<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/NCT03292393</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-15-0196</org_study_id>
    <nct_id>NCT03292393</nct_id>
  </id_info>
  <brief_title>Social Norms and Antihypertensive Medication Adherence</brief_title>
  <official_title>Social Norms and Antihypertensive Medication Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida International University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study objective is to build group social norms to improve individual adhere to&#xD;
      antihypertensive medications. Financial incentives are provided to individuals contingent&#xD;
      upon group behavioral changes. Groups of patients will be formed, and incentivized to&#xD;
      interact on a daily basis through social media and participate in a monthly-facilitated&#xD;
      meeting at a local clinic. By forming groups, making individual outcomes transparent, and&#xD;
      setting financial incentives contingent to group targets, individual decisions are framed&#xD;
      within emerging social norms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We propose a pilot study that will inform, provide inputs and reduce the risk of a larger&#xD;
      implementation. The project consists of three phases: The pre-intervention phase, the&#xD;
      intervention phase, and the post-intervention phase. The pre-intervention phase includes the&#xD;
      recruitment and selection of participants, and a one-month collection of baseline blood&#xD;
      pressure and medication adherence levels of participants before they are assigned to a&#xD;
      treatment arm. All participants will receive compensation for participation.&#xD;
&#xD;
      In the intervention phase participants will be randomly assigned to one of the three&#xD;
      treatment arms and they will receive the financial incentive that corresponds to their&#xD;
      treatment arm. Data will be collected for four months and all participants will continue&#xD;
      receiving a compensation for participation.&#xD;
&#xD;
      During the post-intervention phase, contingency payments will be cut off, and only&#xD;
      compensation for participation will remain. Data will be collected for three months in the&#xD;
      post-intervention phase.&#xD;
&#xD;
      The primary outcome of the study is medication adherence which will be measured using two&#xD;
      different methods. The first method is through the use of eCaps (electronic caps). The second&#xD;
      method is through a monthly randomized phone call during which the participant will be asked&#xD;
      to perform a pill count of their medication.&#xD;
&#xD;
      The secondary outcome of the study is blood pressure which will be measured using two&#xD;
      different instruments . The first instrument will be the ambulatory blood pressure monitor&#xD;
      (ABPM). The second instrument will be a home blood pressure monitor (HBPM) which researchers&#xD;
      will provide to the participant to use for the duration of the study.&#xD;
&#xD;
      All participants of the study will receive an unconditional payment each time they provide a&#xD;
      blood pressure reading from the ABPM. Financial incentives (contingent to change in behavior&#xD;
      -conditional to change in adherence). In addition to the unconditional payment, participants&#xD;
      in the ICM and GCM treatment arms will receive a financial incentive that is conditional to&#xD;
      medication adherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not enough sample list at participating healthcare facility.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self Assessed Medication Adherence</measure>
    <time_frame>Monthly over 8 months</time_frame>
    <description>Use self reported personal pill count to calculate the Medication Possession Ratio score, this ratio is explained in the protocol and can explain how multiple measurements will be aggregated to arrive at one reported value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self Assessed Diastolic Blood pressure (mm Hg)</measure>
    <time_frame>Monthly over 8 months</time_frame>
    <description>Self blood diastolic pressure reading with the HBPM device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Automatic measure of Medication Adherence</measure>
    <time_frame>Daily over 8 months</time_frame>
    <description>Use the Research Electronic Data Capture (REDCap) system to gather a pill count to calculate the Medication Possession Ratio score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self Assessed Systolic Blood pressure (mm Hg)</measure>
    <time_frame>Monthly over 8 months</time_frame>
    <description>Self blood systolic pressure reading with the HBPM device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Automatic measure of Diastolic Blood pressure (mm Hg)</measure>
    <time_frame>Three times over 8 months</time_frame>
    <description>Blood Diastolic pressure reading with the ABPM device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Automatic measure of Systolic Blood pressure (mm Hg)</measure>
    <time_frame>Three times over 8 months</time_frame>
    <description>Blood Systolic pressure reading with the ABPM device.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hypertension</condition>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Group Contingency Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the intervention phase, the Group Contingency Management (GCM) arm will continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a home blood pressure monitoring reading using the HBPM. Participants in the GCM arm will receive a payment after each phone call, dependent on their medication adherence assessment. The GCM arm will also receive an additional payment based on their group's medication adherence.The intervention administered is the Financial Reward and Social Norms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual Contingency Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the intervention phase, those in the Individual Contingency Management (ICM) arm will also continue to take their hypertensive medication for the four-month period but will receive a payment after each phone call, dependent on their medication adherence assessment.The intervention administered is the Financial Reward.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the intervention phase, those in the control arm will be asked to continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a blood pressure reading using the HBPM. Those in the control arm will only be paid for their participation in the study regardless of medication adherence assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial reward</intervention_name>
