<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/NCT01714141</url>
  </required_header>
  <id_info>
    <org_study_id>MCTI-1R34HL107664-01A1</org_study_id>
    <nct_id>NCT01714141</nct_id>
  </id_info>
  <brief_title>Multi-Component Technology Intervention for Minority Emerging Adults With Asthma</brief_title>
  <official_title>Multi-Component Technology Intervention for Minority Emerging Adults With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study's main goal is to develop and preliminarily test a technology-based&#xD;
      intervention to improve asthma medication adherence in urban African American emerging adults&#xD;
      (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show&#xD;
      improvements in motivation to adhere to asthma medications and self-reported adherence&#xD;
      compared to the comparison condition at 1- and 3- month follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study collected pilot data with a sample of 48 African American emerging adults with&#xD;
      asthma with suboptimal medication adherence. Half of the sample were randomized to receive a&#xD;
      multi-component technology-based intervention (MCTI) targeting adherence to daily controller&#xD;
      medication. The MCTI consisted of two components: 1) 2 sessions of computer-delivered&#xD;
      motivational interviewing targeting medication adherence, and 2) individualized text&#xD;
      messaging focused on medication adherence between the sessions. Text messages were&#xD;
      individualized based on Ecological Momentary Assessment (EMA). The remaining half of&#xD;
      participants completed a series of computer-delivered asthma education modules matched for&#xD;
      length, location, and method of delivery of the intervention session. Control participants&#xD;
      also received text messages between intervention sessions. Message content was the same for&#xD;
      all control participants and contain general facts about asthma (not tailored).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in medication adherence</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Self-reported adherence to asthma controller medication(s) through questionnaire report and, at baseline and 3 months, 7 days of momentary (real time) sampling of adherence behavior via SMS text messaging.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in motivation for medication adherence</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Self-report of motivation to take asthma controller medications as prescribed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in asthma knowledge</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Knowledge of asthma and asthma medications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma medication confidence</measure>
    <time_frame>Baseline, 1 month, 3 month</time_frame>
    <description>Confidence in ability to take asthma medications as prescribed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma medication importance</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Perceived importance of taking asthma medication as prescribed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma control</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Self-reported asthma control (symptom prevalence, health care utilization)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in barriers to taking medication</measure>
    <time_frame>baseline, 1 month, 3 months</time_frame>
    <description>Self-report of barriers to taking medication. At baseline and 3 months, daily barriers to taking medications as reported in daily diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma anxiety</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Feelings and anxiety associated with living with asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma self-efficacy and attitude</measure>
    <time_frame>baseline, 1 month, 3 month</time_frame>
    <description>Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Asthma</condition>
  <condition>Poor Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Multi-component, technology based intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 tailored, computer-delivered motivational interviewing sessions targeting adherence to asthma control medications + tailored text messaged reminders to take medications between sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asthma education active control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control condition consists of active control matched to intervention for delivery-method and time-- 2 sessions of computer-delivered asthma education + daily text messaged facts about asthma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multi-component, technology based intervention</intervention_name>
    <description>Motivational sessions were adapted from work done with young adults with HIV (MESA).</description>
    <arm_group_label>Multi-component, technology based intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Asthma education active control</intervention_name>
    <arm_group_label>Asthma education active control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        African American Live in the Detroit Area, approximately 30 miles from the Hutzel Building&#xD;
        Ages 18-29&#xD;
&#xD;
        Have moderate to severe persistent asthma. Persistent asthma is defined according to the&#xD;
        2007 NHLBI guidelines. The level of symptoms, as defined by any of the following in the&#xD;
        last 4 weeks:&#xD;
&#xD;
        Use of any asthma medication more than 2 times a week Daytime asthma symptoms such as&#xD;
        wheezing, tightness of chest, problems coughing more than 2 times a week, or waking up at&#xD;
        night because of asthma more than 2 times a month&#xD;
&#xD;
        Participant is prescribed a daily asthma controller medication, even if they do not take&#xD;
        it.&#xD;
&#xD;
        Participant must report poor adherence to daily controller medications during eligibility&#xD;
        screening (brief interview).&#xD;
&#xD;
        Poor adherence is defined as not taking medications &quot;as prescribed&quot; less than 4 days per&#xD;
        week in any of the 4 weeks prior to enrollment OR as a proxy of poor adherence as&#xD;
        self-report of &lt;80% medication adherence in the past 30 days, self-report of emergency room&#xD;
