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/NCT06016101</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00948-37</org_study_id>
      <nct_id>NCT06016101</nct_id>
    </id_info>
    <brief_title>Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies</brief_title>
    <official_title>Usefulness of the Medissimo Nurse Application for Supporting Medication Compliance in Elderly People With Chronic Polypathologies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RIVAGES</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RIVAGES</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, the investigators are interested in the Medissimo nurse application, which is&#xD;
        a medication monitoring application for the elderly dedicated to self-employed nurses. The&#xD;
        aim is to estimate the consistency of the measure of medication compliance assessed by this&#xD;
        application with reference measures, as well as the user experience of healthcare&#xD;
        professionals with this application.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction :&#xD;
  &#xD;
        As people age, the number of chronic illnesses in the same person tends to increase. Poor&#xD;
        compliance with treatment or interrupted medication exposes patients to risks to their&#xD;
        health, and the consequences represent avoidable costs for the healthcare system. In&#xD;
        practice, however, it is not easy to measure compliance with medication. E-health devices&#xD;
        dedicated to taking medication represent a new way of measuring medication adherence, a&#xD;
        necessary step towards improving it.&#xD;
  &#xD;
        Objectives :&#xD;
  &#xD;
        Main: To assess the concordance of adherence measurement by the Medissimo nurse application&#xD;
        used in an existing e-Health device aimed at improving the dispensing and monitoring of&#xD;
        prescribed medication for people living at home, with reference measurements.Secondary: To&#xD;
        explore the user-experience of the healthcare professionals (pharmacists, nurses and GPs)&#xD;
        involved with two aspects: use of the application itself and interest in the reports&#xD;
        generated by this application.&#xD;
  &#xD;
        Methods :&#xD;
  &#xD;
        Methodological design: Cross-sectional observational study in routine care (RIPH3).&#xD;
  &#xD;
        Patients: The study will focus on one hundred patients aged over 65, who are already Medipac®&#xD;
        pillbox users and receive home nursing visits as part of their usual care. Each month, the&#xD;
        beneficiaries of the service receive weekly pillboxes prepared by the referring pharmacist,&#xD;
        and the homecare nurses are equipped with the Medissimo nurse smartphone application, which&#xD;
        can be used to record the quality of doses taken, any undesirable effects, reasons for not&#xD;
        taking the medication and dose adjustments. The system generates a monthly report summarising&#xD;
        this monitoring, which is shared with the referring pharmacist and sent to the GP. In this&#xD;
        way, the system produces a measure of medication compliance. To validate this measure, the&#xD;
        investigators will carry out two reference measures of compliance with medication for the&#xD;
        same patients: the Morisky questionnaire (completed by the home care nurse during a regular&#xD;
        visit) and the pill count by the referring pharmacist when the pillboxes are renewed. The&#xD;
        analysis will focus on the concordance between overall medication compliance measured by the&#xD;
        Medissimo nurse application and that given by reference measurements.&#xD;
  &#xD;
        Healthcare professionals: The study will also involve 60 healthcare professionals (20 nurses,&#xD;
        20 pharmacists, 20 GPs) affected by the application, in order to assess their user&#xD;
        experience. For nurses' use of the application, the investigators will use the System&#xD;
        Usability Scale (SUS) questionnaire in a telephone interview. To assess interest in the&#xD;
        monthly reports sent to these professionals, the investigators will use a Likert-type&#xD;
        questionnaire in a telephone interview.&#xD;
  &#xD;
        Future prospects:&#xD;
  &#xD;
        If the application's compliance measurements are consistent with the reference measurements,&#xD;
        the system could provide an additional means of supporting compliance with medication.&#xD;
        Finally, if the data on the user experience and the monthly reports drawn up by the&#xD;
        application are positive, it could represent a quick and easy way for professionals to&#xD;
        coordinate the management of patients followed at home.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Socio-demographic data (for all participants) Medical data</measure>
      <time_frame>about 3 months</time_frame>
      <description>Descriptive statistics on data (mean, standard deviation, median)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient analyses : Pill counting</measure>
      <time_frame>about 3 months</time_frame>
      <description>Blant and Altman diagram to estimate the agreement between the two measurements (pill count and missed doses): determine the difference between the measurements for each mode of observation. The mean difference between the two measurements will be used to determine the bias. We will also try to assess the precision, which estimates the dispersion of the absolute bias. Precision will be estimated by the 95% agreement limits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient analyses : Recording of omissions in the monthly compliance report of patients taking part in the study</measure>
      <time_frame>about 3 months</time_frame>
      <description>Blant and Altman diagram to estimate the agreement between the two measurements (pill count and missed doses): determine the difference between the measurements for each mode of observation. The mean difference between the two measurements will be used to determine the bias. We will also try to assess the precision, which estimates the dispersion of the absolute bias. Precision will be estimated by the 95% agreement limits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient analyses : Morisky questionnaire</measure>
      <time_frame>about 3 months</time_frame>
      <description>Cohen's Kappa test: used to measure Morisky's score, and to test the concordance between the good adherence/average adherence/low adherence classification and the classification from the Medissimo application. We set the threshold for Cohen's Kappa test at 0.80, which corresponds to very good agreement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of professionals : User experience analysis</measure>
      <time_frame>about 3 months</time_frame>
      <description>Qualitative analysis :&#xD;
  Evaluation of user experimentation using the SUS (Sytem usability scale) questionnaire. This is an easy-to-use Likert-type scale comprising 10 questions. The aim is to evaluate the point of view of the Medissimo nurse user, after having had the opportunity to use it. The questions offer quick answers, ranging from &quot;strongly disagree&quot; to &quot;strongly agree&quot;. The degree of acceptability, highlighted in the study by Bangor and al. (2009), is as follows:&#xD;