    <description>In contingency management, financial rewards are contingent upon an individual changing behavior. In our study, financial incentives are contingent upon group behavioral changes.. In the intervention phase participants will be randomly assigned to one of the three treatment arms and they will receive the financial incentive that corresponds to their treatment arm. Data will be collected for four months and all participants will continue receiving a compensation for participation</description>
    <arm_group_label>Group Contingency Management</arm_group_label>
    <arm_group_label>Individual Contingency Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social norms</intervention_name>
    <description>To build social norms the study adds a group component to a contingency management model. In contingency management, financial rewards are contingent upon an individual changing behavior. Social norms are expected to emerge as a result of the designed group contingency management, monthly-facilitated meetings at a local clinic, and daily basis interaction through social media. The intervention will build social norms that improve medication adherence of each member of a group. A three-arm randomize trial is designed to test this hypothesis. Hypertensive patients will be randomly assigned to a group contingency management (GCM) arm, an individual contingency management (ICG) arm, or a control arm.</description>
    <arm_group_label>Group Contingency Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Home Blood Pressure Monitoring</intervention_name>
    <description>Participants will be reminded that they will receive and learn how to use a Home Blood Pressure Monitor (HBPM) device that participant will keep for the duration of the study</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Group Contingency Management</arm_group_label>
    <arm_group_label>Individual Contingency Management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medication adherence assessment</intervention_name>
    <description>Participants will be informed that they will receive and learn how to use eCap, a medication event monitoring system that participants will return after completing the study. The project nursing student will count the number of pills the participant currently has and make a record of it on the Data Collection form.The participant will provide the project nursing student with his/her antihypertension prescription records so that the dosage amount and number of pills can be recorded on the Data Collection form.</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Group Contingency Management</arm_group_label>
    <arm_group_label>Individual Contingency Management</arm_group_label>
    <other_name>eCap</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person has been diagnosed with essential hypertension for at least a year (no new or&#xD;
             recently diagnosed hypertensive patients)&#xD;
&#xD;
          -  Person is currently taking no more than 2 medications&#xD;
&#xD;
          -  Person has taken the same anti-hypertensive medication for at least a year (no recent&#xD;
             changes in medication)&#xD;
&#xD;
          -  Person reports not being adherent to anti-hypertensive medication&#xD;
&#xD;
          -  Speaks English or Spanish, currently insured&#xD;
&#xD;
          -  Has access to the Internet&#xD;
&#xD;
          -  Willing to participate in social media, able to go to West Kendall Baptist Hospital&#xD;
&#xD;
          -  Available for the next 8 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons with Secondary hypertension&#xD;
&#xD;
          -  Persons with coronary heart disease, cerebrovascular disorders or atrial fibrillation,&#xD;
&#xD;
          -  Persons with rubber allergy, or bedridden, wheelchair bound.&#xD;
&#xD;
          -  Persons who have had a stroke or myocardial infarction within the previous 6 months,&#xD;
             are pregnant, or have any serious chronic disease will also be excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alejandro Arrieta, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida International University</affiliation>
  </overall_official>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>February 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>November 6, 2018</last_update_submitted>
  <last_update_submitted_qc>November 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Medication</keyword>
  <keyword>Adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03292393
org study id: IRB-15-0196
nct id: NCT03292393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study objective is to build group social norms to improve individual adhere to
      antihypertensive medications. Financial incentives are provided to individuals contingent
      upon group behavioral changes. Groups of patients will be formed, and incentivized to
      interact on a daily basis through social media and participate in a monthly-facilitated
      meeting at a local clinic. By forming groups, making individual outcomes transparent, and
      setting financial incentives contingent to group targets, individual decisions are framed
      within emerging social norms.
We propose a pilot study that will inform, provide inputs and reduce the risk of a larger
      implementation. The project consists of three phases: The pre-intervention phase, the
      intervention phase, and the post-intervention phase. The pre-intervention phase includes the
      recruitment and selection of participants, and a one-month collection of baseline blood
      pressure and medication adherence levels of participants before they are assigned to a
      treatment arm. All participants will receive compensation for participation.

