xml: <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/NCT06034301</url>
    </required_header>
    <id_info>
      <org_study_id>202306153</org_study_id>
      <nct_id>NCT06034301</nct_id>
    </id_info>
    <brief_title>Pill Bottle vs Reminder App</brief_title>
    <official_title>Feasibility of Interventions Impacting Medication Adherence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Washington University School of Medicine</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>
        Current medication adherence interventions are minimally effective, which results in higher&#xD;
        rates of morbidity and mortality for 45 million US adults who have hypertension and low&#xD;
        adherence. This feasibility randomized controlled trial seeks to understand the efficacy of&#xD;
        reminders and monitoring in the form of a mobile phone application vs usual care on&#xD;
        medication adherence as well as the feasibility of the intervention and study procedures.&#xD;
        This study will compare participants who use a mobile phone app that notifies them when to&#xD;
        take their medications (intervention group) to participants who do not get assigned the app&#xD;
        (control group) for 30 days. Medication adherence will be monitored using a Medication Event&#xD;
        Monitoring System (MEMS) cap. Both groups will also receive the usual care, which will&#xD;
        include giving participants a pamphlet about taking their medications. The long-term goal of&#xD;
        this work is to improve antihypertensive medication adherence and to decrease morbidity and&#xD;
        mortality. The objective of this application is to test the efficacy of the app based&#xD;
        reminders and feedback. The hypothesis driving this research is that the intervention will be&#xD;
        more effective than the usual care. The specific aims are as follows:&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Current medication adherence interventions are minimally effective, which results in higher&#xD;
        rates of morbidity and mortality for 45 million US adults who have hypertension and low&#xD;
        adherence. This feasibility randomized controlled trial seeks to understand the efficacy of&#xD;
        reminders and monitoring in the form of a mobile phone application vs usual care on&#xD;
        medication adherence as well as the feasibility of the intervention and study procedures.&#xD;
        This study will compare participants who use a mobile phone app that notifies them when to&#xD;
        take their medications (intervention group) to participants who do not get assigned the app&#xD;
        (control group) for 30 days. Participants will receive an electronic monitoring cap (i.e. a&#xD;
        Medication Event Monitoring System (MEMS) cap) to monitor when they take their&#xD;
        antihypertensive medications while they are in the study. Both groups will also receive the&#xD;
        usual care, which will include giving participants a pamphlet about taking their medications.&#xD;
        The long-term goal of this work is to improve antihypertensive medication adherence and to&#xD;
        decrease morbidity and mortality. The objective of this application is to test the efficacy&#xD;
        of the app based reminders and feedback. The hypothesis driving this research is that the&#xD;
        intervention will be more effective than the usual care. The specific aims are as follows:&#xD;
  &#xD;
        Aim 1. Compare the efficacy of the app based reminders and feedback with usual care for the&#xD;
        primary outcome of medication adherence in 40 adults with hypertension and low adherence.&#xD;
  &#xD;
        Aim 2. Conduct a robust process evaluation to guide intervention improvements, dissemination,&#xD;
        and implementation in a diverse sample.&#xD;
  &#xD;
        The hypothesis will be tested for two specific aims in 40 adults (20 control, 20&#xD;
        intervention) with hypertension and low adherence. For these aims, the study will be&#xD;
        conducted as a phase II single-blind, parallel-group, randomized controlled trial with&#xD;
        diverse adults with hypertension over 30 days. Participants will answer surveys about their&#xD;
        demographics, knowledge about hypertension, and their medication adherence. They will then be&#xD;
        randomized and either be given the standard of care or standard of care plus the intervention&#xD;
        (app-based reminders and feedback). The intervention includes a brief training session on&#xD;
        downloading and using the medication reminder app. Across arms, Participants will track their&#xD;
        medication adherence for 30 days using the MEMS cap. After the 30 days, participants will&#xD;
        take surveys about their adherence and knowledge about hypertension and have a brief exit&#xD;
        interview with a member of the research team to talk about their experience and debrief them&#xD;
        about the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Feasibility randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The recruitment material and informed consent will make it appear that the effectiveness between an electronic medication cap and a medication adherence app are being compared and that some participants will get the app while others will get the electronic medication bottle. The reality is that all participants will receive an electronic medication bottle.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Medication Event Monitoring System (MEMS) Cap</measure>
