Gregor Seliger
investigator title: Chief resident
mesh term: Infections
sharing ipd: Undecided