<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/NCT01702883</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00020789</org_study_id>
    <nct_id>NCT01702883</nct_id>
  </id_info>
  <brief_title>The Medication Experience Study</brief_title>
  <official_title>Using an Internet Survey to Improve Patient Adherence in Chronic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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 purpose of this study is to evaluate whether participation in an Internet-based&#xD;
      intervention helps improve medication use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary measure will be adherence as measured by pharmacy refills in each group.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Hypertension</condition>
  <condition>Elevated Cholesterol</condition>
  <condition>Diabetes</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Randomization occurs after enrollment survey has been completed. This group will not receive the internet intervention for the twelve months. They will be asked to complete the final survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomization occurs after enrollment survey has been completed. Upon secondary randomization at week eight, this group will continue to receive weekly internet surveys for the entire twelve months. They will be asked to complete the final survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, this group will begin to receive monthly internet surveys. They will be asked to complete the final survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, the group will not receive any more internet surveys. They will be asked to complete the final survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet Survey</intervention_name>
    <description>prompt to complete internet survey</description>
    <arm_group_label>Intervention Group A</arm_group_label>
    <arm_group_label>Intervention Group B</arm_group_label>
    <arm_group_label>Intervention Group C</arm_group_label>
    <other_name>internet surveys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any male or female 18 years or older, filling prescriptions for oral medications for&#xD;
             hypertension, high cholesterol, diabetes, or depression at the Downtown Health Plaza,&#xD;
             Piedmont Plaza, or Cancer Center Pharmacies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to complete Internet surveys due to inadequate Internet access, not&#xD;
             understanding a survey written in English, or lack of computer skills.&#xD;
&#xD;
          -  Patient does not intend to continue using the same WFBMC-affiliated pharmacy for the&#xD;
             next 12 months.&#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>Steve R Feldman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</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>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prescriptions</keyword>
  <keyword>hypertension</keyword>
  <keyword>high cholesterol</keyword>
  <keyword>diabetes</keyword>
  <keyword>depression</keyword>
  <keyword>adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Depression</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/NCT01702883
org study id: IRB00020789
nct id: NCT01702883
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate whether participation in an Internet-based
      intervention helps improve medication use.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: The primary measure will be adherence as measured by pharmacy refills in each group.
time frame: 12 months
arm group label: Control
arm group type: No Intervention
description: Randomization occurs after enrollment survey has been completed. This group will not receive the internet intervention for the twelve months. They will be asked to complete the final survey.
arm group label: Intervention Group A
arm group type: Experimental
description: Randomization occurs after enrollment survey has been completed. Upon secondary randomization at week eight, this group will continue to receive weekly internet surveys for the entire twelve months. They will be asked to complete the final survey.
arm group label: Intervention Group B
arm group type: Experimental
description: Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, this group will begin to receive monthly internet surveys. They will be asked to complete the final survey.
arm group label: Intervention Group C
arm group type: Experimental
description: Randomization occurs after enrollment survey has been completed. This group will complete weekly internet surveys for eight weeks. Upon secondary randomization at week eight, the group will not receive any more internet surveys. They will be asked to complete the final survey.
intervention type: Other
intervention name: Internet Survey
description: prompt to complete internet survey
arm group label: Intervention Group A
arm group label: Intervention Group B
arm group label: Intervention Group C
other name: internet surveys
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steve R Feldman, MD, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Hypercholesterolemia
mesh term: Depression