<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/NCT03775044</url>
  </required_header>
  <id_info>
    <org_study_id>1R44MH116765-01</org_study_id>
    <nct_id>NCT03775044</nct_id>
  </id_info>
  <brief_title>Assessment of Medherent Medication Management Device and Adherence Platform</brief_title>
  <official_title>Assessment of Medherent Medication Management Device and Adherence Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Terrapin Pharmacy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Terrapin Pharmacy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study uses a stepped wedge designs to estimate the effect of using the Medherent&#xD;
      Medication Management Device on medication adherence for a population of 150 individuals who&#xD;
      are diagnosed with serious mental illness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals suffering from Serious Mental Illnesses (SMI) such as schizophrenia, bipolar&#xD;
      disorder or depressive disorders are at risk for serious adverse psychiatric, other health,&#xD;
      and social outcomes. Essential to controlling chronic psychiatric and health disorders is&#xD;
      adherence to medications that are prescribed to address the symptoms and causes of these&#xD;
      health conditions. Medication adherence is particularly challenging for those with SMI. Good&#xD;
      adherence is defined as 80% or more of medication taken, whereas the average patient with&#xD;
      schizophrenia or bipolar disorder takes 50-70% of prescribed medications. For individuals&#xD;
      with SMI, important barriers to adherence include cognitive impairments and lack of illness&#xD;
      insight, meaning that they are not aware of the symptoms and consequences of their illness.&#xD;
      Inquiries about drug intake by psychiatrists, relatives, or others has been linked to greater&#xD;
      adherence. Positive relationships with physicians, psychiatrists and their staff have been&#xD;
      found to be significant predictors of good adherence in SMI patients, while difficulties in&#xD;
      building a therapeutic alliance and poor clinical-patient relationship are significant&#xD;
      predictors of nonadherence. Failure to recognize nonadherence may prompt physicians to&#xD;
      misattribute poor outcomes to treatment failure, leading to inappropriate dosage increases or&#xD;
      unnecessary medication switches. Moreover, non- adherence in SMI patients is associated with&#xD;
      greater economic and social burden, due to higher hospitalization rates, longer hospital&#xD;
      stays, more emergency room and emergency psychiatric visits, greater risk of suicide and&#xD;
      violence towards others, and higher rates of deleterious psychotic relapses.&#xD;
&#xD;
      The Medherent© Medication Management Device (MMD) is a tool developed by Terrapin Pharmacy to&#xD;
      improve medication adherence through the integration of medication dispensing and prompts to&#xD;
      consumers to take medications, with real-time electronic feedback to care managers about&#xD;
      consumers' adherence behaviors and daily health status. This MMD builds on adherence&#xD;
      interventions proven effective in SMI patients and enables care managers to expand the number&#xD;
      of individuals that they can care for effectively.&#xD;
&#xD;
      This study uses a stepped-wedge design with 150 individuals across all study sites and&#xD;
      approximately 150 individuals to answer the following aims:&#xD;
&#xD;
        1. Measure the effect of the Medherent platform and interventions on adherence and&#xD;
           medication use.&#xD;
&#xD;
             1. Measure change in adherence by triangulating self-report data, clinician&#xD;
                observation, biological measures, chart reviews and clinical outcomes before and&#xD;
                after exposure to the Medherent intervention. Medherent device data will also be&#xD;
                used to measure the consumer levels of adherence to medications.&#xD;
&#xD;
             2. Document pharmacy interaction issues (e.g. arranging refill times, responsiveness&#xD;
                to prescription changes), device fail rate, and remaining user interface issues&#xD;
                (e.g. acceptability of adherence prompts, operating system issues).&#xD;
&#xD;
        2. Measure the effect of Medherent use on clinical outcomes and health service costs.&#xD;
&#xD;
             1. Change in clinical relationships, attitudes about medications, and acute care&#xD;
                service use (e.g. hospitalizations and emergency department visits) will be&#xD;