        visit/hospitalization for asthma in the past 6 months, or a poor score on the Asthma&#xD;
        Control Test.&#xD;
&#xD;
        Participant must be able to complete questionnaires in English Participant must own or have&#xD;
        access to a cellular phone for the duration of the study No exclusions will be made due to&#xD;
        co-morbid mental health problems (i.e. ADHD, depression) except thought disorders (i.e.&#xD;
        schizophrenia, autism), suicidality or mental retardation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals with other chronic health conditions requiring ongoing medical intervention (&#xD;
        e.g., HIV, Type II Diabetes) will be excluded.&#xD;
&#xD;
        These chronic diseases include: Glaucoma, bi-polarism, segmented glomerular nephritis,&#xD;
        cystic fibrosis, spondyloarthropathy, congenital heart disease, sickle cell&#xD;
&#xD;
        No pregnant women will be included in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.</citation>
    <PMID>27475032</PMID>
  </results_reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>October 31, 2016</last_update_submitted>
  <last_update_submitted_qc>October 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Karen MacDonell, PhD</investigator_full_name>
    <investigator_title>Assistante Professor</investigator_title>
  </responsible_party>
  <keyword>Technology based intervention</keyword>
  <keyword>Emerging adults</keyword>
  <keyword>African Americans</keyword>
  <keyword>Asthma</keyword>
  <keyword>Controller medications</keyword>
  <keyword>Motivational intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT01714141
org study id: MCTI-1R34HL107664-01A1
nct id: NCT01714141
lead sponsor: 
has dmc: Yes
This pilot study's main goal is to develop and preliminarily test a technology-based
      intervention to improve asthma medication adherence in urban African American emerging adults
      (ages 18-29). It is hypothesized that youth randomized to MCTI for adherence will show
      improvements in motivation to adhere to asthma medications and self-reported adherence
      compared to the comparison condition at 1- and 3- month follow up.
This study collected pilot data with a sample of 48 African American emerging adults with
      asthma with suboptimal medication adherence. Half of the sample were randomized to receive a
      multi-component technology-based intervention (MCTI) targeting adherence to daily controller
      medication. The MCTI consisted of two components: 1) 2 sessions of computer-delivered
      motivational interviewing targeting medication adherence, and 2) individualized text
      messaging focused on medication adherence between the sessions. Text messages were
      individualized based on Ecological Momentary Assessment (EMA). The remaining half of
      participants completed a series of computer-delivered asthma education modules matched for
      length, location, and method of delivery of the intervention session. Control participants
      also received text messages between intervention sessions. Message content was the same for
      all control participants and contain general facts about asthma (not tailored).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in medication adherence
time frame: baseline, 1 month, 3 month
description: Self-reported adherence to asthma controller medication(s) through questionnaire report and, at baseline and 3 months, 7 days of momentary (real time) sampling of adherence behavior via SMS text messaging.
measure: Change in motivation for medication adherence
time frame: baseline, 1 month, 3 month
description: Self-report of motivation to take asthma controller medications as prescribed.
measure: Change in asthma knowledge
time frame: baseline, 1 month, 3 month
description: Knowledge of asthma and asthma medications
measure: Change in asthma medication confidence
time frame: Baseline, 1 month, 3 month
description: Confidence in ability to take asthma medications as prescribed.
measure: Change in asthma medication importance
time frame: baseline, 1 month, 3 month
description: Perceived importance of taking asthma medication as prescribed.
measure: Change in asthma control
time frame: baseline, 1 month, 3 month
description: Self-reported asthma control (symptom prevalence, health care utilization)
measure: Change in barriers to taking medication
time frame: baseline, 1 month, 3 months
description: Self-report of barriers to taking medication. At baseline and 3 months, daily barriers to taking medications as reported in daily diary.
measure: Change in asthma anxiety
time frame: baseline, 1 month, 3 month
description: Feelings and anxiety associated with living with asthma.
measure: Change in asthma self-efficacy and attitude
time frame: baseline, 1 month, 3 month
description: Self-report of self-efficacy to manage asthma effectively; attitude towards asthma and asthma management.
arm group label: Multi-component, technology based intervention
arm group type: Experimental
description: 2 tailored, computer-delivered motivational interviewing sessions targeting adherence to asthma control medications + tailored text messaged reminders to take medications between sessions.
arm group label: Asthma education active control
arm group type: Active Comparator
description: Control condition consists of active control matched to intervention for delivery-method and time-- 2 sessions of computer-delivered asthma education + daily text messaged facts about asthma.
intervention type: Behavioral
intervention name: Multi-component, technology based intervention
description: Motivational sessions were adapted from work done with young adults with HIV (MESA).
arm group label: Multi-component, technology based intervention
intervention type: Behavioral
intervention name: Asthma education active control
arm group label: Asthma education active control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: No
citation: Kolmodin MacDonell K, Naar S, Gibson-Scipio W, Lam P, Secord E. The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults. J Adolesc Health. 2016 Oct;59(4):465-71. doi: 10.1016/j.jadohealth.2016.05.016. Epub 2016 Jul 27.
PMID: 27475032
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Karen MacDonell, PhD
investigator title: Assistante Professor
mesh term: Asthma