<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/NCT03254771</url>
  </required_header>
  <id_info>
    <org_study_id>PI15-01264</org_study_id>
    <nct_id>NCT03254771</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Decision Aid for Knee Osteoarthritis</brief_title>
  <official_title>Effectiveness of a Decision Aid for Patients With Knee Osteoarthritis Candidates for Primary Total Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Servicio Canario de Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Basurto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Donostia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Servicio Canario de Salud</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 main goal of this study is assess the effectiveness of a DA for patients with knee&#xD;
      osteoarthritis candidates to ART&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of knee total arthroplasty (ART) interventions has increased in the last 10 years&#xD;
      in European countries, partly due to the aging of the population and partly because of the&#xD;
      increase in the use of these interventions to improve the quality of life among elderly&#xD;
      patients. According to the Organization for Economic Cooperation and Development (OECD) 2012,&#xD;
      from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years. .&#xD;
&#xD;
      The role of citizens in decisions affecting their health is changing. Individual factors such&#xD;
      as improving educational attainment and access to medical information, and collective factors&#xD;
      such as training of patient groups and changes in legislation (informed consent, autonomy&#xD;
      principle) have motivated the transition from a paternalistic model to a co-responsibility&#xD;
      model. Shared decision-making (TDC) has been proposed in recent years as a model of care that&#xD;
      promotes users' involvement in the decisions about their treatment, in those situations where&#xD;
      there is uncertainty and / or the scientific evidence reports a balance between benefits and&#xD;
      risks that is similar for two or more therapeutic options. Decision aids (DA) are tools&#xD;
      designed to promote and facilitate patients' involvement in medical decisions concerning&#xD;
      their health&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Randomized controlled trial to evaluate the effectiveness of the DA versus usual care in&#xD;
      reducing decisional conflict, increasing knowledge of the disease/treatments, informed choice&#xD;
      and the satisfaction with the decision making process, and decreasing decisional regret.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Decisional conflict, measured by the Decisional Conflict Scale (DCS).</measure>
    <time_frame>Immediately after the intervention; 6 months after the intervention (only non-operated patients)</time_frame>
    <description>The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of the disease and treatments</measure>
    <time_frame>Immediately after the intervention; 6 months after the intervention (only non-operated patients)</time_frame>
    <description>A 7-item scale will be udes to assess patients' knowledge of the disease and treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goals and concerns</measure>
    <time_frame>Immediately after the intervention; 6 months after the intervention (only non-operated patients)</time_frame>
    <description>A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment preference</measure>
    <time_frame>Immediately after the intervention; 6 months (only non-operated patients)</time_frame>
    <description>Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the decision making process</measure>
    <time_frame>Immediately after the intervention; 6 months</time_frame>
    <description>The scale developed by Barry et al. (1997) will be used, composed of 12 items measuring patients' satisfaction with information and care provided</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional regret, measured by the Decisional Regret Scale (DRS)</measure>
    <time_frame>6 months (only operated patients)</time_frame>
    <description>The DRS contains five items measuring patients regret with the treatment decision</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">193</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group, the usual explanation about the disease and the possibilities of treatment will be followed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the Intervention group, the Decision Aid (DA) will be presented and explained to the patient by research personnel at a schedule previously agreed with the patient. The patient will be given a paper copy of the (DA) to take home, as well as a web link to the computer application, and oral and written instructions to review the material again and perform value clarification exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision aid</intervention_name>
    <description>Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with osteoarthritis of the knee&#xD;
&#xD;
          -  Candidates for arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already undergone knee arthroplasty&#xD;
&#xD;
          -  Patients younger than 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amado Rivero Santana, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Researcher</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Evaluación de. Servicio Canario de Salud -</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <zip>38004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>June 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>January 20, 2020</last_update_submitted>
  <last_update_submitted_qc>January 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee ostheoartritis</keyword>
  <keyword>Arthroplasty</keyword>
  <keyword>Clinical trial</keyword>
  <keyword>Decision aids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03254771
org study id: PI15-01264
nct id: NCT03254771
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main goal of this study is assess the effectiveness of a DA for patients with knee
      osteoarthritis candidates to ART
The number of knee total arthroplasty (ART) interventions has increased in the last 10 years
      in European countries, partly due to the aging of the population and partly because of the
      increase in the use of these interventions to improve the quality of life among elderly
      patients. According to the Organization for Economic Cooperation and Development (OECD) 2012,
      from 2000 to 2010 in Spain the percentage of knee ART has doubled in recent years. .

      The role of citizens in decisions affecting their health is changing. Individual factors such
      as improving educational attainment and access to medical information, and collective factors
      such as training of patient groups and changes in legislation (informed consent, autonomy
      principle) have motivated the transition from a paternalistic model to a co-responsibility
      model. Shared decision-making (TDC) has been proposed in recent years as a model of care that
      promotes users' involvement in the decisions about their treatment, in those situations where
      there is uncertainty and / or the scientific evidence reports a balance between benefits and
      risks that is similar for two or more therapeutic options. Decision aids (DA) are tools
      designed to promote and facilitate patients' involvement in medical decisions concerning
      their health

      Objectives:

      To assess the effectiveness of a DA for patients with knee osteoarthritis candidates to ART

      Methodology:

      Randomized controlled trial to evaluate the effectiveness of the DA versus usual care in
      reducing decisional conflict, increasing knowledge of the disease/treatments, informed choice
      and the satisfaction with the decision making process, and decreasing decisional regret.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
masking description: Open label
measure: Decisional conflict, measured by the Decisional Conflict Scale (DCS).
time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
description: The DCS measures patients' uncertainty about treatment choice. It is composed of five subscales: uninformed, values, support, uncertainty and effectiveness
measure: Knowledge of the disease and treatments
time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
description: A 7-item scale will be udes to assess patients' knowledge of the disease and treatments
measure: Goals and concerns
time frame: Immediately after the intervention; 6 months after the intervention (only non-operated patients)
description: A 10-item scale will assess the importance that patients attribute to different characteristics of avaliable treatments
measure: Treatment preference
time frame: Immediately after the intervention; 6 months (only non-operated patients)
description: Patients will be asked the treatment they prefer: AINEs, knee injections or arthroplasty
measure: Satisfaction with the decision making process
time frame: Immediately after the intervention; 6 months
description: The scale developed by Barry et al. (1997) will be used, composed of 12 items measuring patients' satisfaction with information and care provided
measure: Decisional regret, measured by the Decisional Regret Scale (DRS)
time frame: 6 months (only operated patients)
description: The DRS contains five items measuring patients regret with the treatment decision
arm group label: Control group
arm group type: No Intervention
description: In the control group, the usual explanation about the disease and the possibilities of treatment will be followed
arm group label: Intervention group
arm group type: Experimental
description: In the Intervention group, the Decision Aid (DA) will be presented and explained to the patient by research personnel at a schedule previously agreed with the patient. The patient will be given a paper copy of the (DA) to take home, as well as a web link to the computer application, and oral and written instructions to review the material again and perform value clarification exercises.
intervention type: Other
intervention name: Decision aid
description: Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Amado Rivero Santana, PhD
role: Study Chair
affiliation: Researcher
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No