                measured by consumer interviews, chart reviews, Medherent dispensing data, and&#xD;
                claims data (Medicaid)&#xD;
&#xD;
             2. Using Medicaid data, pharmacy data, and agency clinical data we will develop a cost&#xD;
                model for Medherent users before and after enrollment and develop a matched&#xD;
                comparison group using other Maryland Medicaid recipients who have not been&#xD;
                enrolled in the Medherent treatment arm to measure changes in health service&#xD;
                utilization and the corresponding costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study is a stepped wedge design where all individuals receive the intervention but at different time points after enrollment in the study. Each person will have two observations before the intervention and three observations after the intervention. Health service use data will be collected for two years prior to enrollment and two years after enrollment.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking is possible for this study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Brief Evaluation of Medication Influences and Beliefs (BEMIB) Adherence Measure</measure>
    <time_frame>Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)</time_frame>
    <description>Brief Evaluation of Medication Influences and Beliefs (BEMIB) is an 8-item scale. Total scores range from 0 to 32 with higher scores indicating more negative beliefs about medications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Voils two-part measure of medication nonadherence</measure>
    <time_frame>Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)</time_frame>
    <description>Measure of extent of non adherence and reasons for non-adherence The extent of non-adherence scale averages scores over the 3 items and range from 1-5. The measure is continuous with higher scores indicating higher adherence. The reasons for non adherence scale is comprised of 24 reasons for non adherence and are scored individually from 1 to 5 with higher scores indicating more reasons for non adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Medication Records</measure>
    <time_frame>Change between weekly adherence from enrollment/baseline compared with weekly adherence for the year after receiving the Medherent Machine</time_frame>
    <description>Chart reviews for medication dispensing records and device dispensing data. Data will be combined to create a variable of medication taking behaviors. If an individual had a recorded dose received/dispensed they will be considered to have taken the dose if a dose was not received/dispensed they will be considered to have not taken a dose. Above 80% doses per week will be considered high adherence, 70-79% medium adherence and below 70% low adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chart review of clinical records for change in level of adherence support</measure>
    <time_frame>Change level of adherence support from enrollment/baseline compared to adherence support for the year after receiving the Medherent Machine (e.g. Treatment)</time_frame>
    <description>Level of staff medication support including categories. High Support = Mandatory daily supervision, Medium Support = pill count, low support = self-monitoring of medications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacy interaction outcomes: Refill Times</measure>
    <time_frame>Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)</time_frame>
    <description>Counts of days with out prescribed medication including days missed due to missed refills or gaps between receipt of prescription changes at the pharmacy till medication is refilled.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacy interaction outcomes: Medherent device fail/error rate</measure>
    <time_frame>Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)</time_frame>
    <description>Counts of device failures or user interface issues that cause a missed dose. Counts will be of missed doses per installed device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychiatric Acute Events</measure>
    <time_frame>Measured from two years prior to Medherent device installation through 1 year after device installation.</time_frame>
    <description>Record of psychiatric acute events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of Services</measure>
    <time_frame>Measured from two years prior to Medherent device installation through 1 year after device installation.</time_frame>
    <description>Medicaid and mental health agency costs data for calculating the cost of service.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Mental Health Disorder</condition>
