<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/NCT02251080</url>
  </required_header>
  <id_info>
    <org_study_id>00026657</org_study_id>
    <nct_id>NCT02251080</nct_id>
  </id_info>
  <brief_title>Attention Deficit/Hyperactivity Disorder Internet Survey Study in a College Student Population</brief_title>
  <official_title>Attention Deficit/Hyperactivity Disorder (ADHD) Internet Survey Study in a College Student Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There&#xD;
      are many safe oral therapies that require daily use to be effective. Because frequent&#xD;
      follow-up visits have been shown to increase adherence to medication, we will determine if&#xD;
      adherence to oral therapy for ADHD will improve with an intervention involving weekly&#xD;
      internet-based contact without an office visit.&#xD;
&#xD;
      The primary aim is to determine the effectiveness of an Internet-based survey in improving&#xD;
      adherence to therapy for ADHD. Subjects in this study will be either receive a weekly&#xD;
      Internet-based survey assessing the prescribed medication and their ADHD, or to receive&#xD;
      standard-of-care therapy in which they will take their medication. The following hypothesis&#xD;
      is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD&#xD;
      medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an investigator-blinded, prospective study of subjects diagnosed with ADHD.Forty-four&#xD;
      subjects ages 18 years and older will be enrolled. An Internet-based survey will be piloted&#xD;
      to evaluate its effect on adherence to oral ADHD medication. Subjects randomized in a 1:1&#xD;
      ratio to the Internet-survey group will log their impression of the state of their disease on&#xD;
      a weekly basis. Subjects in both the intervention and control groups will receive&#xD;
      standard-of-care medication, stimulants. Adherence to the medication will be assessed using&#xD;
      Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the&#xD;
      medication containers. Investigators and subjects will be blinded to the adherence data until&#xD;
      the final (Month 2) treatment visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Compared measured adherence of Internet survey group to standard-of-care group</measure>
    <time_frame>after one month; 2 months of commencing the study</time_frame>
    <description>All subjects will be prescribed the standard-of-care treatment for ADHD, a stimulant. Adherence to standard-of-care medication for ADHD will be objectively measured using a bottle fitted with a Medication Monitoring System (MEMS®) cap and the percentage doses taken will be report as outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey</measure>
    <time_frame>2 months</time_frame>
    <description>The Internet survey results of all subjects randomized to receive the Internet survey will be compared to their measured adherence by the MEMS® cap.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease severity</measure>
    <time_frame>baseline; month 1, month 2</time_frame>
    <description>Using validated measures the assessments will be done at baseline, month1, and month 2(end of study). Disease severity will be measured by DSM-V classification and by the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Internet-based Survey</arm_group_label>
    <description>Assessments completed over the 2-month study will include: disease severity as measured by DSM-V classification and by several validated measures including the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales; adherence measures (MEMS® and pill counts); validated medication satisfaction measure (the Treatment Satisfaction Questionnaire for Medication); and quality of life measured using the validated WHO Quality of Life Brief measure (WHOQOL-BREF); and responses to a weekly Internet-based questionnaire of adherence and disease severity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-of-Care</arm_group_label>
    <description>Assessments completed over the 2-month study will include: disease severity as measured by DSM-V classification and by several validated measures including the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales; adherence measures (MEMS® and pill counts); validated medication satisfaction measure (the Treatment Satisfaction Questionnaire for Medication); and quality of life measured using the validated WHO Quality of Life Brief measure (WHOQOL-BREF);</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 44 male and female subjects ages 18 and over with ADHD and who are filling&#xD;
        the medication at the Wake Forest University Student Health Center pharmacy will be&#xD;
        eligible for recruitment. Subjects will be recruited from the Wake Forest University&#xD;
        Student Health Center at their clinic visit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any male or female 18 years or older of age with a diagnosis of mild to severe ADHD by&#xD;
             a psychiatrist at Wake Forest University Student Health Clinic&#xD;
&#xD;
          -  Use of the Wake Forest University Student Health Clinic Pharmacy to fill medication&#xD;
             for ADHD&#xD;
&#xD;
          -  Subject is a good candidate to receive a stimulant for the treatment of their ADHD&#xD;
&#xD;
          -  Subject is capable of understanding and willing to provide a signed and dated written&#xD;