  Between 0 and 50: not acceptable&#xD;
  Between 50 and 60: Acceptability likely, but low&#xD;
  Between 60 and 70: Acceptability likely, high&#xD;
  Between 70 and 100: Acceptable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analysis of professionals : Analysis of healthcare professionals' assessments</measure>
      <time_frame>about 3 months</time_frame>
      <description>Qualitative analysis :&#xD;
  This is a &quot;likert&quot; type questionnaire designed by the investigator specifically for this study. This 12-item questionnaire will be used to obtain feedback from healthcare professionals on the monthly reports produced by the application for nurses. The questionnaire consists of :&#xD;
  10 closed questions&#xD;
  2 open questions with short answers</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Digital Application</condition>
    <condition>Elderly Person</condition>
    <condition>Chronic Disease</condition>
    <condition>Polypathology</condition>
    <condition>Medication Compliance</condition>
    <arm_group>
      <arm_group_label>100 Patients</arm_group_label>
      <description>Socio-demographic data (age, gender, lifestyle, medication management aids)&#xD;
  Medical data (number and type of medications)&#xD;
  Variables for calculating assessment criteria:&#xD;
  &lt; Pill count: this is a simple way of estimating compliance with medication. The pharmacist will calculate the pill count. The remaining pills (not taken by the patient) are brought to the pharmacist, who then calculates them. The pill count is not used as part of routine care for Medipac beneficiaries.&#xD;
  &lt; The Morisky adherence questionnaire is an 8-item hetero-questionnaire used to measure adherence to treatment. It will be carried out by the home care nurse as part of routine care. The scores can be interpreted as follows: ≥ 8: good adherence; 6 to 7: average adherence; &lt; 6: poor adherence.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)</arm_group_label>
      <description>Socio-demographic data (age, gender, profession)&#xD;
  Evaluation of the user experience using the SUS (Sytem usability scale) questionnaire. This is an easy-to-use Likert-type scale consisting of 10 questions. The aim is to assess the point of view of the person using the Medissimo nurse application, after having had the opportunity to use it. The questions offer quick answers, ranging from &quot;strongly disagree&quot; to &quot;strongly agree&quot;.&#xD;
  Assessment of the monthly reports produced by the application for nurses, GPs and pharmacists. Using a Likert-type questionnaire, they will be asked to describe their satisfaction, and the beneficial or negative aspects of this application in relation to patient monitoring. The questionnaire consists of 12 questions, 10 of which offer the following 5 responses: &quot;Strongly agree&quot;; &quot;Agree&quot;; &quot;Neither disagree nor agree&quot;; &quot;Disagree&quot;; &quot;Strongly disagree&quot;, and 2 short-answer, open-ended questions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>100 Patients</intervention_name>
      <description>For patients and professionals: retrieval of socio-demographic data&#xD;
  For patients :&#xD;
  Pill counting&#xD;
  Morisky questionnaire</description>
      <arm_group_label>100 Patients</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)</intervention_name>
      <description>For patients and professionals: retrieval of socio-demographic data&#xD;
  For healthcare professionals :&#xD;
  Evaluation of user experience&#xD;
  Evaluation of the report produced by the application</description>
      <arm_group_label>Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Medissimo will contact 100 pharmacies that use the Medipac® system to ask them to take part&#xD;
          in the study. The pharmacists to whom the study will be proposed will be selected from&#xD;
          users in the Paris region for reasons of geographical proximity.&#xD;
  &#xD;
          Patients will be selected from among Medipac® pillbox users dispensed by pharmacists who&#xD;
          agree to take part in the study. All patients of pharmacists who accept and receive home&#xD;
          visits by private nurses (beneficiaries of the Medissimo nurse application) will be&#xD;
          considered eligible. We expect to include 5 patients per pharmacist (i.e. a total of 100&#xD;
          patients). As far as the patients are concerned, their nurse will have to be informed of&#xD;
          the study, will give them the information letter and will have to ensure that they do not&#xD;
          object to taking part.&#xD;
  &#xD;
          The professionals (nurses, GPs and pharmacists) will be selected from Medissimo and chosen&#xD;
          at random. The study investigator will contact them to offer to participate and to seek&#xD;
          their consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patient inclusion criteria:&#xD;
  &#xD;
            -  People aged over 65 receiving more than 5 chronic medications&#xD;
  &#xD;
            -  Person agreeing to take part in the study&#xD;
  &#xD;
            -  Person living at home receiving home nursing care as part of routine care&#xD;
  &#xD;
            -  Person whose carer is already a user of the application under study&#xD;
  &#xD;
          Inclusion criteria for professionals:&#xD;
  &#xD;
            -  Home nurses who have been using the Medissimo nurse application for at least 1 month&#xD;
               and who agree to take part in the study or&#xD;
  &#xD;
            -  Private practitioners who agree to take part in the study or&#xD;
  &#xD;
            -  Pharmacists who have been using the Medissimo nurse service for at least 1 month and&#xD;
               who agree to take part in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patient exclusion criteria:&#xD;
  &#xD;
            -  Refusal to take part in the study&#xD;
  &#xD;
            -  Person in palliative care&#xD;
  &#xD;
            -  Person under protection, guardianship or curatorship&#xD;
  &#xD;
          Exclusion criteria for professionals:&#xD;
  &#xD;
          - Refusal to take part in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joël Belmin, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Association Rivages</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joël Belmin, Professor</last_name>
      <phone>+33149594565</phone>
      <email>j.belmin@aphp.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Compliance</keyword>
    <keyword>medication adherence</keyword>
    <keyword>electronic tool</keyword>
    <keyword>digital health</keyword>
    <keyword>e-health</keyword>
    <keyword>user's experience</keyword>
    <keyword>elderly</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06016101
  org study id: 2023-A00948-37
  nct id: NCT06016101
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, the investigators are interested in the Medissimo nurse application, which is
        a medication monitoring application for the elderly dedicated to self-employed nurses. The
        aim is to estimate the consistency of the measure of medication compliance assessed by this
        application with reference measures, as well as the user experience of healthcare
        professionals with this application.
  Introduction :
  
