<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/NCT03757533</url>
  </required_header>
  <id_info>
    <org_study_id>182030</org_study_id>
    <nct_id>NCT03757533</nct_id>
  </id_info>
  <brief_title>Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease</brief_title>
  <official_title>Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease: A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      Inflammatory bowel disease (IBD) including Crohn's disease (CD) and Ulcerative colitis (UC)&#xD;
      is a chronic idiopathic intestinal disorder involving the interplay of environmental,&#xD;
      immunomodulatory and genetic causative factors. Treatment for IBD is multimodal and includes&#xD;
      lifestyle modification, chronic pharmacotherapy and surgery. Given the need for chronic&#xD;
      pharmacotherapy, medication adherence is a crucial therapeutic goal in the management of IBD.&#xD;
      In fact, medication non-adherence has been associated with greater risk of relapse and&#xD;
      increased healthcare costs.&#xD;
&#xD;
      In a previous study, the investigators found clinically identifiable risk factors for&#xD;
      non-adherence for self-injectable biologic medications in a population with moderate to&#xD;
      severe CD. These risk factors included smoking, prior biologic use, psychiatric history, and&#xD;
      current narcotic use. The primary objective of this study is to use a multidisciplinary team&#xD;
      approach that implements a targeted coaching intervention to promote behavioral change and&#xD;
      improve medication adherence in adult patients with IBD who are at high risk of&#xD;
      non-adherence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2019</start_date>
  <completion_date type="Actual">July 21, 2023</completion_date>
  <primary_completion_date type="Actual">July 21, 2023</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Adherence MPR</measure>
    <time_frame>24 months</time_frame>
    <description>Medication adherence will be measured using the medication possession ratio (MPR). MPR is calculated as the sum of days' supply for all prescription claims divided by the total number of days elapsed during that period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication Adherence PDC</measure>
    <time_frame>24 months</time_frame>
    <description>Medication adherence will be measured using the proportion of days covered (PDC). PDC is calculated as the number of days the patient has medication divided by the total number of days elapsed during that period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Health Coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Health Coaching (HC) arm will be assigned to a health coach for a period of 5 months along with receiving usual care (UC). An initial telephone call with the coach will include a discussion about the participant's self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, the participant schedules the remaining 9 biweekly sessions (30-45 minute in length), for a total of 10 coaching calls over 5 months. Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in the control arm will receive usual care (UC). Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record. To enhance recruitment, those subjects randomized to the usual care control group will be offered to participate in the health coaching arm of the study as well after a period of 6 months. If they refuse, they will continue in the usual care control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Coaching</intervention_name>
    <description>10 phone calls with a trained health coach</description>
    <arm_group_label>Health Coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surveys</intervention_name>
    <description>Surveys to assess Behavioural and Psychosocial measures</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Health Coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients treated at the Inflammatory Bowel Disease (IBD) clinic at Vanderbilt&#xD;
             with Crohn's disease or Ulcerative colitis confirmed by endoscopy or radiology&#xD;
             assessment&#xD;
&#xD;
          -  currently prescribed a biologic agent (self-injectable or infusion) for management of&#xD;
             IBD&#xD;
&#xD;
          -  medication dispensing is documented in patient medical record&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients less than 18 years of age&#xD;
&#xD;
          -  unstable clinical condition (bleeding, infection, intestinal obstruction, etc.)&#xD;
&#xD;
          -  patients who are required to get biologic medication at a specialty pharmacy outside&#xD;
             of Vanderbilt University that is not documented in medical record(exclusion due to&#xD;
             inability to accurately track prescription refills)&#xD;
&#xD;
          -  patients with short bowel syndrome, an ostomy, obstructive disease with strictures,&#xD;
             history of tuberculosis, hypersensitivity reaction to anti-TNF agent, cancer, renal&#xD;
             failure requiring specific treatment such as dialysis&#xD;
&#xD;
          -  patients with severe psychological comorbidity, defined as reported intent to&#xD;
             self-harm or harm others or psychiatric hospitalization in the past year&#xD;
&#xD;
          -  patients with current alcohol abuse or illegal drug use ascertained by medical history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sara Horst, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center Inflammatory Bowel Disease Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Sara Horst</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03757533
org study id: 182030
nct id: NCT03757533
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Inflammatory bowel disease (IBD) including Crohn's disease (CD) and Ulcerative colitis (UC)
      is a chronic idiopathic intestinal disorder involving the interplay of environmental,
      immunomodulatory and genetic causative factors. Treatment for IBD is multimodal and includes
      lifestyle modification, chronic pharmacotherapy and surgery. Given the need for chronic
      pharmacotherapy, medication adherence is a crucial therapeutic goal in the management of IBD.
      In fact, medication non-adherence has been associated with greater risk of relapse and
      increased healthcare costs.

      In a previous study, the investigators found clinically identifiable risk factors for
      non-adherence for self-injectable biologic medications in a population with moderate to
      severe CD. These risk factors included smoking, prior biologic use, psychiatric history, and
      current narcotic use. The primary objective of this study is to use a multidisciplinary team
      approach that implements a targeted coaching intervention to promote behavioral change and
      improve medication adherence in adult patients with IBD who are at high risk of
      non-adherence.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Medication Adherence MPR
time frame: 24 months
description: Medication adherence will be measured using the medication possession ratio (MPR). MPR is calculated as the sum of days' supply for all prescription claims divided by the total number of days elapsed during that period.
measure: Medication Adherence PDC
time frame: 24 months
description: Medication adherence will be measured using the proportion of days covered (PDC). PDC is calculated as the number of days the patient has medication divided by the total number of days elapsed during that period.
arm group label: Health Coaching
arm group type: Experimental
description: Participants in the Health Coaching (HC) arm will be assigned to a health coach for a period of 5 months along with receiving usual care (UC). An initial telephone call with the coach will include a discussion about the participant's self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, the participant schedules the remaining 9 biweekly sessions (30-45 minute in length), for a total of 10 coaching calls over 5 months. Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record.
arm group label: Control
arm group type: Other
description: Participants in the control arm will receive usual care (UC). Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record. To enhance recruitment, those subjects randomized to the usual care control group will be offered to participate in the health coaching arm of the study as well after a period of 6 months. If they refuse, they will continue in the usual care control group.
intervention type: Behavioral
intervention name: Health Coaching
description: 10 phone calls with a trained health coach
arm group label: Health Coaching
intervention type: Other
intervention name: Surveys
description: Surveys to assess Behavioural and Psychosocial measures
arm group label: Control
arm group label: Health Coaching
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sara Horst, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Sara Horst
investigator title: Principal Investigator
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No