             voluntary informed consent before any protocol specific procedures are performed&#xD;
&#xD;
          -  The subject is able to complete the study and comply with study instructions,&#xD;
             including attending all study visits&#xD;
&#xD;
          -  Will be filling a prescription for ADHD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is less than 18 years of age&#xD;
&#xD;
          -  Inability to complete all study-related visits or inability to complete the Internet&#xD;
             survey due to inadequate Internet access&#xD;
&#xD;
          -  Patients who are homicidal, suicidal, or psychotic&#xD;
&#xD;
          -  Female patients whose medications may be harmful during pregnancy must be on an&#xD;
             acceptable form of birth control, otherwise they will not be eligible for&#xD;
             participation&#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>Guy K. Palmes, MD</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>December 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>April 18, 2017</last_update_submitted>
  <last_update_submitted_qc>April 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adherence</keyword>
  <keyword>internet-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</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/NCT02251080
org study id: 00026657
nct id: NCT02251080
lead sponsor: 
has dmc: No
Attention Deficit/Hyperactivity Disorder (ADHD) is a common condition in young adults. There
      are many safe oral therapies that require daily use to be effective. Because frequent
      follow-up visits have been shown to increase adherence to medication, we will determine if
      adherence to oral therapy for ADHD will improve with an intervention involving weekly
      internet-based contact without an office visit.

      The primary aim is to determine the effectiveness of an Internet-based survey in improving
      adherence to therapy for ADHD. Subjects in this study will be either receive a weekly
      Internet-based survey assessing the prescribed medication and their ADHD, or to receive
      standard-of-care therapy in which they will take their medication. The following hypothesis
      is to be tested: A weekly Internet survey will promote improved adherence to oral ADHD
      medications.
This is an investigator-blinded, prospective study of subjects diagnosed with ADHD.Forty-four
      subjects ages 18 years and older will be enrolled. An Internet-based survey will be piloted
      to evaluate its effect on adherence to oral ADHD medication. Subjects randomized in a 1:1
      ratio to the Internet-survey group will log their impression of the state of their disease on
      a weekly basis. Subjects in both the intervention and control groups will receive
      standard-of-care medication, stimulants. Adherence to the medication will be assessed using
      Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the
      medication containers. Investigators and subjects will be blinded to the adherence data until
      the final (Month 2) treatment visit.
observational model: Cohort
time perspective: Prospective
measure: Compared measured adherence of Internet survey group to standard-of-care group
time frame: after one month; 2 months of commencing the study
description: All subjects will be prescribed the standard-of-care treatment for ADHD, a stimulant. Adherence to standard-of-care medication for ADHD will be objectively measured using a bottle fitted with a Medication Monitoring System (MEMS®) cap and the percentage doses taken will be report as outcome.
measure: Measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey
time frame: 2 months
description: The Internet survey results of all subjects randomized to receive the Internet survey will be compared to their measured adherence by the MEMS® cap.
measure: Change in disease severity
time frame: baseline; month 1, month 2
description: Using validated measures the assessments will be done at baseline, month1, and month 2(end of study). Disease severity will be measured by DSM-V classification and by the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales.
arm group label: Internet-based Survey
description: Assessments completed over the 2-month study will include: disease severity as measured by DSM-V classification and by several validated measures including the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales; adherence measures (MEMS® and pill counts); validated medication satisfaction measure (the Treatment Satisfaction Questionnaire for Medication); and quality of life measured using the validated WHO Quality of Life Brief measure (WHOQOL-BREF); and responses to a weekly Internet-based questionnaire of adherence and disease severity.
arm group label: Standard-of-Care
description: Assessments completed over the 2-month study will include: disease severity as measured by DSM-V classification and by several validated measures including the ADHD Rating Scale IV with adult prompts, and Clinical Global Impressions, severity and improvement scales; adherence measures (MEMS® and pill counts); validated medication satisfaction measure (the Treatment Satisfaction Questionnaire for Medication); and quality of life measured using the validated WHO Quality of Life Brief measure (WHOQOL-BREF);
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guy K. Palmes, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity