<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/NCT01678300</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-000100</org_study_id>
    <nct_id>NCT01678300</nct_id>
  </id_info>
  <brief_title>Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)</brief_title>
  <official_title>Qualitative Study of Topical Mesalamine Adherence in Patients With Ulcerative Colitis(UC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this protocol is:&#xD;
&#xD;
        1. To quantify the prevalence of adherence to topical mesalamine in patients with UC&#xD;
&#xD;
        2. To describe the determinants of medication adherence in patients with UC prescribed&#xD;
           topical mesalamine&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to&#xD;
      topical mesalamine adherence exist in patients with UC. These factors can be identified using&#xD;
      qualitative testing in order to develop and design appropriate behavioral interventions to&#xD;
      reduce non-adherence.&#xD;
&#xD;
      The investigators will undertake an observational study of medication persistence in 100&#xD;
      patients in the BIDMC clinic, &quot;Persistence Cohort&quot;. Persistence will be measured using&#xD;
      12-month pharmacy refill data. The investigators will also employ a qualitative research&#xD;
      design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10&#xD;
      patients and Phase II - Focus Groups (2) with 5 patients each.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of &quot;non-persistence&quot; amongst patients prescribed topical mesalamine for UC</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome (remission / relapse) at 12 months grouped by persistence status</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence phenotype details</measure>
    <time_frame>12 months</time_frame>
    <description>Prevalence of self-reported &quot;low adherence&quot; amongst patients prescribed topical mesalamine&#xD;
Demographic and disease phenotype variables associated with &quot;non persistence&quot; or &quot;low adherence&quot; using multivariate logistic regression analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality-of-life score at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Short Inflammatory Bowel Disease Questionnaire score at 12 months</description>
  </secondary_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Ulcerative Colitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The population of this study will be adults with diagnosed Ulcerative Colitis who have been&#xD;
        prescribed topical mesalamine (Rowasa/Canasa) for treatment of their ulcerative colitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must have ulcerative colitis diagnosed by a doctor at least 1 month prior to study&#xD;
             participation&#xD;
&#xD;
          -  must be prescribed topical mesalamine (e.g. Rowasa enemas or Canasa suppositories) by&#xD;
             a doctor&#xD;
&#xD;
          -  must be receiving care at Beth Israel Deaconess Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no diagnosis of ulcerative colitis&#xD;
&#xD;
          -  no prescription for topical mesalamine&#xD;
&#xD;
          -  not receiving care at Beth Israel Deaconess Medical Center&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan C Moss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>November 13, 2015</last_update_submitted>
  <last_update_submitted_qc>November 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Alan C. Moss</investigator_full_name>
    <investigator_title>Director of Translational Research, Inflammatory Bowel Disease Center</investigator_title>
  </responsible_party>
  <keyword>Ulcerative Colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</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/NCT01678300
org study id: 2012-P-000100
nct id: NCT01678300
lead sponsor: 
has dmc: No
The purpose of this protocol is:

        1. To quantify the prevalence of adherence to topical mesalamine in patients with UC

        2. To describe the determinants of medication adherence in patients with UC prescribed
           topical mesalamine
Patient adherence with topical mesalamine is low. Behavioral and psycho-social barriers to
      topical mesalamine adherence exist in patients with UC. These factors can be identified using
      qualitative testing in order to develop and design appropriate behavioral interventions to
      reduce non-adherence.

      The investigators will undertake an observational study of medication persistence in 100
      patients in the BIDMC clinic, "Persistence Cohort". Persistence will be measured using
      12-month pharmacy refill data. The investigators will also employ a qualitative research
      design with discrete choice modeling in two phases: Phase I - Initial Interviews with 10
      patients and Phase II - Focus Groups (2) with 5 patients each.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of "non-persistence" amongst patients prescribed topical mesalamine for UC
time frame: 12 months
measure: Clinical outcome (remission / relapse) at 12 months grouped by persistence status
time frame: 12 months
description: Clinical outcome (remission / relapse) based on Simple Colitis Activity Index Score
measure: Adherence phenotype details
time frame: 12 months
description: Prevalence of self-reported "low adherence" amongst patients prescribed topical mesalamine
Demographic and disease phenotype variables associated with "non persistence" or "low adherence" using multivariate logistic regression analysis
measure: Quality-of-life score at 12 months
time frame: 12 months
description: Short Inflammatory Bowel Disease Questionnaire score at 12 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alan C Moss, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Alan C. Moss
investigator title: Director of Translational Research, Inflammatory Bowel Disease Center
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer