<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/NCT02983877</url>
  </required_header>
  <id_info>
    <org_study_id>HL132364</org_study_id>
    <nct_id>NCT02983877</nct_id>
  </id_info>
  <brief_title>Medication Adherence in Hypertensive Individuals With Bipolar Disorder</brief_title>
  <acronym>iTAB-CV</acronym>
  <official_title>Improving Medication Adherence in Hypertensive Individuals With Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will test an adherence intervention (iTAB-CV) delivered via interactive text&#xD;
      messaging which first targets behavioral intent and then adds cues/reminders and&#xD;
      reinforcement to form the habit of taking antihypertensives in non-adherent individuals with&#xD;
      BD. Thirty eight individuals with BD and HTN being treated with evidence-based&#xD;
      antihypertensive agents and mood stabilizing or antipsychotic medications who are&#xD;
      non-adherent with their HTN medicine will be enrolled.&#xD;
&#xD;
      This study uses a prospective cohort design with participants serving as their own control.&#xD;
      Investigators will test the iTAB-CV intervention quantitatively for feasibility and&#xD;
      acceptability as well as for efficacy in increasing adherence to antihypertensives,&#xD;
      decreasing systolic blood pressure, and increasing adherence to BD medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will test an adherence intervention (iTAB-CV) delivered via interactive text&#xD;
      messaging which first targets behavioral intent and then adds cues/reminders and&#xD;
      reinforcement to form the habit of taking antihypertensives in non-adherent individuals with&#xD;
      BD. Thirty eight individuals with BD and HTN being treated with evidence-based&#xD;
      antihypertensive agents and mood stabilizing or antipsychotic medications who are&#xD;
      non-adherent with their HTN medicine will be enrolled.&#xD;
&#xD;
      This study uses a prospective cohort design with participants serving as their own control.&#xD;
      Investigators will test the iTAB-CV intervention quantitatively for feasibility and&#xD;
      acceptability as well as for efficacy in increasing adherence to antihypertensives,&#xD;
      decreasing systolic blood pressure, and increasing adherence to BD medication.&#xD;
&#xD;
      All study participants will be followed for a 3-month period. iTAB-CV, delivered via mobile&#xD;
      phone, is intended to be a brief adjunct to standard primary care and mental health&#xD;
      treatment. All individuals will continue to receive treatment as usual with their regular&#xD;
      provider(s). Individuals who meet eligibility criteria will have a 30 day run-in period in&#xD;
      which their medication adherence will be measured with TRQ and MEMS but without an additional&#xD;
      intervention. Following the run-in period, Stage 1 of the iTAB-CV intervention will be&#xD;
      introduced. Researchers will conduct an interview in order to customize iTAB-CV for each&#xD;
      participant at the baseline session. In the first month of iTAB-CV, participants will receive&#xD;
      alternating daily texts with psychoeducational and motivational content once daily and a&#xD;
      daily mood rating request to both monitor their mood and to determine engagement with the&#xD;
      iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts&#xD;
      which will include medication reminders, contextual cues, and immediate reinforcement for&#xD;
      medication taking behavior in addition to the content from stage 1.&#xD;
&#xD;
      Assessments that include evaluation of treatment adherence, psychiatric symptoms,&#xD;
      self-efficacy for medication taking behavior, illness beliefs, medication attitudes, and&#xD;
      habit strength for both antihypertensive and BD medications will be conducted at four time&#xD;
      points over a 3-month time period (screening, baseline/week 4, week 8, and week 12). Blood&#xD;
      pressure will be measured at each of the four contacts. Individuals who drop out of the&#xD;
      intervention, and who agree, will be followed up with outcomes assessments over the same&#xD;
      3-month time period that they would have been evaluated had they remained in the study.&#xD;
&#xD;
      About one month after study completion, a member of the research team will call each&#xD;
      participant and ask questions about their bipolar and blood pressure medication taking&#xD;
      habits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Actual">June 28, 2018</completion_date>
  <primary_completion_date type="Actual">June 4, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Following a 30 day run-in period, Stage 1 of the iTAB-CV intervention will be introduced. A member of the study team will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month of iTAB-CV, participants will receive alternating daily texts with psychoeducational and motivational content once daily and a daily mood rating request to both monitor their mood and to determine engagement with the iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)</measure>
    <time_frame>change from Screen (Week 0) to V2 (week 12)</time_frame>
    <description>This self-report measure identifies non-adherence for the past 7 days (Scott &amp; Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure</measure>
    <time_frame>change from Screen (Week 0) to V2 (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)</measure>
    <time_frame>change from Screen (Week 0) to V2 (week 12)</time_frame>
    <description>This self-report measure identifies non-adherence for the past 7 days (Scott &amp; Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single &quot;index&quot; drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)</measure>
    <time_frame>change from Baseline (Week 4) to V2 (week 12)</time_frame>
    <description>Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as &quot;taken&quot; if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Hypertension</condition>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>iTAB-CV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention. Stage 1 will last one month.&#xD;
In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 2, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from Stage 1. Stage 2 will last one month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iTAB-CV</intervention_name>
    <description>Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention.&#xD;
In the second stage for the following month, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.</description>
    <arm_group_label>iTAB-CV</arm_group_label>
    <other_name>Individualized Texting for Adherence Building-CV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Participants will have a clinical diagnosis of BD for at least 2 years as determined&#xD;
             by a standardized diagnostic interview, the Mini-International Neuropsychiatric&#xD;
             Interview (MINI) (52)&#xD;
&#xD;
          2. Have stage 1 or 2 HTN with a systolic pressure ≥130&#xD;
&#xD;
          3. Carry a diagnosis of HTN per patient self-report ≥ 6 months prior to enrollment&#xD;
&#xD;
          4. Have been prescribed at least one regularly scheduled antihypertensive medication for&#xD;
             ≥ 3 months since diagnosis&#xD;
&#xD;
          5. Have self-reported poor adherence to antihypertensive medication defined as at least&#xD;
             20% of days with missed doses for at least one antihypertensive in either the past&#xD;
             week or past month as identified by the Tablets Routine Questionnaire (TRQ).&#xD;
&#xD;
          6. Be able to participate in psychiatric interviews&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Unable or unwilling to participate in psychiatric interviews. This will include&#xD;
             individuals, who may be too psychotic to participate in interviews/rating scales&#xD;
&#xD;
          2. Unable or unwilling to give written, informed consent to study participation&#xD;
&#xD;
          3. Under the age of 21&#xD;
&#xD;
          4. In the interest of patient safety, individuals who are at high immediate risk for&#xD;
             suicide will be excluded from study participation. The suicide risk assessment will be&#xD;
             informed by standardized assessments of psychiatric symptoms and the&#xD;
             Mini-International Neuropsychiatric Interview (MINI). In the event that a potential&#xD;
             study participant is determined to be at high risk for suicide, that individual will&#xD;
             not be enrolled and the study staff will immediately implement procedures for the&#xD;
             safety of the individual. Once such individuals are deemed stable, they may be once&#xD;
             again considered for inclusion in the research.&#xD;
&#xD;
          5. Individuals who are monolingual, non-English speaking will be excluded. Given the&#xD;
             relatively small sample size in the proposed study, it would not be practical to&#xD;
             conduct sub-group analyses. Also, the study assessment tools and the texting&#xD;
             intervention are not available in other languages and would be impractical to develop.&#xD;
             Based upon our BD adherence work, which drew upon a population similar to the proposed&#xD;
             trial, there were no potential subjects who were excluded from the studies due to&#xD;
             inability to speak English.&#xD;
&#xD;
          6. Illiterate participants will be excluded because reading is an essential skill&#xD;
             required to complete self-report questionnaires administered during the study as well&#xD;
             as to respond to the text messages which make up the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Levin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center and Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <results_first_submitted>July 22, 2019</results_first_submitted>
  <results_first_submitted_qc>December 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 9, 2019</results_first_posted>
  <last_update_submitted>December 5, 2019</last_update_submitted>
  <last_update_submitted_qc>December 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Jennifer Levin</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02983877/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT02983877/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Thirty eight individuals with bipolar disorder (BD) and hypertension (HTN) being treated with evidence-based antihypertensive agents and mood stabilizing or antipsychotic medications who are nonadherent with their HTN medicine will be enrolled by referral. This phase uses a prospective cohort design with participants serving as their own control.</recruitment_details>
      <pre_assignment_details>After providing informed consent, all participants will undergo screening followed by a 30-day run-in period in which adherence will be measured using eCAP and self-report. During the 30-day run-in period, participants will continue to receive care as usual and serve as their own control with no intervention.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>iTAB-CV</title>
          <description>In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention. Stage 1 lasts one month.&#xD;
Stage two of iTAB-CV includes the addition of customized context cues/reminders and immediate reinforcement for medication taking behavior in addition to 1 daily motivational mood rating. The number of texts per day will be determined based on the number of times a day that medications are prescribed (up to four a day). Stage two lasts one month.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>iTAB-CV</title>
          <description>In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention.&#xD;
iTAB-CV Stage 1: Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.53" spread="9.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.18" spread="2.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Full time/homemaker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Part time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed, but expected to work by self or others</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disabled</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bipolar disorder type</title>
          <description>Baseline diagnostic assessment of type of bipolar disorder. Bipolar I Disorder is defined by manic episodes that last at least 7 days, or by manic symptoms that are so severe that the person needs immediate hospital care. Usually, depressive episodes occur as well, typically lasting at least 2 weeks. Episodes of depression with mixed features (having depression and manic symptoms at the same time) are also possible.&#xD;
Bipolar II Disorder is defined by a pattern of depressive episodes and hypomanic episodes, but not the full-blown manic episodes described above.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Bipolar Disorder Type I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bipolar Disorder Type II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age of hypertension diagnosis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.95" spread="15.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age of bipolar disorder diagnosis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.95" spread="13.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>hypertension-related hospitalizations</title>
          <description>Number of hypertension-related hospitalizations over participant's lifetime.</description>
          <population>Nineteen people endorsed having at least one hypertension-related hospitalization in their lifetime. Therefore, the median number of how many hospitalizations they had are based solely on those 19, to eliminate skewing of results of everyone who answered 0 lifetime hypertension-related hospitalizations.</population>
          <units>occurrences</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.16" lower_limit="1" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>substance use-related hospitalizations</title>
          <description>Number of hospitalizations related to substance use over the participant's lifetime.</description>
          <population>Twelve people endorsed having at least one hypertension-related hospitalization in their lifetime. Therefore, the median number of how many hospitalizations they had are based solely on those 12, to eliminate skewing of results of everyone who answered 0 lifetime substance use-related hospitalizations.</population>
