<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/NCT03030144</url>
  </required_header>
  <id_info>
    <org_study_id>29-007 ex 16/17</org_study_id>
    <nct_id>NCT03030144</nct_id>
  </id_info>
  <brief_title>P-INC: Project Incontinence- Effectiveness of Nursing Recommendations</brief_title>
  <official_title>Effectiveness of Nursing Recommendations for the Management of Urinary Incontinence in Nursing Homes: a Cluster-randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The international literature emphasizes the vast benefits of the effective implementation of&#xD;
      evidence based nursing recommendations in improving patient care processes and enhancing&#xD;
      health outcomes. The key role of nurses in the prevention, treatment and care of incontinence&#xD;
      is highlighted. Studies have shown that UI is a neglected nursing care problem in Austria&#xD;
      e.g. regarding diagnosis and nursing interventions. Nursing recommendations may enhance the&#xD;
      frequency of diagnosis, the use of nursing interventions as well as decrease the frequency of&#xD;
      daily UI in nursing home residents. Beside that little is known about nursing recommendations&#xD;
      implementation regarding urinary incontinence in the nursing home setting, especially in the&#xD;
      Austrian context.&#xD;
&#xD;
      The aim of this study is to measure the effectiveness of the implementation of evidence based&#xD;
      nursing recommendations regarding UI in Austrian nursing homes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to measure the effectiveness of the implementation of evidence based&#xD;
      nursing recommendations regarding UI in Austrian nursing homes, including three research&#xD;
      questions:&#xD;
&#xD;
        1. What is the statistical difference between the frequency of daily UI in nursing home&#xD;
           residents in the intervention group when compared to the control group?&#xD;
&#xD;
        2. What is the statistical difference between the frequency of documented categorisation of&#xD;
           UI (UI diagnosis) in the intervention group (implementation of the nursing&#xD;
           recommendations) compared to the control group (standard care)?&#xD;
&#xD;
        3. What is the statistical difference between the amounts of used nursing interventions in&#xD;
           the intervention group compared to the control group?&#xD;
&#xD;
      5. Methods 5.1. Design A three-month cluster-randomized trial will be conducted in nursing&#xD;
      homes in Styria and Carinthia.&#xD;
&#xD;
      5.2. Setting All nursing homes in Styria and Carinthia with a capacity ≥ 50 beds registered&#xD;
      in a national database [15] will be invited to participate by means of an information flyer&#xD;
      and email. With regards to practicability invitation will be started with those nursing homes&#xD;
      with the highest number of beds.&#xD;
&#xD;
      5.3. Sample Currently there are 176 nursing homes in Styria and Carinthia with a capacity ≥&#xD;
      50 beds registered in a national database with a total of 15208 nursing home residents.&#xD;
      Through experiences from former projects a low response rate is expected. We assume a&#xD;
      response rate of 2% on the nursing home level, amounting to 3 participating nursing homes&#xD;
      with 259 residents. Nursing homes that want to participate voluntarily will be contacted via&#xD;
      telephone starting at the largest for further inclusion criteria.&#xD;
&#xD;
      Inclusion criteria for nursing home residents are living in the nursing home at the date of&#xD;
      baseline measurement and being female and assumed to stay for the whole duration of the study&#xD;
      (3 months). Written informed consent from the participating residents or their legal&#xD;
      representatives is required.&#xD;
&#xD;
      The nursing interventions are made for women, so we have to focus our sample to women. In&#xD;
      Austrian nursing homes about 70% are women.Which means we have a total of 181 female nursing&#xD;
      home residents that can be asked for participation.&#xD;
&#xD;
      We know from former studies that 90% of nursing home residents are able and willing to&#xD;
      participate in a research study, amounting to an expected total of 163 participants in the 3&#xD;
      remaining nursing homes. We assume that 10% of the residents drop out during the study&#xD;
      period. Therefore 147 female residents in the 3 nursing homes are basis for our calculation.&#xD;
&#xD;
      These 3 nursing homes will be randomly assigned (eg. via &quot;Randomizer&quot;) to the intervention&#xD;
      group and to the control group.&#xD;
&#xD;
      An Intra Class Coefficient (ICC) 0.05 was assumed from the literature. With the &quot;Sample Size&#xD;
      Calculator&quot; developed by Campbell et al. (2004) the detectable difference with these fixed&#xD;
      sample sizes was calculated.&#xD;
&#xD;
      With an expected cluster size of 49 nursing home residents in 3 clusters and a power of 80 %&#xD;
      and a significance level of 0.05 we expect a minimum decrease in the frequency of daily UI&#xD;
      from 90% to 55%.&#xD;
&#xD;
      6.0 Ethical considerations This study will be conducted in line with the declaration of&#xD;
      Helsinki and the &quot;Good scientific practice&quot; of the Medical University of Graz. Nursing homes&#xD;
      can withdraw their participation without stating reasons via telephone and email. Informed&#xD;
      consent will be obtained of all participating residents. Residents can withdraw anytime in&#xD;
      the study without stating reasons.&#xD;
&#xD;
      The questionnaire is based on the routine nursing care interventions and data regarding UI.&#xD;
      Therefore no risk or side effects for the participating residents are expected. Nursing homes&#xD;
      in the control group receive the nursing recommendations after the three month study period.&#xD;
&#xD;
      In this study only data will be collected. Therefore names of the residents cannot be traced.&#xD;
&#xD;
      7.0 Data collection including instruments Baseline measurement: The baseline measurement will&#xD;
      be conducted to gather data on resident level (Table 1).&#xD;
&#xD;
      Table 1: Collected baseline data including time Collected data Collection time Purpose&#xD;
&#xD;
        -  Participation Baseline&#xD;
&#xD;
        -  Age Baseline Comparing residents&#xD;
&#xD;
        -  Diagnosis Dementia Baseline Comparing residents&#xD;
&#xD;
        -  Care dependency Baseline/6weeks/month Comparing residents&#xD;
&#xD;
        -  Continence status Baseline/6weeks/month Comparing residents&#xD;
&#xD;
      The questionnaire at resident's level is based on the questionnaire &quot;Pflegequalitätserhebung&#xD;
      2.0&quot;, which is the Austrian questionnaire of the &quot;International Prevalence Measurement of&#xD;
      Care Problems&quot; research project. The Institute of Nursing Science at the Medical University&#xD;
      of Graz is member of this research project. Questions concerning the continence status&#xD;
      include the presence, use of catheter, staring point, frequency, diagnosis of urinary&#xD;
      incontinence and the used nursing interventions for the management of urinary incontinence.&#xD;
&#xD;
      The German version of the Care Dependency Scale (CDS) will be used to measure the degree of&#xD;
      care dependency with reference to different needs such as mobility or continence, where lower&#xD;
      scores referred to higher levels of care dependency. The CDS sum score of the residents can&#xD;
      range from completely care dependent (15-24 points), to a great extent care dependent (25-44&#xD;
      points), partially care dependent (45-59 points), to a limited extent care independent (60-69&#xD;
      points) and up to almost care independent (70-75 points).&#xD;
&#xD;
      Outcome measurement Table 2 shows the collected outcome data, the collection time and&#xD;
      purpose. Again the Austrian version of the standardized and tested &quot;International Prevalence&#xD;
      Measurement of Care Problems&quot; will be used to collect data on key outcomes, i.e. UI frequency&#xD;
      and diagnosis.&#xD;
&#xD;
      Table 2: Collected outcome data including time and purpose Collection time Purpose Frequency&#xD;
      of UI Baseline/6 weeks/3 month Intervention effect Diagnosis of UI Baseline/6 weeks/3 month&#xD;
      Intervention effect Use of nursing interventions Baseline/6 weeks/3 month Intervention effect&#xD;
&#xD;
      8.0 Data analysis Data analysis via SPSS (Version 23 or higher) will be performed in&#xD;
      consultation with the Institute for Medical Informatics, Statistics and Documentation of the&#xD;
      Medical University of Graz, Austria, using descriptive statistics and mixed model analyses.&#xD;
      According to Sedgwick (2015) and Shah (2011) the analysis will be conducted following &quot;per&#xD;
      protocol&quot; as well as &quot;intention to treat&quot; analysis. The &quot;per protocol&quot; analysis will show the&#xD;
      effectiveness under study conditions and the &quot;intention to treat&quot; will show the effect of the&#xD;
      nursing recommendations in real life nursing practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 2, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of the frequency of daily urinary incontinence between intervention and control group</measure>
    <time_frame>3 month</time_frame>
    <description>Collected after 3 Month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference of nurses diagnoses for urinary incontinence between intervention and control group</measure>
    <time_frame>3 Month</time_frame>
    <description>Collected after 3 Month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference between the intervention and control group in the use of nursing interventions</measure>
    <time_frame>3 Month</time_frame>
    <description>Collected after 3 Month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine nursing care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evidence based nursing recommendations for the management of urinary incontinence will be introduced.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evidence based nursing recommendations</intervention_name>
    <description>The intervention group gets the evidence based nursing interventions for the conservative management of urinary incontinence in female nursing homes.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. The management of the institution agrees to the random allocation to the&#xD;
             intervention or control group.&#xD;
&#xD;
             2. A clinical guideline including evidence based nursing recommendations related to UI&#xD;
             has not been introduced and implemented.&#xD;
&#xD;
             3. Nursing staff have not received a specialized training in the last 2 years on UI&#xD;
             prevention or management.&#xD;
&#xD;
             4. Less than 5 other major nursing care innovation projects have been implemented&#xD;
             during the last two years.&#xD;
&#xD;
             5. Within the institution there is no specialized nurse employed for the management of&#xD;
             incontinence.&#xD;
&#xD;
        Inclusion criteria for nursing home residents are living in the nursing home at the date of&#xD;
        baseline measurement and being female and assumed to stay for the whole duration of the&#xD;
        study (3 months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manuela Hoedl, BSc, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Nursing Science</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03030144
org study id: 29-007 ex 16/17
nct id: NCT03030144
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The international literature emphasizes the vast benefits of the effective implementation of
      evidence based nursing recommendations in improving patient care processes and enhancing
      health outcomes. The key role of nurses in the prevention, treatment and care of incontinence
      is highlighted. Studies have shown that UI is a neglected nursing care problem in Austria
      e.g. regarding diagnosis and nursing interventions. Nursing recommendations may enhance the
      frequency of diagnosis, the use of nursing interventions as well as decrease the frequency of
      daily UI in nursing home residents. Beside that little is known about nursing recommendations
      implementation regarding urinary incontinence in the nursing home setting, especially in the
      Austrian context.

