<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/NCT03241693</url>
  </required_header>
  <id_info>
    <org_study_id>45/FO/18/2010</org_study_id>
    <nct_id>NCT03241693</nct_id>
  </id_info>
  <brief_title>Blended-learning in Physiotherapy: Professional Ethics</brief_title>
  <official_title>Effect of a Blended-learning Programme on Physiotherapy Students´ Attitude, Knowledge and Opinions Towards Learning Professional Ethics.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to assess the effect of a blended-learning model on physiotherapy&#xD;
      students´ attitude, knowledge and opinions towards learning professional ethics.&#xD;
&#xD;
      A simple-blind clinical trial was performed. An eight-month blended learning program to teach&#xD;
      professional ethics in clinical practices was worked out. An online syllabus and online&#xD;
      activities were elaborated, whilst face to face active participation techniques were&#xD;
      performed to discuss ethical issues detected among practices. Students´ attitudes, knowledge&#xD;
      and opinions towards learning professional ethics were assessed. Non-parametric tests were&#xD;
      carried out. All the participants were informed about the study and procedures, and provided&#xD;
      written informed consent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants. 139 third-year degree students of Physiotherapy Degree at the University, aged&#xD;
      between 20 and 30 years, were recruited voluntarily from September 2010 to July 2011. All&#xD;
      enrolled participants were informed of the purpose of the study and procedures, and provided&#xD;
      written informed consent. The study was carried out at the institution where the authors&#xD;
      belong.&#xD;
&#xD;
      Research design. A prospective simple-blind trial was performed. After baseline assessment,&#xD;
      participants were allocated to one of the two groups (control group, n=65; experimental&#xD;
      group, n=64). An external assistant not involved in the study performed assignment.&#xD;
&#xD;
      Intervention. A Physiotherapy professor with over-10-year experience in Ethics and&#xD;
      Physiotherapy performed the teaching methodology. She opened the allocation envelopes and&#xD;
      applied the teaching methodology to the EG according to the group assignment. The&#xD;
      intervention consisted of an eight-month blended-learning program based in professional&#xD;
      ethics, including two phases: A) online syllabus and online activities (4 months); and B)&#xD;
      face to face group sessions (4 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2010</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">February 2011</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attitude towards learning professional ethics</measure>
    <time_frame>8 months</time_frame>
    <description>Attitude towards learning professional ethics was measured. A self-reported questionnaire of 33 items (the &quot;Attitudes Questionnaire towards Professional Ethics in Physiotherapy&quot;, AQPEPT) was previously described by Aguilar-Rodríguez et al. A high reliability (Cronbach's alpha=0.898) was obtained. All items of the AQPEPT approached to the one-dimensionality needed in cases where attitudes are analyzed.The higher score indicated the best attitude.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge towards learning professional ethics</measure>
    <time_frame>4 months, 8 months</time_frame>
    <description>Knowledge towards learning professional ethics was assessed. A self-reported questionnaire of 19 items (the &quot;Perceptions about Knowledge regarding Professional Ethics in Physiotherapy&quot;, PKPEP , Cronbach's alpha=0,760) was previously described by Marques-Sule et al. The higher score indicated the best knowledge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opinions about the blended-learning programme.</measure>
    <time_frame>4 months, 8 months</time_frame>
    <description>Students´ opinions about the blended-learning programme were measured. Opinions about the online learning were assessed by a questionnaire comprised of eight dichotomous questions and one open question. The eight dichotomous questions aimed at evaluating if the syllabus, activities and communication system (Virtual Classroom) were considered as useful tools or not. No central options were provided to induce students to choose a positive or negative answer. Moreover, the open question aimed at adding any personal comment about the methodology. Secondly, opinions about the methodology used in the face-to-face group sessions were assessed by a questionnaire comprised of five items and one open question. Several questions about the blended-learning program were proposed: methodology of the face-to-face learning (2 items), methodology used along the study (3 items), and an open question about how to improve the teaching of professional ethics.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Ethics</condition>
  <condition>Attitude</condition>
  <condition>Knowledge</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Physiotherapy students</description>
  </arm_group>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physiotherapy students</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blended-learning in ethics</intervention_name>
    <description>Experimental group followed clinical practices in hospital centers during 8 months.&#xD;
In addition, an online specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six online related activities were created: to solve situations related to real clinical practices. Six face to face group sessions based on cooperative learning were planned in order to discuss ethical issues detected among clinical practices during 4 months. Students were divided in small groups, 4-5 participants each, and active participation techniques were used.</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>Control group followed clinical practices in hospital centers during 8 months as usual.&#xD;
In the control group, case study method was also used, thus students in control group had to create and perform a public exposition of a real clinical case about professional ethics. Cases had to be related to clinical practices in order to recognize ethical situations in the work environment. Neither online learning nor online activities were carried out.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To study the physical therapy degree at the University of Valencia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criterion was having prior training on Ethics subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Elena Marques-Sule</investigator_full_name>
    <investigator_title>Doctor in Physiotherapy</investigator_title>
  </responsible_party>
  <!-- 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/NCT03241693
org study id: 45/FO/18/2010
nct id: NCT03241693
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess the effect of a blended-learning model on physiotherapy
      students´ attitude, knowledge and opinions towards learning professional ethics.

      A simple-blind clinical trial was performed. An eight-month blended learning program to teach
      professional ethics in clinical practices was worked out. An online syllabus and online
      activities were elaborated, whilst face to face active participation techniques were
      performed to discuss ethical issues detected among practices. Students´ attitudes, knowledge
      and opinions towards learning professional ethics were assessed. Non-parametric tests were
      carried out. All the participants were informed about the study and procedures, and provided
      written informed consent.
Participants. 139 third-year degree students of Physiotherapy Degree at the University, aged
      between 20 and 30 years, were recruited voluntarily from September 2010 to July 2011. All
      enrolled participants were informed of the purpose of the study and procedures, and provided
      written informed consent. The study was carried out at the institution where the authors
      belong.

      Research design. A prospective simple-blind trial was performed. After baseline assessment,
      participants were allocated to one of the two groups (control group, n=65; experimental
      group, n=64). An external assistant not involved in the study performed assignment.

      Intervention. A Physiotherapy professor with over-10-year experience in Ethics and
      Physiotherapy performed the teaching methodology. She opened the allocation envelopes and
      applied the teaching methodology to the EG according to the group assignment. The
      intervention consisted of an eight-month blended-learning program based in professional
      ethics, including two phases: A) online syllabus and online activities (4 months); and B)
      face to face group sessions (4 months).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Attitude towards learning professional ethics
time frame: 8 months
description: Attitude towards learning professional ethics was measured. A self-reported questionnaire of 33 items (the "Attitudes Questionnaire towards Professional Ethics in Physiotherapy", AQPEPT) was previously described by Aguilar-Rodríguez et al. A high reliability (Cronbach's alpha=0.898) was obtained. All items of the AQPEPT approached to the one-dimensionality needed in cases where attitudes are analyzed.The higher score indicated the best attitude.
measure: Knowledge towards learning professional ethics
time frame: 4 months, 8 months
description: Knowledge towards learning professional ethics was assessed. A self-reported questionnaire of 19 items (the "Perceptions about Knowledge regarding Professional Ethics in Physiotherapy", PKPEP , Cronbach's alpha=0,760) was previously described by Marques-Sule et al. The higher score indicated the best knowledge.
measure: Opinions about the blended-learning programme.
time frame: 4 months, 8 months
description: Students´ opinions about the blended-learning programme were measured. Opinions about the online learning were assessed by a questionnaire comprised of eight dichotomous questions and one open question. The eight dichotomous questions aimed at evaluating if the syllabus, activities and communication system (Virtual Classroom) were considered as useful tools or not. No central options were provided to induce students to choose a positive or negative answer. Moreover, the open question aimed at adding any personal comment about the methodology. Secondly, opinions about the methodology used in the face-to-face group sessions were assessed by a questionnaire comprised of five items and one open question. Several questions about the blended-learning program were proposed: methodology of the face-to-face learning (2 items), methodology used along the study (3 items), and an open question about how to improve the teaching of professional ethics.
arm group label: control group
arm group type: Other
description: Physiotherapy students
arm group label: experimental group
arm group type: Experimental
description: Physiotherapy students
intervention type: Other
intervention name: blended-learning in ethics
description: Experimental group followed clinical practices in hospital centers during 8 months.
In addition, an online specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six online related activities were created: to solve situations related to real clinical practices. Six face to face group sessions based on cooperative learning were planned in order to discuss ethical issues detected among clinical practices during 4 months. Students were divided in small groups, 4-5 participants each, and active participation techniques were used.
arm group label: experimental group
intervention type: Other
intervention name: control group
description: Control group followed clinical practices in hospital centers during 8 months as usual.
In the control group, case study method was also used, thus students in control group had to create and perform a public exposition of a real clinical case about professional ethics. Cases had to be related to clinical practices in order to recognize ethical situations in the work environment. Neither online learning nor online activities were carried out.
arm group label: control group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Elena Marques-Sule
investigator title: Doctor in Physiotherapy