  <condition>Medication Adherence</condition>
  <arm_group>
    <arm_group_label>Experimental: Medherent Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants get the Medherent device. There is only one arm to this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medherent Device</intervention_name>
    <description>The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.</description>
    <arm_group_label>Experimental: Medherent Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently be a client of a participating community mental health agency&#xD;
&#xD;
          -  Have a diagnoses mental illness&#xD;
&#xD;
          -  Currently be prescribed a psychotropic medication for the purpose of treatment a&#xD;
             mental illness&#xD;
&#xD;
          -  Be able to consent to participants in the study&#xD;
&#xD;
          -  Be over 18 years old and under 80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years old.&#xD;
&#xD;
          -  Over 80 years old.&#xD;
&#xD;
          -  Unable to consent to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Feldman, JD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Terrapin Pharmacy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Terrapin Pharmacy</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.terrapinpharmacy.com/medherent</url>
    <description>Medherent website</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>October 21, 2022</last_update_submitted>
  <last_update_submitted_qc>October 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Terrapin Pharmacy</investigator_affiliation>
    <investigator_full_name>Joel F. Feldman</investigator_full_name>
    <investigator_title>President</investigator_title>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>Mental Health Issue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De identified participant data for all primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Four years after the completion of the study.</ipd_time_frame>
    <ipd_access_criteria>We will make the data and associated documentation available to investigators who are working under an institution with a Federal Wide Assurance (FWA) and who agree to a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) appropriate Intuitional Review Board approval for data use; (3) a commitment to securing the data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed.</ipd_access_criteria>
  </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/NCT03775044
org study id: 1R44MH116765-01
nct id: NCT03775044
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study uses a stepped wedge designs to estimate the effect of using the Medherent
      Medication Management Device on medication adherence for a population of 150 individuals who
      are diagnosed with serious mental illness.
Individuals suffering from Serious Mental Illnesses (SMI) such as schizophrenia, bipolar
      disorder or depressive disorders are at risk for serious adverse psychiatric, other health,
      and social outcomes. Essential to controlling chronic psychiatric and health disorders is
      adherence to medications that are prescribed to address the symptoms and causes of these
      health conditions. Medication adherence is particularly challenging for those with SMI. Good
      adherence is defined as 80% or more of medication taken, whereas the average patient with
      schizophrenia or bipolar disorder takes 50-70% of prescribed medications. For individuals
      with SMI, important barriers to adherence include cognitive impairments and lack of illness
      insight, meaning that they are not aware of the symptoms and consequences of their illness.
      Inquiries about drug intake by psychiatrists, relatives, or others has been linked to greater
      adherence. Positive relationships with physicians, psychiatrists and their staff have been
      found to be significant predictors of good adherence in SMI patients, while difficulties in
      building a therapeutic alliance and poor clinical-patient relationship are significant
      predictors of nonadherence. Failure to recognize nonadherence may prompt physicians to
      misattribute poor outcomes to treatment failure, leading to inappropriate dosage increases or
      unnecessary medication switches. Moreover, non- adherence in SMI patients is associated with
      greater economic and social burden, due to higher hospitalization rates, longer hospital
      stays, more emergency room and emergency psychiatric visits, greater risk of suicide and
      violence towards others, and higher rates of deleterious psychotic relapses.