        As people age, the number of chronic illnesses in the same person tends to increase. Poor
        compliance with treatment or interrupted medication exposes patients to risks to their
        health, and the consequences represent avoidable costs for the healthcare system. In
        practice, however, it is not easy to measure compliance with medication. E-health devices
        dedicated to taking medication represent a new way of measuring medication adherence, a
        necessary step towards improving it.
  
        Objectives :
  
        Main: To assess the concordance of adherence measurement by the Medissimo nurse application
        used in an existing e-Health device aimed at improving the dispensing and monitoring of
        prescribed medication for people living at home, with reference measurements.Secondary: To
        explore the user-experience of the healthcare professionals (pharmacists, nurses and GPs)
        involved with two aspects: use of the application itself and interest in the reports
        generated by this application.
  
        Methods :
  
        Methodological design: Cross-sectional observational study in routine care (RIPH3).
  
        Patients: The study will focus on one hundred patients aged over 65, who are already Medipac®
        pillbox users and receive home nursing visits as part of their usual care. Each month, the
        beneficiaries of the service receive weekly pillboxes prepared by the referring pharmacist,
        and the homecare nurses are equipped with the Medissimo nurse smartphone application, which
        can be used to record the quality of doses taken, any undesirable effects, reasons for not
        taking the medication and dose adjustments. The system generates a monthly report summarising
        this monitoring, which is shared with the referring pharmacist and sent to the GP. In this
        way, the system produces a measure of medication compliance. To validate this measure, the
        investigators will carry out two reference measures of compliance with medication for the
        same patients: the Morisky questionnaire (completed by the home care nurse during a regular
        visit) and the pill count by the referring pharmacist when the pillboxes are renewed. The
        analysis will focus on the concordance between overall medication compliance measured by the
        Medissimo nurse application and that given by reference measurements.
  
        Healthcare professionals: The study will also involve 60 healthcare professionals (20 nurses,
        20 pharmacists, 20 GPs) affected by the application, in order to assess their user
        experience. For nurses' use of the application, the investigators will use the System
        Usability Scale (SUS) questionnaire in a telephone interview. To assess interest in the
        monthly reports sent to these professionals, the investigators will use a Likert-type
        questionnaire in a telephone interview.
  