      In the intervention phase participants will be randomly assigned to one of the three
      treatment arms and they will receive the financial incentive that corresponds to their
      treatment arm. Data will be collected for four months and all participants will continue
      receiving a compensation for participation.

      During the post-intervention phase, contingency payments will be cut off, and only
      compensation for participation will remain. Data will be collected for three months in the
      post-intervention phase.

      The primary outcome of the study is medication adherence which will be measured using two
      different methods. The first method is through the use of eCaps (electronic caps). The second
      method is through a monthly randomized phone call during which the participant will be asked
      to perform a pill count of their medication.

      The secondary outcome of the study is blood pressure which will be measured using two
      different instruments . The first instrument will be the ambulatory blood pressure monitor
      (ABPM). The second instrument will be a home blood pressure monitor (HBPM) which researchers
      will provide to the participant to use for the duration of the study.

      All participants of the study will receive an unconditional payment each time they provide a
      blood pressure reading from the ABPM. Financial incentives (contingent to change in behavior
      -conditional to change in adherence). In addition to the unconditional payment, participants
      in the ICM and GCM treatment arms will receive a financial incentive that is conditional to
      medication adherence.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Investigator)
measure: Self Assessed Medication Adherence
time frame: Monthly over 8 months
description: Use self reported personal pill count to calculate the Medication Possession Ratio score, this ratio is explained in the protocol and can explain how multiple measurements will be aggregated to arrive at one reported value.
measure: Self Assessed Diastolic Blood pressure (mm Hg)
time frame: Monthly over 8 months
description: Self blood diastolic pressure reading with the HBPM device.
measure: Automatic measure of Medication Adherence
time frame: Daily over 8 months
description: Use the Research Electronic Data Capture (REDCap) system to gather a pill count to calculate the Medication Possession Ratio score.
measure: Self Assessed Systolic Blood pressure (mm Hg)
time frame: Monthly over 8 months
description: Self blood systolic pressure reading with the HBPM device.
measure: Automatic measure of Diastolic Blood pressure (mm Hg)
time frame: Three times over 8 months
description: Blood Diastolic pressure reading with the ABPM device.
measure: Automatic measure of Systolic Blood pressure (mm Hg)
time frame: Three times over 8 months
description: Blood Systolic pressure reading with the ABPM device.
arm group label: Group Contingency Management
arm group type: Active Comparator
description: During the intervention phase, the Group Contingency Management (GCM) arm will continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a home blood pressure monitoring reading using the HBPM. Participants in the GCM arm will receive a payment after each phone call, dependent on their medication adherence assessment. The GCM arm will also receive an additional payment based on their group's medication adherence.The intervention administered is the Financial Reward and Social Norms.
arm group label: Individual Contingency Management
arm group type: Active Comparator
description: During the intervention phase, those in the Individual Contingency Management (ICM) arm will also continue to take their hypertensive medication for the four-month period but will receive a payment after each phone call, dependent on their medication adherence assessment.The intervention administered is the Financial Reward.
arm group label: Control Arm
arm group type: Placebo Comparator
description: During the intervention phase, those in the control arm will be asked to continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a blood pressure reading using the HBPM. Those in the control arm will only be paid for their participation in the study regardless of medication adherence assessment.
intervention type: Behavioral
intervention name: Financial reward
description: In contingency management, financial rewards are contingent upon an individual changing behavior. In our study, financial incentives are contingent upon group behavioral changes.. In the intervention phase participants will be randomly assigned to one of the three treatment arms and they will receive the financial incentive that corresponds to their treatment arm. Data will be collected for four months and all participants will continue receiving a compensation for participation
arm group label: Group Contingency Management
arm group label: Individual Contingency Management
intervention type: Behavioral
intervention name: Social norms
description: To build social norms the study adds a group component to a contingency management model. In contingency management, financial rewards are contingent upon an individual changing behavior. Social norms are expected to emerge as a result of the designed group contingency management, monthly-facilitated meetings at a local clinic, and daily basis interaction through social media. The intervention will build social norms that improve medication adherence of each member of a group. A three-arm randomize trial is designed to test this hypothesis. Hypertensive patients will be randomly assigned to a group contingency management (GCM) arm, an individual contingency management (ICG) arm, or a control arm.
arm group label: Group Contingency Management
intervention type: Device
intervention name: Home Blood Pressure Monitoring
description: Participants will be reminded that they will receive and learn how to use a Home Blood Pressure Monitor (HBPM) device that participant will keep for the duration of the study
arm group label: Control Arm
arm group label: Group Contingency Management
arm group label: Individual Contingency Management
intervention type: Device
intervention name: Medication adherence assessment
description: Participants will be informed that they will receive and learn how to use eCap, a medication event monitoring system that participants will return after completing the study. The project nursing student will count the number of pills the participant currently has and make a record of it on the Data Collection form.The participant will provide the project nursing student with his/her antihypertension prescription records so that the dosage amount and number of pills can be recorded on the Data Collection form.
arm group label: Control Arm
arm group label: Group Contingency Management
arm group label: Individual Contingency Management
other name: eCap
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alejandro Arrieta, PhD
role: Principal Investigator
affiliation: Florida International University
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No