      The Medherent© Medication Management Device (MMD) is a tool developed by Terrapin Pharmacy to
      improve medication adherence through the integration of medication dispensing and prompts to
      consumers to take medications, with real-time electronic feedback to care managers about
      consumers' adherence behaviors and daily health status. This MMD builds on adherence
      interventions proven effective in SMI patients and enables care managers to expand the number
      of individuals that they can care for effectively.

      This study uses a stepped-wedge design with 150 individuals across all study sites and
      approximately 150 individuals to answer the following aims:

        1. Measure the effect of the Medherent platform and interventions on adherence and
           medication use.

             1. Measure change in adherence by triangulating self-report data, clinician
                observation, biological measures, chart reviews and clinical outcomes before and
                after exposure to the Medherent intervention. Medherent device data will also be
                used to measure the consumer levels of adherence to medications.

             2. Document pharmacy interaction issues (e.g. arranging refill times, responsiveness
                to prescription changes), device fail rate, and remaining user interface issues
                (e.g. acceptability of adherence prompts, operating system issues).

        2. Measure the effect of Medherent use on clinical outcomes and health service costs.

             1. Change in clinical relationships, attitudes about medications, and acute care
                service use (e.g. hospitalizations and emergency department visits) will be
                measured by consumer interviews, chart reviews, Medherent dispensing data, and
                claims data (Medicaid)

             2. Using Medicaid data, pharmacy data, and agency clinical data we will develop a cost
                model for Medherent users before and after enrollment and develop a matched
                comparison group using other Maryland Medicaid recipients who have not been
                enrolled in the Medherent treatment arm to measure changes in health service
                utilization and the corresponding costs.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study is a stepped wedge design where all individuals receive the intervention but at different time points after enrollment in the study. Each person will have two observations before the intervention and three observations after the intervention. Health service use data will be collected for two years prior to enrollment and two years after enrollment.
primary purpose: Health Services Research
masking: None (Open Label)
masking description: No masking is possible for this study.
measure: Change in Brief Evaluation of Medication Influences and Beliefs (BEMIB) Adherence Measure
time frame: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)
description: Brief Evaluation of Medication Influences and Beliefs (BEMIB) is an 8-item scale. Total scores range from 0 to 32 with higher scores indicating more negative beliefs about medications.
measure: Voils two-part measure of medication nonadherence
time frame: Change between enrollment/baseline and follow up measures (1 month, 6 month, 12 month)
description: Measure of extent of non adherence and reasons for non-adherence The extent of non-adherence scale averages scores over the 3 items and range from 1-5. The measure is continuous with higher scores indicating higher adherence. The reasons for non adherence scale is comprised of 24 reasons for non adherence and are scored individually from 1 to 5 with higher scores indicating more reasons for non adherence.
measure: Change in Medication Records
time frame: Change between weekly adherence from enrollment/baseline compared with weekly adherence for the year after receiving the Medherent Machine
description: Chart reviews for medication dispensing records and device dispensing data. Data will be combined to create a variable of medication taking behaviors. If an individual had a recorded dose received/dispensed they will be considered to have taken the dose if a dose was not received/dispensed they will be considered to have not taken a dose. Above 80% doses per week will be considered high adherence, 70-79% medium adherence and below 70% low adherence.
measure: Chart review of clinical records for change in level of adherence support
time frame: Change level of adherence support from enrollment/baseline compared to adherence support for the year after receiving the Medherent Machine (e.g. Treatment)
description: Level of staff medication support including categories. High Support = Mandatory daily supervision, Medium Support = pill count, low support = self-monitoring of medications
measure: Pharmacy interaction outcomes: Refill Times
time frame: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)
description: Counts of days with out prescribed medication including days missed due to missed refills or gaps between receipt of prescription changes at the pharmacy till medication is refilled.
measure: Pharmacy interaction outcomes: Medherent device fail/error rate
time frame: Data will be measured continuously for 1 year after receiving the Medherent Machine (e.g. Treatment)
description: Counts of device failures or user interface issues that cause a missed dose. Counts will be of missed doses per installed device
measure: Psychiatric Acute Events
time frame: Measured from two years prior to Medherent device installation through 1 year after device installation.
description: Record of psychiatric acute events
measure: Costs of Services
time frame: Measured from two years prior to Medherent device installation through 1 year after device installation.
description: Medicaid and mental health agency costs data for calculating the cost of service.
arm group label: Experimental: Medherent Device
arm group type: Experimental
description: All participants get the Medherent device. There is only one arm to this study.
intervention type: Device
intervention name: Medherent Device
description: The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.
arm group label: Experimental: Medherent Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joel Feldman, JD
role: Principal Investigator
affiliation: Terrapin Pharmacy
facility: 
country: United States
url: http://www.terrapinpharmacy.com/medherent
description: Medherent website
responsible party type: Principal Investigator
investigator affiliation: Terrapin Pharmacy
investigator full name: Joel F. Feldman
investigator title: President
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: De identified participant data for all primary and secondary outcome measures will be made available.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Four years after the completion of the study.
ipd access criteria: We will make the data and associated documentation available to investigators who are working under an institution with a Federal Wide Assurance (FWA) and who agree to a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) appropriate Intuitional Review Board approval for data use; (3) a commitment to securing the data using appropriate computer technology; and (4) a commitment to destroying or returning the data after analyses are completed.