        Future prospects:
  
        If the application's compliance measurements are consistent with the reference measurements,
        the system could provide an additional means of supporting compliance with medication.
        Finally, if the data on the user experience and the monthly reports drawn up by the
        application are positive, it could represent a quick and easy way for professionals to
        coordinate the management of patients followed at home.
  observational model: Other
  time perspective: Other
  measure: Socio-demographic data (for all participants) Medical data
  time frame: about 3 months
  description: Descriptive statistics on data (mean, standard deviation, median)
  measure: Patient analyses : Pill counting
  time frame: about 3 months
  description: Blant and Altman diagram to estimate the agreement between the two measurements (pill count and missed doses): determine the difference between the measurements for each mode of observation. The mean difference between the two measurements will be used to determine the bias. We will also try to assess the precision, which estimates the dispersion of the absolute bias. Precision will be estimated by the 95% agreement limits.
  measure: Patient analyses : Recording of omissions in the monthly compliance report of patients taking part in the study
  time frame: about 3 months
  description: Blant and Altman diagram to estimate the agreement between the two measurements (pill count and missed doses): determine the difference between the measurements for each mode of observation. The mean difference between the two measurements will be used to determine the bias. We will also try to assess the precision, which estimates the dispersion of the absolute bias. Precision will be estimated by the 95% agreement limits.
  measure: Patient analyses : Morisky questionnaire
  time frame: about 3 months
  description: Cohen's Kappa test: used to measure Morisky's score, and to test the concordance between the good adherence/average adherence/low adherence classification and the classification from the Medissimo application. We set the threshold for Cohen's Kappa test at 0.80, which corresponds to very good agreement.
  measure: Analysis of professionals : User experience analysis
  time frame: about 3 months
  description: Qualitative analysis :
  Evaluation of user experimentation using the SUS (Sytem usability scale) questionnaire. This is an easy-to-use Likert-type scale comprising 10 questions. The aim is to evaluate the point of view of the Medissimo nurse user, after having had the opportunity to use it. The questions offer quick answers, ranging from "strongly disagree" to "strongly agree". The degree of acceptability, highlighted in the study by Bangor and al. (2009), is as follows:
  Between 0 and 50: not acceptable
  Between 50 and 60: Acceptability likely, but low
  Between 60 and 70: Acceptability likely, high
  Between 70 and 100: Acceptable
  measure: Analysis of professionals : Analysis of healthcare professionals' assessments
  time frame: about 3 months
  description: Qualitative analysis :
  This is a "likert" type questionnaire designed by the investigator specifically for this study. This 12-item questionnaire will be used to obtain feedback from healthcare professionals on the monthly reports produced by the application for nurses. The questionnaire consists of :
  10 closed questions
  2 open questions with short answers
  arm group label: 100 Patients
  description: Socio-demographic data (age, gender, lifestyle, medication management aids)
  Medical data (number and type of medications)
  Variables for calculating assessment criteria:
  < Pill count: this is a simple way of estimating compliance with medication. The pharmacist will calculate the pill count. The remaining pills (not taken by the patient) are brought to the pharmacist, who then calculates them. The pill count is not used as part of routine care for Medipac beneficiaries.
  < The Morisky adherence questionnaire is an 8-item hetero-questionnaire used to measure adherence to treatment. It will be carried out by the home care nurse as part of routine care. The scores can be interpreted as follows: ≥ 8: good adherence; 6 to 7: average adherence; < 6: poor adherence.
  arm group label: Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)
  description: Socio-demographic data (age, gender, profession)
  Evaluation of the user experience using the SUS (Sytem usability scale) questionnaire. This is an easy-to-use Likert-type scale consisting of 10 questions. The aim is to assess the point of view of the person using the Medissimo nurse application, after having had the opportunity to use it. The questions offer quick answers, ranging from "strongly disagree" to "strongly agree".
  Assessment of the monthly reports produced by the application for nurses, GPs and pharmacists. Using a Likert-type questionnaire, they will be asked to describe their satisfaction, and the beneficial or negative aspects of this application in relation to patient monitoring. The questionnaire consists of 12 questions, 10 of which offer the following 5 responses: "Strongly agree"; "Agree"; "Neither disagree nor agree"; "Disagree"; "Strongly disagree", and 2 short-answer, open-ended questions.
  intervention type: Other
  intervention name: 100 Patients
  description: For patients and professionals: retrieval of socio-demographic data
  For patients :
  Pill counting
  Morisky questionnaire
  arm group label: 100 Patients
  intervention type: Other
  intervention name: Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)
  description: For patients and professionals: retrieval of socio-demographic data
  For healthcare professionals :
  Evaluation of user experience
  Evaluation of the report produced by the application
  arm group label: Healthcare professionals (20 doctors, 20 pharmacists and 20 nurses)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joël Belmin, Professor
  role: Principal Investigator
  affiliation: Association Rivages
  last name: Joël Belmin, Professor
  phone: +33149594565
  email: j.belmin@aphp.fr
  responsible party type: Sponsor
  mesh term: Chronic Disease
  sharing ipd: No