      The aim of this study is to measure the effectiveness of the implementation of evidence based
      nursing recommendations regarding UI in Austrian nursing homes.
The aim of this study is to measure the effectiveness of the implementation of evidence based
      nursing recommendations regarding UI in Austrian nursing homes, including three research
      questions:

        1. What is the statistical difference between the frequency of daily UI in nursing home
           residents in the intervention group when compared to the control group?

        2. What is the statistical difference between the frequency of documented categorisation of
           UI (UI diagnosis) in the intervention group (implementation of the nursing
           recommendations) compared to the control group (standard care)?

        3. What is the statistical difference between the amounts of used nursing interventions in
           the intervention group compared to the control group?

      5. Methods 5.1. Design A three-month cluster-randomized trial will be conducted in nursing
      homes in Styria and Carinthia.

      5.2. Setting All nursing homes in Styria and Carinthia with a capacity ≥ 50 beds registered
      in a national database [15] will be invited to participate by means of an information flyer
      and email. With regards to practicability invitation will be started with those nursing homes
      with the highest number of beds.

      5.3. Sample Currently there are 176 nursing homes in Styria and Carinthia with a capacity ≥
      50 beds registered in a national database with a total of 15208 nursing home residents.
      Through experiences from former projects a low response rate is expected. We assume a
      response rate of 2% on the nursing home level, amounting to 3 participating nursing homes
      with 259 residents. Nursing homes that want to participate voluntarily will be contacted via
      telephone starting at the largest for further inclusion criteria.

      Inclusion criteria for nursing home residents are living in the nursing home at the date of
      baseline measurement and being female and assumed to stay for the whole duration of the study
      (3 months). Written informed consent from the participating residents or their legal
      representatives is required.

      The nursing interventions are made for women, so we have to focus our sample to women. In
      Austrian nursing homes about 70% are women.Which means we have a total of 181 female nursing
      home residents that can be asked for participation.

      We know from former studies that 90% of nursing home residents are able and willing to
      participate in a research study, amounting to an expected total of 163 participants in the 3
      remaining nursing homes. We assume that 10% of the residents drop out during the study
      period. Therefore 147 female residents in the 3 nursing homes are basis for our calculation.

      These 3 nursing homes will be randomly assigned (eg. via "Randomizer") to the intervention
      group and to the control group.

      An Intra Class Coefficient (ICC) 0.05 was assumed from the literature. With the "Sample Size
      Calculator" developed by Campbell et al. (2004) the detectable difference with these fixed
      sample sizes was calculated.

      With an expected cluster size of 49 nursing home residents in 3 clusters and a power of 80 %
      and a significance level of 0.05 we expect a minimum decrease in the frequency of daily UI
      from 90% to 55%.

      6.0 Ethical considerations This study will be conducted in line with the declaration of
      Helsinki and the "Good scientific practice" of the Medical University of Graz. Nursing homes
      can withdraw their participation without stating reasons via telephone and email. Informed
      consent will be obtained of all participating residents. Residents can withdraw anytime in
      the study without stating reasons.

      The questionnaire is based on the routine nursing care interventions and data regarding UI.
      Therefore no risk or side effects for the participating residents are expected. Nursing homes
      in the control group receive the nursing recommendations after the three month study period.

      In this study only data will be collected. Therefore names of the residents cannot be traced.

      7.0 Data collection including instruments Baseline measurement: The baseline measurement will
      be conducted to gather data on resident level (Table 1).

      Table 1: Collected baseline data including time Collected data Collection time Purpose

        -  Participation Baseline

        -  Age Baseline Comparing residents

        -  Diagnosis Dementia Baseline Comparing residents

        -  Care dependency Baseline/6weeks/month Comparing residents

        -  Continence status Baseline/6weeks/month Comparing residents

      The questionnaire at resident's level is based on the questionnaire "Pflegequalitätserhebung
      2.0", which is the Austrian questionnaire of the "International Prevalence Measurement of
      Care Problems" research project. The Institute of Nursing Science at the Medical University
      of Graz is member of this research project. Questions concerning the continence status
      include the presence, use of catheter, staring point, frequency, diagnosis of urinary
      incontinence and the used nursing interventions for the management of urinary incontinence.

      The German version of the Care Dependency Scale (CDS) will be used to measure the degree of
      care dependency with reference to different needs such as mobility or continence, where lower
      scores referred to higher levels of care dependency. The CDS sum score of the residents can
      range from completely care dependent (15-24 points), to a great extent care dependent (25-44
      points), partially care dependent (45-59 points), to a limited extent care independent (60-69
      points) and up to almost care independent (70-75 points).

      Outcome measurement Table 2 shows the collected outcome data, the collection time and
      purpose. Again the Austrian version of the standardized and tested "International Prevalence
      Measurement of Care Problems" will be used to collect data on key outcomes, i.e. UI frequency
      and diagnosis.

      Table 2: Collected outcome data including time and purpose Collection time Purpose Frequency
      of UI Baseline/6 weeks/3 month Intervention effect Diagnosis of UI Baseline/6 weeks/3 month
      Intervention effect Use of nursing interventions Baseline/6 weeks/3 month Intervention effect

      8.0 Data analysis Data analysis via SPSS (Version 23 or higher) will be performed in
      consultation with the Institute for Medical Informatics, Statistics and Documentation of the
      Medical University of Graz, Austria, using descriptive statistics and mixed model analyses.
      According to Sedgwick (2015) and Shah (2011) the analysis will be conducted following "per
      protocol" as well as "intention to treat" analysis. The "per protocol" analysis will show the
      effectiveness under study conditions and the "intention to treat" will show the effect of the
      nursing recommendations in real life nursing practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference of the frequency of daily urinary incontinence between intervention and control group
time frame: 3 month
description: Collected after 3 Month
measure: Difference of nurses diagnoses for urinary incontinence between intervention and control group
time frame: 3 Month
description: Collected after 3 Month
measure: Difference between the intervention and control group in the use of nursing interventions
time frame: 3 Month
description: Collected after 3 Month
arm group label: Control group
arm group type: No Intervention
description: Routine nursing care
arm group label: Intervention group
arm group type: Other
description: Evidence based nursing recommendations for the management of urinary incontinence will be introduced.
intervention type: Other
intervention name: Evidence based nursing recommendations
description: The intervention group gets the evidence based nursing interventions for the conservative management of urinary incontinence in female nursing homes.
arm group label: Intervention group
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manuela Hoedl, BSc, MSc
role: Principal Investigator
affiliation: Medical University of Graz
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No