<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/NCT01698762</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0172</org_study_id>
    <secondary_id>1R18HS019354-02</secondary_id>
    <secondary_id>NCI-2016-00638</secondary_id>
    <nct_id>NCT01698762</nct_id>
  </id_info>
  <brief_title>IADAPT-Third Phase</brief_title>
  <official_title>IADAPT-Third Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to compare a booklet and a DVD for patients with knee&#xD;
      osteoarthritis, osteoporosis, or rheumatoid arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If you agree to take part in this study, you will be randomly assigned (as in the flip of a&#xD;
      coin) to 1 of 2 study groups:&#xD;
&#xD;
        -  Group 1 will watch a DVD and receive a booklet of information about their disease type&#xD;
           (knee osteoarthritis, osteoporosis, or rheumatoid arthritis).&#xD;
&#xD;
        -  Group 2 will read a booklet about their disease type.&#xD;
&#xD;
      All the materials including the DVD, booklet, and questionnaires will be in English and&#xD;
      Spanish. You may choose which language you prefer to use while watching and/or reading the&#xD;
      materials.&#xD;
&#xD;
      You will be asked to complete questionnaires before and after watching the DVD or reading the&#xD;
      booklet. We will ask you about how the material made you think and feel and how easy or hard&#xD;
      the material was to understand.&#xD;
&#xD;
      You will also fill out short questionnaires that include questions about your demographic&#xD;
      information, your health, your thoughts about bone/joint disease, how you might choose&#xD;
      treatments for bone/joint disease, and how you make treatment decisions. These questionnaires&#xD;
      will take up to 45 minutes to complete in the clinic.&#xD;
&#xD;
      This first visit will take about 60-90 minutes total to complete. If you are unable to&#xD;
      complete this first visit today you will need to complete it within the next two weeks.&#xD;
&#xD;
      You will be asked to fill out these questionnaires again 3 months and 6 months later, by&#xD;
      mail. The study staff will mail you the questionnaires, along with a postage-paid return&#xD;
      envelope that you can use to send the questionnaires back. If you prefer you can also&#xD;
      complete the questionnaires over the phone or the research staff can meet you at the clinic&#xD;
      or your home to complete the questionnaires at 3 and 6 months.&#xD;
&#xD;
      Your participation on this study will be over after you have mailed back the 6-month&#xD;
      questionnaires.&#xD;
&#xD;
      This is an investigational study.&#xD;
&#xD;
      Up to 828 participants will take part in this multicenter study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2013</start_date>
  <completion_date type="Actual">April 21, 2021</completion_date>
  <primary_completion_date type="Actual">April 21, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disease Knowledge and Therapeutic Options</measure>
    <time_frame>3 months</time_frame>
    <description>Primary analyses performed using repeated measures ANOVA, with group allocation - multimedia patient decision aids (MM-PtDA) vs. Comparative Effectiveness Research Summary Guide (CERSG) as the factor of interest and knowledge as the central outcome measure.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">676</enrollment>
  <condition>Musculoskeletal Diseases</condition>
  <arm_group>
    <arm_group_label>Osteoarthritis (OA)</arm_group_label>
    <description>One OA group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type.&#xD;
One OA group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type.&#xD;
Questionnaires completed at baseline, 3, and at 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteoporosis (OP)</arm_group_label>
    <description>One OP group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type.&#xD;
One OP group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type.&#xD;
Questionnaires completed at baseline, 3, and at 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid Arthritis (RA)</arm_group_label>
    <description>One RA group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type.&#xD;
One RA group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type.&#xD;
Questionnaires completed at baseline, 3, and at 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multimedia Patient Decision Aids (MM-PtDAs)</intervention_name>
    <description>Patient group will watch a DVD of information about their disease type.</description>
    <arm_group_label>Osteoarthritis (OA)</arm_group_label>
    <arm_group_label>Osteoporosis (OP)</arm_group_label>
    <arm_group_label>Rheumatoid Arthritis (RA)</arm_group_label>
    <other_name>DVD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparative Effectiveness Research Summary Guide (CERSG)</intervention_name>
    <description>Patient group to read a booklet about their disease type.</description>
    <arm_group_label>Osteoarthritis (OA)</arm_group_label>
    <arm_group_label>Osteoporosis (OP)</arm_group_label>