      <time_frame>30 days</time_frame>
      <description>The Medication Event Monitoring System (MEMS) measures medication adherence over 30 days at home. In this system, an electronic cap will be placed on a bottle assigned to the participant's antihypertensive medication and records each time the medication bottle is opened. All participants will use the electronic monitoring for one antihypertensive medication taken daily.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Exit interview</measure>
      <time_frame>30 days</time_frame>
      <description>In the exit interview, participants will be asked qualitative questions about their experiences in the study and using the MEMS cap and medication reminder app. This will support a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Hypertension</condition>
    <condition>Medication Adherence</condition>
    <arm_group>
      <arm_group_label>MEMS Cap Only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>If the participant is randomized to the control group, they will:&#xD;
  receive a brief education session and be handed a flyer about the importance of medication adherence&#xD;
  receive a MEMS cap and be given instructions on how to use it with their blood pressure medication</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Medication Reminder App + MEMS Cap</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intervention group that will be shown how to use the mobile phone medication reminder app and be given assistance downloading and setting it up on their personal phone.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Medication Reminder App</intervention_name>
      <description>If the participant is randomized to the intervention group, they will:&#xD;
  receive a brief education session and be handed a flyer about the importance of medication adherence.&#xD;
  get training on how to use the medication reminder app and participant will be given a user guide on how to use the app&#xD;
  demonstrate their understanding on an iPad using the teach back method&#xD;
  install and set up the medication reminder app on their phone&#xD;
  receive a MEMS cap and be given instructions on how to use it with their blood pressure medication. Study team members will use a participant ID to log into the MEMS cap application; no identifiable information will be entered.</description>
      <arm_group_label>Medication Reminder App + MEMS Cap</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  currently be prescribed an antihypertensive medication by their doctor&#xD;
  &#xD;
            -  have taken antihypertensive medication for the last year&#xD;
  &#xD;
            -  be willing to download and use a new app on their phone for the study&#xD;
  &#xD;
            -  score a 34 or lower on the Hill Bone compliance scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  need assistance taking their medications&#xD;
  &#xD;
            -  have a severe cognitive impairment&#xD;
  &#xD;
            -  have a severe visual impairment that prevents them from reading notifications on their&#xD;
               phone&#xD;
  &#xD;
            -  use a pillbox to take their medications&#xD;
  &#xD;
            -  do not use a smart phone or their smart phone does not meet the requirements for the&#xD;
               app to be downloaded&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jaclyn Schwartz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jaclyn Schwartz, PhD</last_name>
      <phone>(314)273-4398</phone>
      <email>jaclyns@wustl.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sami Tayeb, MA</last_name>
      <phone>(314)273-4437</phone>
      <email>samit@wustl.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Washington University in St. Louis</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sami Tayeb, MA</last_name>
        <phone>314-273-4437</phone>
        <email>samit@wustl.edu</email>
      </contact>
      <investigator>
        <last_name>Jaclyn Schwartz, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Ahmed I, Ahmad NS, Ali S, Ali S, George A, Saleem Danish H, Uppal E, Soo J, Mobasheri MH, King D, Cox B, Darzi A. Medication Adherence Apps: Review and Content Analysis. JMIR Mhealth Uhealth. 2018 Mar 16;6(3):e62. doi: 10.2196/mhealth.6432.</citation>
      <PMID>29549075</PMID>
    </reference>
    <reference>
      <citation>Aldeer M., Javanmard M., &amp; Martin R. P. (2018). A review of medication adherence monitoring technologies. Applied System Innovation, 1(2), 2. https://doi: 10.3390/asi1020014.</citation>
    </reference>
    <reference>
      <citation>Morrissey EC, Casey M, Glynn LG, Walsh JC, Molloy GJ. Smartphone apps for improving medication adherence in hypertension: patients' perspectives. Patient Prefer Adherence. 2018 May 14;12:813-822. doi: 10.2147/PPA.S145647. eCollection 2018.</citation>
      <PMID>29785096</PMID>
    </reference>
    <reference>
      <citation>Santo K, Chow CK, Thiagalingam A, Rogers K, Chalmers J, Redfern J. MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol. BMJ Open. 2017 Oct 8;7(10):e017540. doi: 10.1136/bmjopen-2017-017540.</citation>
      <PMID>28993388</PMID>
    </reference>
    <reference>
      <citation>Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.</citation>
      <PMID>31167489</PMID>
    </reference>
    <reference>
      <citation>Santo K, Singleton A, Rogers K, Thiagalingam A, Chalmers J, Chow CK, Redfern J. Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial. Heart. 2019 Feb;105(4):323-329. doi: 10.1136/heartjnl-2018-313479. Epub 2018 Aug 27.</citation>
      <PMID>30150326</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Occupational Therapy</keyword>
    <keyword>Medication Management</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>Yes</sharing_ipd>
      <ipd_description>Individual participant data that underlie the results reported in any publications, after deidentification (text, tables, figures, and appendices).</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal.</ipd_access_criteria>
      <ipd_url>https://beckerdms.wustl.edu/</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034301
  org study id: 202306153
  nct id: NCT06034301
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Current medication adherence interventions are minimally effective, which results in higher
        rates of morbidity and mortality for 45 million US adults who have hypertension and low
        adherence. This feasibility randomized controlled trial seeks to understand the efficacy of
        reminders and monitoring in the form of a mobile phone application vs usual care on
        medication adherence as well as the feasibility of the intervention and study procedures.
        This study will compare participants who use a mobile phone app that notifies them when to
        take their medications (intervention group) to participants who do not get assigned the app
        (control group) for 30 days. Medication adherence will be monitored using a Medication Event
        Monitoring System (MEMS) cap. Both groups will also receive the usual care, which will
        include giving participants a pamphlet about taking their medications. The long-term goal of
        this work is to improve antihypertensive medication adherence and to decrease morbidity and
        mortality. The objective of this application is to test the efficacy of the app based
        reminders and feedback. The hypothesis driving this research is that the intervention will be
        more effective than the usual care. The specific aims are as follows:
  Current medication adherence interventions are minimally effective, which results in higher
        rates of morbidity and mortality for 45 million US adults who have hypertension and low
        adherence. This feasibility randomized controlled trial seeks to understand the efficacy of
        reminders and monitoring in the form of a mobile phone application vs usual care on
        medication adherence as well as the feasibility of the intervention and study procedures.
        This study will compare participants who use a mobile phone app that notifies them when to
        take their medications (intervention group) to participants who do not get assigned the app
        (control group) for 30 days. Participants will receive an electronic monitoring cap (i.e. a
        Medication Event Monitoring System (MEMS) cap) to monitor when they take their
        antihypertensive medications while they are in the study. Both groups will also receive the
        usual care, which will include giving participants a pamphlet about taking their medications.
        The long-term goal of this work is to improve antihypertensive medication adherence and to
        decrease morbidity and mortality. The objective of this application is to test the efficacy
        of the app based reminders and feedback. The hypothesis driving this research is that the
        intervention will be more effective than the usual care. The specific aims are as follows:
  
        Aim 1. Compare the efficacy of the app based reminders and feedback with usual care for the
        primary outcome of medication adherence in 40 adults with hypertension and low adherence.
  
        Aim 2. Conduct a robust process evaluation to guide intervention improvements, dissemination,
        and implementation in a diverse sample.
  
        The hypothesis will be tested for two specific aims in 40 adults (20 control, 20
        intervention) with hypertension and low adherence. For these aims, the study will be
        conducted as a phase II single-blind, parallel-group, randomized controlled trial with
        diverse adults with hypertension over 30 days. Participants will answer surveys about their
        demographics, knowledge about hypertension, and their medication adherence. They will then be
        randomized and either be given the standard of care or standard of care plus the intervention
        (app-based reminders and feedback). The intervention includes a brief training session on
        downloading and using the medication reminder app. Across arms, Participants will track their
        medication adherence for 30 days using the MEMS cap. After the 30 days, participants will
        take surveys about their adherence and knowledge about hypertension and have a brief exit
        interview with a member of the research team to talk about their experience and debrief them
        about the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Feasibility randomized controlled trial
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: The recruitment material and informed consent will make it appear that the effectiveness between an electronic medication cap and a medication adherence app are being compared and that some participants will get the app while others will get the electronic medication bottle. The reality is that all participants will receive an electronic medication bottle.
  measure: Medication Event Monitoring System (MEMS) Cap
  time frame: 30 days
  description: The Medication Event Monitoring System (MEMS) measures medication adherence over 30 days at home. In this system, an electronic cap will be placed on a bottle assigned to the participant's antihypertensive medication and records each time the medication bottle is opened. All participants will use the electronic monitoring for one antihypertensive medication taken daily.
  measure: Exit interview
  time frame: 30 days
  description: In the exit interview, participants will be asked qualitative questions about their experiences in the study and using the MEMS cap and medication reminder app. This will support a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
  arm group label: MEMS Cap Only
  arm group type: No Intervention
  description: If the participant is randomized to the control group, they will:
  receive a brief education session and be handed a flyer about the importance of medication adherence
  receive a MEMS cap and be given instructions on how to use it with their blood pressure medication
  arm group label: Medication Reminder App + MEMS Cap
  arm group type: Active Comparator
  description: Intervention group that will be shown how to use the mobile phone medication reminder app and be given assistance downloading and setting it up on their personal phone.
  intervention type: Device
  intervention name: Medication Reminder App
  description: If the participant is randomized to the intervention group, they will:
  receive a brief education session and be handed a flyer about the importance of medication adherence.
  get training on how to use the medication reminder app and participant will be given a user guide on how to use the app
  demonstrate their understanding on an iPad using the teach back method
  install and set up the medication reminder app on their phone
  receive a MEMS cap and be given instructions on how to use it with their blood pressure medication. Study team members will use a participant ID to log into the MEMS cap application; no identifiable information will be entered.
  arm group label: Medication Reminder App + MEMS Cap
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jaclyn Schwartz, PhD
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Jaclyn Schwartz, PhD
  phone: (314)273-4398
  email: jaclyns@wustl.edu
  last name: Sami Tayeb, MA
  phone: (314)273-4437
  email: samit@wustl.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Ahmed I, Ahmad NS, Ali S, Ali S, George A, Saleem Danish H, Uppal E, Soo J, Mobasheri MH, King D, Cox B, Darzi A. Medication Adherence Apps: Review and Content Analysis. JMIR Mhealth Uhealth. 2018 Mar 16;6(3):e62. doi: 10.2196/mhealth.6432.
  PMID: 29549075
  citation: Aldeer M., Javanmard M., & Martin R. P. (2018). A review of medication adherence monitoring technologies. Applied System Innovation, 1(2), 2. https://doi: 10.3390/asi1020014.
  citation: Morrissey EC, Casey M, Glynn LG, Walsh JC, Molloy GJ. Smartphone apps for improving medication adherence in hypertension: patients' perspectives. Patient Prefer Adherence. 2018 May 14;12:813-822. doi: 10.2147/PPA.S145647. eCollection 2018.
  PMID: 29785096
  citation: Santo K, Chow CK, Thiagalingam A, Rogers K, Chalmers J, Redfern J. MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol. BMJ Open. 2017 Oct 8;7(10):e017540. doi: 10.1136/bmjopen-2017-017540.
  PMID: 28993388
  citation: Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.
  PMID: 31167489
  citation: Santo K, Singleton A, Rogers K, Thiagalingam A, Chalmers J, Chow CK, Redfern J. Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial. Heart. 2019 Feb;105(4):323-329. doi: 10.1136/heartjnl-2018-313479. Epub 2018 Aug 27.
  PMID: 30150326
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: Yes
  ipd description: Individual participant data that underlie the results reported in any publications, after deidentification (text, tables, figures, and appendices).
  ipd info type: Study Protocol
  ipd time frame: Beginning 9 months and ending 36 months following article publication.
  ipd access criteria: Researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal.
  ipd url: https://beckerdms.wustl.edu/