          <units>occurrences</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.00" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of physical abuse</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of sexual abuse</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mental illness in the family</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smokes cigarettes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Median number of cigarettes smoked per day</title>
          <population>Twenty-three people endorsed being a cigarette smoker. Therefore, the median number of how many cigarettes smoked per day is based solely on those 23, to eliminate skewing of results of everyone who answered they are not cigarette smokers.</population>
          <units>cigarettes per day</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.00" lower_limit="1" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.15" spread="9.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)</title>
        <description>This self-report measure identifies non-adherence for the past 7 days (Scott &amp; Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.</description>
        <time_frame>change from Screen (Week 0) to V2 (week 12)</time_frame>
        <population>Baseline descriptives</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Sample</title>
            <description>These analyses were run on the entire sample as a whole, N= 38.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)</title>
          <description>This self-report measure identifies non-adherence for the past 7 days (Scott &amp; Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.</description>
          <population>Baseline descriptives</population>
          <units>percentage of days with missed doses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screen visit antihypertensive TRQ (past week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.86" spread="23.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V2 (week 12) antihypertensive TRQ (past week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.24" spread="17.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Friedman test</method>
            <method_desc>3 degrees of freedom</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Systolic Blood Pressure</title>
        <time_frame>change from Screen (Week 0) to V2 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Sample</title>
            <description>These analyses were run on the entire sample as a whole, N= 38.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screen visit systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.81" spread="15.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V2 (12 week) systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.02" spread="17.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>ANOVA</method>
            <method_desc>3 degrees of freedom</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)</title>
        <description>This self-report measure identifies non-adherence for the past 7 days (Scott &amp; Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single &quot;index&quot; drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included.</description>
        <time_frame>change from Screen (Week 0) to V2 (week 12)</time_frame>
        <population>Missing data for one participants (i.e. n= 37).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Sample</title>
            <description>These analyses were run on the entire sample as a whole. For this measure, two participants were missing data so the total N=36 instead of 38.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)</title>
          <description>This self-report measure identifies non-adherence for the past 7 days (Scott &amp; Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single &quot;index&quot; drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included.</description>
          <population>Missing data for one participants (i.e. n= 37).</population>
          <units>percentage of days with missed doses</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screen visit bipolar medication TRQ (past week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.95" spread="27.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V2 (12 week) bipolar medication TRQ (past week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.86" spread="23.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Friedman test</method>
            <method_desc>3 degrees of freedom</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)</title>
        <description>Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as &quot;taken&quot; if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.</description>
        <time_frame>change from Baseline (Week 4) to V2 (week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Whole Sample</title>
            <description>These analyses were run on the entire sample as a whole, N= 38.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)</title>
          <description>Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as &quot;taken&quot; if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.</description>
          <units>percentage of medications missed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline visit antihypertensive eCAP (past week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.70" spread="28.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>V2 (12 week) antihypertensive eCAP (past week)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.75" spread="28.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.89</p_value>
            <method>ANOVA</method>
            <method_desc>2 degrees of freedom</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>iTAB-CV</title>
          <description>Participants received alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>high blood pressure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>stomach pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>swollen legs</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>suicidal thoughts</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>kidney stones</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Voluntary alcohol rehab at VA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jennifer Levin</name_or_title>
      <organization>Case Western Reserve University</organization>
      <phone>2168445057</phone>
      <email>jennifer.levin@uhhospitals.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02983877
org study id: HL132364
nct id: NCT02983877
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will test an adherence intervention (iTAB-CV) delivered via interactive text
      messaging which first targets behavioral intent and then adds cues/reminders and
      reinforcement to form the habit of taking antihypertensives in non-adherent individuals with
      BD. Thirty eight individuals with BD and HTN being treated with evidence-based
      antihypertensive agents and mood stabilizing or antipsychotic medications who are
      non-adherent with their HTN medicine will be enrolled.