    <arm_group_label>Rheumatoid Arthritis (RA)</arm_group_label>
    <other_name>Booklet</other_name>
    <other_name>Reading material</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires completed at baseline, 3, and at 6 months.</description>
    <arm_group_label>Osteoarthritis (OA)</arm_group_label>
    <arm_group_label>Osteoporosis (OP)</arm_group_label>
    <arm_group_label>Rheumatoid Arthritis (RA)</arm_group_label>
    <other_name>Surveys</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Harris County Hospital District (HCHD) and Kelsey-Seybold patients in rheumatology,&#xD;
        internal medicine and family practice clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Knee Osteoarthritis (OA): (a) age 45 and over (b) prior diagnosis of knee OA&#xD;
             (unilateral or bilateral) by a physician.&#xD;
&#xD;
          2. Rheumatoid Arthritis (RA): (a) age 18 and over, (b) compliance with American College&#xD;
             of Rheumatology criteria for the diagnosis of RA, (c) and disease duration &lt; or = 10&#xD;
             years&#xD;
&#xD;
          3. Osteoporosis (OP): (a) female gender, (b) age 45 and over, (c) and at least 3 years&#xD;
             post-menopausal&#xD;
&#xD;
          4. Adequate cognitive status as determined by the research assistant (see description in&#xD;
             &quot;Recruitment Eligibility&quot;)&#xD;
&#xD;
          5. Ability to communicate in English or Spanish language without a translator&#xD;
&#xD;
          6. Have access to a telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hospitalized&#xD;
&#xD;
          2. Patients with RA or knee OA who also have any other connective tissue disease or&#xD;
             spondyloarthropathy.&#xD;
&#xD;
          3. Patients with diagnosis of RA and disease duration (&gt;10 years)&#xD;
&#xD;
          4. Patients who do not sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angeles M. Lopez-Olivo, MD, PHD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kelsey-Seybold Clinic</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harris County Hospital District (HCHD)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center</description>
  </link>
  <reference>
    <citation>Lopez-Olivo MA, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Preferred Strategies for Delivering Health Information to Patients With Musculoskeletal Disorders: A Qualitative Study. J Clin Rheumatol. 2022 Jan 1;28(1):e102-e109. doi: 10.1097/RHU.0000000000001627.</citation>
    <PMID>33298811</PMID>
  </reference>
  <reference>
    <citation>Lopez-Olivo MA, Ingleshwar A, Volk RJ, Jibaja-Weiss M, Barbo A, Saag K, Leong A, Suarez-Almazor ME. Development and Pilot Testing of Multimedia Patient Education Tools for Patients With Knee Osteoarthritis, Osteoporosis, and Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Feb;70(2):213-220. doi: 10.1002/acr.23271. Epub 2017 Dec 29.</citation>
    <PMID>28464546</PMID>
  </reference>
  <reference>
    <citation>Lopez-Olivo MA, Lin H, Rizvi T, Barbo Barthel A, Ingleshwar A, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Randomized Controlled Trial of Patient Education Tools for Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Oct;73(10):1470-1478. doi: 10.1002/acr.24362. Epub 2021 Aug 31.</citation>
    <PMID>32583971</PMID>
  </reference>
  <reference>
    <citation>Lopez-Olivo MA, des Bordes JK, Lin H, Volk RJ, Rizvi T, Suarez-Almazor ME. A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis. ACR Open Rheumatol. 2021 Mar;3(3):185-195. doi: 10.1002/acr2.11222. Epub 2021 Feb 16.</citation>
    <PMID>33590950</PMID>
  </reference>
  <reference>
    <citation>Lopez-Olivo MA, des Bordes JKA, Lin H, Rizvi T, Volk RJ, Suarez-Almazor ME. Comparison of multimedia and printed patient education tools for patients with osteoporosis: a 6-month randomized controlled trial. Osteoporos Int. 2020 May;31(5):857-866. doi: 10.1007/s00198-019-05210-4. Epub 2019 Dec 16.</citation>
    <PMID>31844906</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>May 24, 2021</last_update_submitted>
  <last_update_submitted_qc>May 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Musculoskeletal Diseases</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>OA</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>RA</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>OP</keyword>
  <keyword>Multimedia Patient Decision Aids</keyword>
  <keyword>MM-PtDAs</keyword>
  <keyword>DVD</keyword>
  <keyword>Comparative Effectiveness Research Summary Guide</keyword>
  <keyword>CERSG</keyword>
  <keyword>Booklet</keyword>
  <keyword>Questionnaires</keyword>
  <keyword>Surveys</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01698762
org study id: 2012-0172
secondary id: 1R18HS019354-02
secondary id: NCI-2016-00638
nct id: NCT01698762
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
The goal of this research study is to compare a booklet and a DVD for patients with knee
      osteoarthritis, osteoporosis, or rheumatoid arthritis.
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
      coin) to 1 of 2 study groups:

        -  Group 1 will watch a DVD and receive a booklet of information about their disease type
           (knee osteoarthritis, osteoporosis, or rheumatoid arthritis).

        -  Group 2 will read a booklet about their disease type.

      All the materials including the DVD, booklet, and questionnaires will be in English and
      Spanish. You may choose which language you prefer to use while watching and/or reading the
      materials.

      You will be asked to complete questionnaires before and after watching the DVD or reading the
      booklet. We will ask you about how the material made you think and feel and how easy or hard
      the material was to understand.

      You will also fill out short questionnaires that include questions about your demographic
      information, your health, your thoughts about bone/joint disease, how you might choose
      treatments for bone/joint disease, and how you make treatment decisions. These questionnaires
      will take up to 45 minutes to complete in the clinic.

      This first visit will take about 60-90 minutes total to complete. If you are unable to
      complete this first visit today you will need to complete it within the next two weeks.

      You will be asked to fill out these questionnaires again 3 months and 6 months later, by
      mail. The study staff will mail you the questionnaires, along with a postage-paid return
      envelope that you can use to send the questionnaires back. If you prefer you can also
      complete the questionnaires over the phone or the research staff can meet you at the clinic
      or your home to complete the questionnaires at 3 and 6 months.

      Your participation on this study will be over after you have mailed back the 6-month
      questionnaires.

      This is an investigational study.

      Up to 828 participants will take part in this multicenter study.
observational model: Case-Control
time perspective: Prospective
measure: Disease Knowledge and Therapeutic Options
time frame: 3 months
description: Primary analyses performed using repeated measures ANOVA, with group allocation - multimedia patient decision aids (MM-PtDA) vs. Comparative Effectiveness Research Summary Guide (CERSG) as the factor of interest and knowledge as the central outcome measure.
arm group label: Osteoarthritis (OA)
description: One OA group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type.
One OA group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type.
Questionnaires completed at baseline, 3, and at 6 months.
arm group label: Osteoporosis (OP)
description: One OP group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type.
One OP group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type.
Questionnaires completed at baseline, 3, and at 6 months.
arm group label: Rheumatoid Arthritis (RA)
description: One RA group will watch a DVD - Multimedia Patient Decision Aids (MM-PtDAs) of information about their disease type.
One RA group will read a booklet - Comparative Effectiveness Research Summary Guide (CERSG) about their disease type.
Questionnaires completed at baseline, 3, and at 6 months.
intervention type: Other
intervention name: Multimedia Patient Decision Aids (MM-PtDAs)
description: Patient group will watch a DVD of information about their disease type.
arm group label: Osteoarthritis (OA)
arm group label: Osteoporosis (OP)
arm group label: Rheumatoid Arthritis (RA)
other name: DVD
intervention type: Other
intervention name: Comparative Effectiveness Research Summary Guide (CERSG)
description: Patient group to read a booklet about their disease type.
arm group label: Osteoarthritis (OA)
arm group label: Osteoporosis (OP)
arm group label: Rheumatoid Arthritis (RA)
other name: Booklet
other name: Reading material
intervention type: Behavioral
intervention name: Questionnaires
description: Questionnaires completed at baseline, 3, and at 6 months.
arm group label: Osteoarthritis (OA)
arm group label: Osteoporosis (OP)
arm group label: Rheumatoid Arthritis (RA)
other name: Surveys
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Angeles M. Lopez-Olivo, MD, PHD, MS
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
facility: 
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center
citation: Lopez-Olivo MA, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Preferred Strategies for Delivering Health Information to Patients With Musculoskeletal Disorders: A Qualitative Study. J Clin Rheumatol. 2022 Jan 1;28(1):e102-e109. doi: 10.1097/RHU.0000000000001627.
PMID: 33298811
citation: Lopez-Olivo MA, Ingleshwar A, Volk RJ, Jibaja-Weiss M, Barbo A, Saag K, Leong A, Suarez-Almazor ME. Development and Pilot Testing of Multimedia Patient Education Tools for Patients With Knee Osteoarthritis, Osteoporosis, and Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Feb;70(2):213-220. doi: 10.1002/acr.23271. Epub 2017 Dec 29.
PMID: 28464546
citation: Lopez-Olivo MA, Lin H, Rizvi T, Barbo Barthel A, Ingleshwar A, des Bordes JKA, Jibaja-Weiss M, Volk RJ, Suarez-Almazor ME. Randomized Controlled Trial of Patient Education Tools for Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021 Oct;73(10):1470-1478. doi: 10.1002/acr.24362. Epub 2021 Aug 31.
PMID: 32583971
citation: Lopez-Olivo MA, des Bordes JK, Lin H, Volk RJ, Rizvi T, Suarez-Almazor ME. A Randomized Controlled Trial Comparing Two Self-Administered Educational Strategies for Patients With Knee Osteoarthritis. ACR Open Rheumatol. 2021 Mar;3(3):185-195. doi: 10.1002/acr2.11222. Epub 2021 Feb 16.
PMID: 33590950
citation: Lopez-Olivo MA, des Bordes JKA, Lin H, Rizvi T, Volk RJ, Suarez-Almazor ME. Comparison of multimedia and printed patient education tools for patients with osteoporosis: a 6-month randomized controlled trial. Osteoporos Int. 2020 May;31(5):857-866. doi: 10.1007/s00198-019-05210-4. Epub 2019 Dec 16.
PMID: 31844906
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases