<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/NCT02224300</url>
  </required_header>
  <id_info>
    <org_study_id>LAPHOI</org_study_id>
    <nct_id>NCT02224300</nct_id>
  </id_info>
  <brief_title>Nursing Care With Patients With Venous Leg Ulcers</brief_title>
  <official_title>Nursing Care With Patients With Venous Leg Ulcers - Developing an Internet-based Education Program and Evaluation of Its Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims are:&#xD;
&#xD;
        -  develop an Internet-based education programme about venous leg ulcer nursing care (ELC)&#xD;
&#xD;
        -  evaluate the clinical, cognitive and economical outcomes of education programme&#xD;
&#xD;
      Research questions are:&#xD;
&#xD;
      1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg&#xD;
      ulcer nursing care, theoretical knowledge level and practical knowledge)?&#xD;
&#xD;
      Hypotheses for research question 1 are:&#xD;
&#xD;
        1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical&#xD;
           knowledge) than those who will not use the ELC.&#xD;
&#xD;
        2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing&#xD;
           care than those who will not use the ELC.&#xD;
&#xD;
      2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?&#xD;
&#xD;
      Hypotheses for research question 2 are:&#xD;
&#xD;
        1. Ulcer healing progresses better among patients who are taken care by nurses using the&#xD;
           ELC.&#xD;
&#xD;
        2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.&#xD;
&#xD;
        3. Nurses using the ELC will use mire adequate treatment supplies than those who will not&#xD;
           use the ELC.&#xD;
&#xD;
      3. What are the economical outcomes (treatment time and supply usage) of ELC?&#xD;
&#xD;
      Hypothesis for research question 3 is:&#xD;
&#xD;
      1. The economical expenditures will be lower among nurses using the ELC.&#xD;
&#xD;
      The ultimate aim is to promote evidence-based nursing care among patients with venous leg&#xD;
      ulcer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study takes place in home-care in two Finnish municipality, which are similar size and&#xD;
      staff structure and working ideology are basically the same.&#xD;
&#xD;
      Enrolment of participants has started with information occasion in both municipalities in&#xD;
      June 2014. Nurses were asked to fill the Patients Clinical Situation Questionnaire, handouts&#xD;
      and forms for informed consent were delivered. (Figure 1) All eligible nurses and patients&#xD;
      will be identified with Patient Clinical Assessment. The sample size was determined with&#xD;
      power analysis and the result was that 200 nurses are needed in the intervention group and&#xD;
      100 nurses in the comparison group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">October 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in nurses´ knowledge before and after the education</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Knowledge is divided into nurses´ perceived knowledge, practical and theoretical knowledge.&#xD;
Changes in perceived knowledge will be measured with structured self-completed questionnaire.&#xD;
Changes in practical knowledge will be measured with structured observation. Changes in theoretical knowledge will be measured with structured questionnaire (knowledge-test).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Changes in attitudes will be measured with structured questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinical variables; venous leg ulcer size.</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Changes in venous leg sizes variables will be measured during observations. Each venous leg ulcer will measured with paper ruler.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinical variables; adequacy of the supplies used.</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Changes in adequacy of supplies used will be measured with structured observation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in economical variables cost of supplies and treatment time.</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Changes in economical variables will be measured with structured observation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>- Venous Leg Ulcers</condition>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group will receive the ELC for six weeks (15.9. - 26.10.2014) and comparison group will not receive it.&#xD;
Members of the intervention group in will work in teams of 10 nurses with weekly questions (released in Mondays) based on patient-description existing in Moodle. One member of the team will send the solutions to questions once a week (in Thursdays) Moodle. Researcher will download the model-answer to Moodle once a week (in Fridays) and nurses will compare their answer to model answer (self-evaluation).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based education of venous leg ulcer nursing care</intervention_name>
    <description>Intervention is delivering the ELC (Electronic Learning of venous leg ulcer nursing care) to home health-care nurses (registered nurses, public health nurses and licensed practical nurses) . The ELC development was based on the integrative literature review about nurses' knowledge gaps on venous leg ulcer nursing care. The pedagogical basis of the ELC is constructivism and blended learning approach. The ELC comprises contact learning and distance learning. Content of ELC is evidence-based information already existing in Internet and the basis of the information is the Finnish Current Care Guidelines for Chronic leg ulcers (2014), which are evidence-based clinical practice guidelines. They are intended as basis for ulcer treatment decisions, and guidelines can be used by nurses and other healthcare professionals.</description>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for nurses:&#xD;
&#xD;
          1. Working in municipality home-care&#xD;
&#xD;
          2. Permanent attachment or three months or longer temporary post in municipality&#xD;
             home-care&#xD;
&#xD;
          3. Working in home-care area where patients with chronic leg ulcer are taken care during&#xD;
             the study&#xD;
&#xD;
        Exclusion criteria for nurses:&#xD;
&#xD;
        1. Working in other place than home-care There are no other exclusion criteria.&#xD;
&#xD;
        Inclusion criteria for patients to observation are:&#xD;
&#xD;
          1. Home health-care patient aged 60 or over&#xD;
&#xD;
          2. Venous leg ulcer diagnosis&#xD;
&#xD;
          3. Chronic ulcer in the lower leg without diagnosis&#xD;
&#xD;
        Exclusion criteria for patients:&#xD;
&#xD;
        1. An ulcer with other diagnosis than venous leg ulcer diagnosis There are no other&#xD;
        exclusion criteria for patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Minna S Ylönen, PhD-candidate</last_name>
    <phone>+358400667809</phone>
    <email>misuyl@utu.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Minna Ylönen, PhD-candidate</last_name>
    <phone>+358400667809</phone>
    <email>misuyl@utu.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Homecare</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johanna Ritvanen, MNSc</last_name>
      <email>johanna.ritvanen@turku.fi</email>
    </contact>
    <investigator>
      <last_name>Minna Ylönen, PhD (c)</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>August 22, 2014</last_update_submitted>
  <last_update_submitted_qc>August 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Minna Ylönen</investigator_full_name>
    <investigator_title>PhD candidate</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 10, 2016</submitted>
    <returned>June 16, 2016</returned>
  </pending_results>
  <!-- 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/NCT02224300
org study id: LAPHOI
nct id: NCT02224300
lead sponsor: 
has dmc: Yes
Aims are:

        -  develop an Internet-based education programme about venous leg ulcer nursing care (ELC)

        -  evaluate the clinical, cognitive and economical outcomes of education programme

      Research questions are:

      1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg
      ulcer nursing care, theoretical knowledge level and practical knowledge)?

      Hypotheses for research question 1 are:

        1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical
           knowledge) than those who will not use the ELC.

        2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing
           care than those who will not use the ELC.

      2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?

      Hypotheses for research question 2 are:

        1. Ulcer healing progresses better among patients who are taken care by nurses using the
           ELC.

        2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.

        3. Nurses using the ELC will use mire adequate treatment supplies than those who will not
           use the ELC.

      3. What are the economical outcomes (treatment time and supply usage) of ELC?

      Hypothesis for research question 3 is:

      1. The economical expenditures will be lower among nurses using the ELC.

      The ultimate aim is to promote evidence-based nursing care among patients with venous leg
      ulcer.
The study takes place in home-care in two Finnish municipality, which are similar size and
      staff structure and working ideology are basically the same.

      Enrolment of participants has started with information occasion in both municipalities in
      June 2014. Nurses were asked to fill the Patients Clinical Situation Questionnaire, handouts
      and forms for informed consent were delivered. (Figure 1) All eligible nurses and patients
      will be identified with Patient Clinical Assessment. The sample size was determined with
      power analysis and the result was that 200 nurses are needed in the intervention group and
      100 nurses in the comparison group.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Changes in nurses´ knowledge before and after the education
time frame: Baseline, Week 8 and Week 12
description: Knowledge is divided into nurses´ perceived knowledge, practical and theoretical knowledge.
Changes in perceived knowledge will be measured with structured self-completed questionnaire.
Changes in practical knowledge will be measured with structured observation. Changes in theoretical knowledge will be measured with structured questionnaire (knowledge-test).
measure: Changes in nurses´ attitudes towards patients with venous leg ulcers before and after the education
time frame: Baseline, Week 8 and Week 12
description: Changes in attitudes will be measured with structured questionnaire.
measure: Changes in clinical variables; venous leg ulcer size.
time frame: Baseline, Week 8 and Week 12
description: Changes in venous leg sizes variables will be measured during observations. Each venous leg ulcer will measured with paper ruler.
measure: Changes in clinical variables; adequacy of the supplies used.
time frame: Baseline, Week 8 and Week 12
description: Changes in adequacy of supplies used will be measured with structured observation.
measure: Changes in economical variables cost of supplies and treatment time.
time frame: Baseline, Week 8 and Week 12
description: Changes in economical variables will be measured with structured observation.
arm group label: Education
arm group type: Experimental
description: Intervention group will receive the ELC for six weeks (15.9. - 26.10.2014) and comparison group will not receive it.
Members of the intervention group in will work in teams of 10 nurses with weekly questions (released in Mondays) based on patient-description existing in Moodle. One member of the team will send the solutions to questions once a week (in Thursdays) Moodle. Researcher will download the model-answer to Moodle once a week (in Fridays) and nurses will compare their answer to model answer (self-evaluation).
intervention type: Behavioral
intervention name: Internet-based education of venous leg ulcer nursing care
description: Intervention is delivering the ELC (Electronic Learning of venous leg ulcer nursing care) to home health-care nurses (registered nurses, public health nurses and licensed practical nurses) . The ELC development was based on the integrative literature review about nurses' knowledge gaps on venous leg ulcer nursing care. The pedagogical basis of the ELC is constructivism and blended learning approach. The ELC comprises contact learning and distance learning. Content of ELC is evidence-based information already existing in Internet and the basis of the information is the Finnish Current Care Guidelines for Chronic leg ulcers (2014), which are evidence-based clinical practice guidelines. They are intended as basis for ulcer treatment decisions, and guidelines can be used by nurses and other healthcare professionals.
arm group label: Education
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Minna S Ylönen, PhD-candidate
phone: +358400667809
email: misuyl@utu.fi
last name: Minna Ylönen, PhD-candidate
phone: +358400667809
email: misuyl@utu.fi
facility: 
status: Recruiting
contact: 
investigator: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Minna Ylönen
investigator title: PhD candidate
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Ulcer
submitted: May 10, 2016
returned: June 16, 2016