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/NCT06004700</url>
    </required_header>
    <id_info>
      <org_study_id>2021P000790</org_study_id>
      <nct_id>NCT06004700</nct_id>
    </id_info>
    <brief_title>Improving Virtual Care of Arthritis: Integrating a Smartphone App Into the EHR for Improved Timeliness of Visits</brief_title>
    <official_title>Improving Virtual Care of Arthritis: Integrating a Smartphone App Into the EHR for Improved Timeliness of Visits (An Electronic Health Record Integrated Application for Psoriatic Arthritis Patient Reported Outcomes)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Janssen Scientific Affairs, LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Brigham and Women's Hospital</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The overall objective of this proposal is to test version 3.0 of the Arthritis smartphone app&#xD;
        in a 12-month interrupted time series analysis (ITSA) design which will allow us to observe&#xD;
        possible differences in visit frequency between the pre-and post-intervention periods as well&#xD;
        as between the concurrent control group and those who receive the app. Our central hypothesis&#xD;
        is that introduction of the app will reduce visit numbers per month in the group receiving&#xD;
        the app, compared with a concurrent control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim 1: To integrate an app for PsA into the EHR. In current work, user-centered design helped&#xD;
        develop an EHR integrated PRO-based app for RA. The roll out of the app has been successful&#xD;
        and the investigators now want to expand to focus on integration of a similar app for PsA.&#xD;
        The app will use similar PROs, adding in a patient global VAS, as well as a brief psoriasis&#xD;
        symptom checklist. The PROMIS Function Short Form, PROMIS Fatigue Short Form, PROMIS Pain&#xD;
        Short Form, and the PsAID-12 will be assessed. As well, the Q&amp;A function will be modified to&#xD;
        focus on PsA, allowing one to monitor symptom changes for patients using various PsA&#xD;
        treatments, focusing on guselkumab, infliximab, golimumab, and ustekinumab. Aim 1 is required&#xD;
        for the app testing in Aim 2.&#xD;
  &#xD;
        Aim 2: To conduct a single arm interrupted time series of the EHR-integrated PRO app for PsA&#xD;
        to assess whether it improves the timeliness of care. After integrating the app into the EHR,&#xD;
        the investigators will recruit 100 patients who use one of the following agents: guselkumab,&#xD;
        infliximab, golimumab, or ustekinumab. The goal will be to determine whether the app improves&#xD;
        visit timeliness. Timeliness will be defined as an increase in the percent of visits with&#xD;
        therapeutic changes over a 9-month trial period. A secondary outcome will assess PROs and&#xD;
        visit satisfaction. The app allows patients to remotely transmit PRO data to their care team.&#xD;
        Patients with very active disease between visits may consider a visit earlier than scheduled.&#xD;
        The investigators hypothesize that during the intervention period with app use, patients will&#xD;
        experience improved timeliness of PsA care when compared with the 9 months prior to the app&#xD;
        use, while maintaining patient-reported clinical outcomes.&#xD;
  &#xD;
        Data collection will occur via three methods. First, RA/PsA patients will provide answers to&#xD;
        the survey questions through the app on their smartphones or tablets and the ePRO data can be&#xD;
        viewed in an administrative dashboard. Second, the app will push an in-basket message to&#xD;
        rheumatologists letting them know 1 week before a patient visit that there are ePRO data in&#xD;
        Epic to be viewed. If symptoms reach a threshold suggesting poor disease control, then prior&#xD;
        to 1 week before the visit the app will send an in-basket message to the rheumatologists&#xD;
        letting them know to review patient data to consider an earlier visit. On the other hand, if&#xD;
        the ePRO data suggests stable symptoms, the app will push an in-basket message to the&#xD;
        rheumatologist 1 week before the next patient visit suggesting that the rheumatologist could&#xD;
        consider delaying the visit. The rheumatologist can respond as they see fit or not at all.&#xD;
        The last data collection will occur at the end of study when a satisfaction survey will be&#xD;
        completed through REDcap electronic consent.&#xD;
  &#xD;
        Analysis: The investigators anticipate near complete data, based on our prior studies.&#xD;
        However, the investigators will impute missing values using standard imputation methods.&#xD;
        Baseline characteristics of enrolled patients will be examined, assessing how well the&#xD;
        recruited patients reflect a typical PsA population. The investigators will then examine the&#xD;
        distribution of the visit timeliness (primary outcome) across the two time periods (pre and&#xD;
        post app). Monthly percentage of visits that qualify as timely will be estimated across the&#xD;
        study population. This allows us to assess the slopes during the two time periods. The&#xD;
        investigators hypothesize improved timeliness of visits in the 9 months after starting to use&#xD;
        the app compared with the pre-app 9 months. Thus, the primary analysis is a comparison of&#xD;
        slopes. With respect to the secondary outcomes, the investigators will calculate the change&#xD;
        from baseline to 9 months for each of the PROs. The distribution of PROs is typically normal.&#xD;