      This study uses a prospective cohort design with participants serving as their own control.
      Investigators will test the iTAB-CV intervention quantitatively for feasibility and
      acceptability as well as for efficacy in increasing adherence to antihypertensives,
      decreasing systolic blood pressure, and increasing adherence to BD medication.
This study will test an adherence intervention (iTAB-CV) delivered via interactive text
      messaging which first targets behavioral intent and then adds cues/reminders and
      reinforcement to form the habit of taking antihypertensives in non-adherent individuals with
      BD. Thirty eight individuals with BD and HTN being treated with evidence-based
      antihypertensive agents and mood stabilizing or antipsychotic medications who are
      non-adherent with their HTN medicine will be enrolled.

      This study uses a prospective cohort design with participants serving as their own control.
      Investigators will test the iTAB-CV intervention quantitatively for feasibility and
      acceptability as well as for efficacy in increasing adherence to antihypertensives,
      decreasing systolic blood pressure, and increasing adherence to BD medication.

      All study participants will be followed for a 3-month period. iTAB-CV, delivered via mobile
      phone, is intended to be a brief adjunct to standard primary care and mental health
      treatment. All individuals will continue to receive treatment as usual with their regular
      provider(s). Individuals who meet eligibility criteria will have a 30 day run-in period in
      which their medication adherence will be measured with TRQ and MEMS but without an additional
      intervention. Following the run-in period, Stage 1 of the iTAB-CV intervention will be
      introduced. Researchers will conduct an interview in order to customize iTAB-CV for each
      participant at the baseline session. In the first month of iTAB-CV, participants will receive
      alternating daily texts with psychoeducational and motivational content once daily and a
      daily mood rating request to both monitor their mood and to determine engagement with the
      iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts
      which will include medication reminders, contextual cues, and immediate reinforcement for
      medication taking behavior in addition to the content from stage 1.

      Assessments that include evaluation of treatment adherence, psychiatric symptoms,
      self-efficacy for medication taking behavior, illness beliefs, medication attitudes, and
      habit strength for both antihypertensive and BD medications will be conducted at four time
      points over a 3-month time period (screening, baseline/week 4, week 8, and week 12). Blood
      pressure will be measured at each of the four contacts. Individuals who drop out of the
      intervention, and who agree, will be followed up with outcomes assessments over the same
      3-month time period that they would have been evaluated had they remained in the study.

      About one month after study completion, a member of the research team will call each
      participant and ask questions about their bipolar and blood pressure medication taking
      habits.
intervention model: Sequential Assignment
intervention model description: Following a 30 day run-in period, Stage 1 of the iTAB-CV intervention will be introduced. A member of the study team will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month of iTAB-CV, participants will receive alternating daily texts with psychoeducational and motivational content once daily and a daily mood rating request to both monitor their mood and to determine engagement with the iTAB-CV intervention. In the second stage of iTAB-CV, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)
time frame: change from Screen (Week 0) to V2 (week 12)
description: This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.
measure: Change in Systolic Blood Pressure
time frame: change from Screen (Week 0) to V2 (week 12)
measure: Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)
time frame: change from Screen (Week 0) to V2 (week 12)
description: This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single "index" drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included.
measure: Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)
time frame: change from Baseline (Week 4) to V2 (week 12)
description: Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as "taken" if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription.
arm group label: iTAB-CV
arm group type: Experimental
description: In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 1, participants will receive alternating daily texts with educational and motivational content on treatment for high blood pressure and bipolar disorder, and a daily mood rating request to both monitor their mood and to determine adherence to iTAB-CV intervention. Stage 1 will last one month.
In the Individualized Texting for Adherence Building-CV (iTAB-CV) Stage 2, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from Stage 1. Stage 2 will last one month.
intervention type: Behavioral
intervention name: iTAB-CV
description: Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention.
In the second stage for the following month, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1.
arm group label: iTAB-CV
other name: Individualized Texting for Adherence Building-CV
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jennifer Levin, PhD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Jennifer Levin
investigator title: Associate Professor
mesh term: Bipolar Disorder
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 