        The investigators will compare baseline to ending values for each PRO using an ANCOVA. with&#xD;
        an indicator term for rheumatologist. The investigators hypothesize that during this 9-month&#xD;
        study the change in PROs will be within the minimally clinically important difference (i.e.,&#xD;
        no change).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>A matched control group will be enrolled from medical records. The data analyst will be blinded to the treatment assignment (i.e., app intervention or matched controls)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Visit Frequency</measure>
      <time_frame>12 Months</time_frame>
      <description>The differences in visit frequency, between the pre-and post-intervention periods and between the concurrent control group and those who receive the app</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Function short form</measure>
      <time_frame>12 Months</time_frame>
      <description>Each short form will be rotated and asked twice during an 8-day cycle.&#xD;
  PROMIS is scored from 0-100. For the PROMIS Function, a higher score is better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form</measure>
      <time_frame>12 Months</time_frame>
      <description>Each short form will be rotated and asked twice during an 8-day cycle.&#xD;
  PROMIS is scored from 0-100. For the PROMIS Fatigue, a lower score is better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Pain short form</measure>
      <time_frame>12 Months</time_frame>
      <description>Each short form will be rotated and asked twice during an 8-day cycle.&#xD;
  PROMIS is scored from 0-100. For the PROMIS Pain, a lower score is better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psoriatic Arthritis Impact of Disease 12-item questionnaire (PsAID-12) for Clinical Practice</measure>
      <time_frame>12 Months</time_frame>
      <description>Each short form will be rotated and asked twice during an 8-day cycle.&#xD;
  The PsAID is calculated based on 12 Numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. The total is divided by 20. Thus, the range of the final PsAID value is 0-10 where higher figures indicate worse status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Standardized questionnaires for Arthritis Disease Activity</measure>
      <time_frame>12 Months</time_frame>
      <description>Each short form will be rotated and asked twice during an 8-day cycle.&#xD;
  Questions include:&#xD;
  i. How active is your arthritis today with respect to joint tenderness and swelling? ii. How severe is your arthritis pain today? iii. How would you describe your general health today? iv. Did you experience joint (hand) stiffness on awaking yesterday morning? If yes, how long was this stiffness?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with the App (patient and physician)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Patient Satisfaction with the App Physician Satisfaction with the App</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Arthritis</condition>
    <condition>Psoriatic Arthritis</condition>
    <arm_group>
      <arm_group_label>Mobile Application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This arm of the study will contain half the study population after randomization. The participants in this arm will receive the EHR integrated app and follow a 12-month interrupted time series analysis (ITSA) design.&#xD;
  n = 200</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This arm of the study will contain half the study population after randomization. The participants in this arm will be from the same rheumatologists as the experimental participants and will be used as concurrent controls by accessing their data on visits from the EHR during the same time period.&#xD;
  n = 200</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mobile Application</intervention_name>
      <description>The current app contains a disease activity questionnaire, a mood scale, a sleep scale, a pain scale, and a functional status scale. The app triggers a brief set of questions each day and allows patients to answer them within 24 hours.</description>
      <arm_group_label>Mobile Application</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be diagnosed with PsA by a board-certified rheumatologist and been seen at least twice&#xD;
               in the prior year&#xD;
  &#xD;
            -  Own a smartphone with either an Android or iPhone operating system&#xD;
  &#xD;
            -  Be at least 18 years old&#xD;
  &#xD;
            -  Be English-speaking&#xD;
  &#xD;
            -  Using guselkumab, infliximab, golimumab or ustekinumab&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not plan on receiving follow-up care at the Brigham and Women's&#xD;
               Arthritis Center will be excluded.&#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_contact>
      <last_name>Jacklyn Stratton</last_name>
      <phone>617-525-8784</phone>
      <email>jstratton1@bwh.harvard.edu</email>
    </overall_contact>
    <reference>
      <citation>Battafarano DF, Ditmyer M, Bolster MB, Fitzgerald JD, Deal C, Bass AR, Molina R, Erickson AR, Hausmann JS, Klein-Gitelman M, Imundo LF, Smith BJ, Jones K, Greene K, Monrad SU. 2015 American College of Rheumatology Workforce Study: Supply and Demand Projections of Adult Rheumatology Workforce, 2015-2030. Arthritis Care Res (Hoboken). 2018 Apr;70(4):617-626. doi: 10.1002/acr.23518.</citation>
      <PMID>29400009</PMID>
    </reference>
    <reference>
      <citation>Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008 Jan;61(1):17-33. doi: 10.1016/j.jclinepi.2006.06.025.</citation>
      <PMID>18083459</PMID>
    </reference>
    <reference>
      <citation>Lai JS, Cella D, Choi S, Junghaenel DU, Christodoulou C, Gershon R, Stone A. How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example. Arch Phys Med Rehabil. 2011 Oct;92(10 Suppl):S20-7. doi: 10.1016/j.apmr.2010.08.033.</citation>
      <PMID>21958919</PMID>
    </reference>
    <reference>
      <citation>Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.</citation>
      <PMID>20554116</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Daniel H. Solomon, M.D.,MPH</investigator_full_name>
      <investigator_title>Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>Arthritis</keyword>
    <keyword>Psoriatic Arthritis</keyword>
    <keyword>Mobile Health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis</mesh_term>
      <mesh_term>Arthritis, Psoriatic</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/NCT06004700
  org study id: 2021P000790
  nct id: NCT06004700
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The overall objective of this proposal is to test version 3.0 of the Arthritis smartphone app
        in a 12-month interrupted time series analysis (ITSA) design which will allow us to observe
        possible differences in visit frequency between the pre-and post-intervention periods as well
        as between the concurrent control group and those who receive the app. Our central hypothesis
        is that introduction of the app will reduce visit numbers per month in the group receiving
        the app, compared with a concurrent control group.
  Aim 1: To integrate an app for PsA into the EHR. In current work, user-centered design helped
        develop an EHR integrated PRO-based app for RA. The roll out of the app has been successful
        and the investigators now want to expand to focus on integration of a similar app for PsA.
        The app will use similar PROs, adding in a patient global VAS, as well as a brief psoriasis
        symptom checklist. The PROMIS Function Short Form, PROMIS Fatigue Short Form, PROMIS Pain
        Short Form, and the PsAID-12 will be assessed. As well, the Q&A function will be modified to
        focus on PsA, allowing one to monitor symptom changes for patients using various PsA
        treatments, focusing on guselkumab, infliximab, golimumab, and ustekinumab. Aim 1 is required
        for the app testing in Aim 2.
  
        Aim 2: To conduct a single arm interrupted time series of the EHR-integrated PRO app for PsA
        to assess whether it improves the timeliness of care. After integrating the app into the EHR,
        the investigators will recruit 100 patients who use one of the following agents: guselkumab,
        infliximab, golimumab, or ustekinumab. The goal will be to determine whether the app improves
        visit timeliness. Timeliness will be defined as an increase in the percent of visits with
        therapeutic changes over a 9-month trial period. A secondary outcome will assess PROs and
        visit satisfaction. The app allows patients to remotely transmit PRO data to their care team.
        Patients with very active disease between visits may consider a visit earlier than scheduled.
        The investigators hypothesize that during the intervention period with app use, patients will
        experience improved timeliness of PsA care when compared with the 9 months prior to the app
        use, while maintaining patient-reported clinical outcomes.
  
        Data collection will occur via three methods. First, RA/PsA patients will provide answers to
        the survey questions through the app on their smartphones or tablets and the ePRO data can be
        viewed in an administrative dashboard. Second, the app will push an in-basket message to
        rheumatologists letting them know 1 week before a patient visit that there are ePRO data in
        Epic to be viewed. If symptoms reach a threshold suggesting poor disease control, then prior
        to 1 week before the visit the app will send an in-basket message to the rheumatologists
        letting them know to review patient data to consider an earlier visit. On the other hand, if
        the ePRO data suggests stable symptoms, the app will push an in-basket message to the
        rheumatologist 1 week before the next patient visit suggesting that the rheumatologist could
        consider delaying the visit. The rheumatologist can respond as they see fit or not at all.
        The last data collection will occur at the end of study when a satisfaction survey will be
        completed through REDcap electronic consent.
  
        Analysis: The investigators anticipate near complete data, based on our prior studies.
        However, the investigators will impute missing values using standard imputation methods.
        Baseline characteristics of enrolled patients will be examined, assessing how well the
        recruited patients reflect a typical PsA population. The investigators will then examine the
        distribution of the visit timeliness (primary outcome) across the two time periods (pre and
        post app). Monthly percentage of visits that qualify as timely will be estimated across the
        study population. This allows us to assess the slopes during the two time periods. The
        investigators hypothesize improved timeliness of visits in the 9 months after starting to use
        the app compared with the pre-app 9 months. Thus, the primary analysis is a comparison of
        slopes. With respect to the secondary outcomes, the investigators will calculate the change
        from baseline to 9 months for each of the PROs. The distribution of PROs is typically normal.
        The investigators will compare baseline to ending values for each PRO using an ANCOVA. with
        an indicator term for rheumatologist. The investigators hypothesize that during this 9-month
        study the change in PROs will be within the minimally clinically important difference (i.e.,
        no change).
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  masking description: A matched control group will be enrolled from medical records. The data analyst will be blinded to the treatment assignment (i.e., app intervention or matched controls)
  measure: Visit Frequency
  time frame: 12 Months
  description: The differences in visit frequency, between the pre-and post-intervention periods and between the concurrent control group and those who receive the app
  measure: Patient Reported Outcomes Measurement Information System (PROMIS) Function short form
  time frame: 12 Months
  description: Each short form will be rotated and asked twice during an 8-day cycle.
  PROMIS is scored from 0-100. For the PROMIS Function, a higher score is better.
  measure: Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form
  time frame: 12 Months
  description: Each short form will be rotated and asked twice during an 8-day cycle.
  PROMIS is scored from 0-100. For the PROMIS Fatigue, a lower score is better.
  measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain short form
  time frame: 12 Months
  description: Each short form will be rotated and asked twice during an 8-day cycle.
  PROMIS is scored from 0-100. For the PROMIS Pain, a lower score is better.
  measure: Psoriatic Arthritis Impact of Disease 12-item questionnaire (PsAID-12) for Clinical Practice
  time frame: 12 Months
  description: Each short form will be rotated and asked twice during an 8-day cycle.
  The PsAID is calculated based on 12 Numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10. The total is divided by 20. Thus, the range of the final PsAID value is 0-10 where higher figures indicate worse status.
  measure: Standardized questionnaires for Arthritis Disease Activity
  time frame: 12 Months
  description: Each short form will be rotated and asked twice during an 8-day cycle.
  Questions include:
  i. How active is your arthritis today with respect to joint tenderness and swelling? ii. How severe is your arthritis pain today? iii. How would you describe your general health today? iv. Did you experience joint (hand) stiffness on awaking yesterday morning? If yes, how long was this stiffness?
  measure: Satisfaction with the App (patient and physician)
  time frame: Through study completion, an average of 1 year
  description: Patient Satisfaction with the App Physician Satisfaction with the App
  arm group label: Mobile Application
  arm group type: Experimental
  description: This arm of the study will contain half the study population after randomization. The participants in this arm will receive the EHR integrated app and follow a 12-month interrupted time series analysis (ITSA) design.
  n = 200
  arm group label: Controls
  arm group type: No Intervention
  description: This arm of the study will contain half the study population after randomization. The participants in this arm will be from the same rheumatologists as the experimental participants and will be used as concurrent controls by accessing their data on visits from the EHR during the same time period.
  n = 200
  intervention type: Other
  intervention name: Mobile Application
  description: The current app contains a disease activity questionnaire, a mood scale, a sleep scale, a pain scale, and a functional status scale. The app triggers a brief set of questions each day and allows patients to answer them within 24 hours.
  arm group label: Mobile Application
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacklyn Stratton
  phone: 617-525-8784
  email: jstratton1@bwh.harvard.edu
  citation: Battafarano DF, Ditmyer M, Bolster MB, Fitzgerald JD, Deal C, Bass AR, Molina R, Erickson AR, Hausmann JS, Klein-Gitelman M, Imundo LF, Smith BJ, Jones K, Greene K, Monrad SU. 2015 American College of Rheumatology Workforce Study: Supply and Demand Projections of Adult Rheumatology Workforce, 2015-2030. Arthritis Care Res (Hoboken). 2018 Apr;70(4):617-626. doi: 10.1002/acr.23518.
  PMID: 29400009
  citation: Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008 Jan;61(1):17-33. doi: 10.1016/j.jclinepi.2006.06.025.
  PMID: 18083459
  citation: Lai JS, Cella D, Choi S, Junghaenel DU, Christodoulou C, Gershon R, Stone A. How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example. Arch Phys Med Rehabil. 2011 Oct;92(10 Suppl):S20-7. doi: 10.1016/j.apmr.2010.08.033.
  PMID: 21958919
  citation: Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
  PMID: 20554116
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Daniel H. Solomon, M.D.,MPH
  investigator title: Professor of Medicine
  mesh term: Arthritis
  mesh term: Arthritis, Psoriatic
  sharing ipd: No