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Improving Virtual Care of Arthritis: Integrating a Smartphone App Into the EHR for Improved Timeliness of Visits (RAPID-PsA)

Primary Purpose

Arthritis, Psoriatic Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Application
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis focused on measuring Arthritis, Psoriatic Arthritis, Mobile Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be diagnosed with PsA by a board-certified rheumatologist and been seen at least twice in the prior year Own a smartphone with either an Android or iPhone operating system Be at least 18 years old Be English-speaking Using guselkumab, infliximab, golimumab or ustekinumab Exclusion Criteria: Patients who do not plan on receiving follow-up care at the Brigham and Women's Arthritis Center will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mobile Application

    Controls

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Visit Frequency
    The differences in visit frequency, between the pre-and post-intervention periods and between the concurrent control group and those who receive the app

    Secondary Outcome Measures

    Patient Reported Outcomes Measurement Information System (PROMIS) Function short form
    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.
    Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form
    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.
    Patient Reported Outcomes Measurement Information System (PROMIS) Pain short form
    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.
    Psoriatic Arthritis Impact of Disease 12-item questionnaire (PsAID-12) for Clinical Practice
    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.
    Standardized questionnaires for Arthritis Disease Activity
    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?
    Satisfaction with the App (patient and physician)
    Patient Satisfaction with the App Physician Satisfaction with the App

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    Janssen Scientific Affairs, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06004700
    Brief Title
    Improving Virtual Care of Arthritis: Integrating a Smartphone App Into the EHR for Improved Timeliness of Visits
    Acronym
    RAPID-PsA
    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) (RAPID-PsA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    Janssen Scientific Affairs, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthritis, Psoriatic Arthritis
    Keywords
    Arthritis, Psoriatic Arthritis, Mobile Health

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile Application
    Arm Type
    Experimental
    Arm 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 Title
    Controls
    Arm Type
    No Intervention
    Arm 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(s)
    Mobile Application
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Visit Frequency
    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
    Time Frame
    12 Months
    Secondary Outcome Measure Information:
    Title
    Patient Reported Outcomes Measurement Information System (PROMIS) Function short form
    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.
    Time Frame
    12 Months
    Title
    Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form
    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.
    Time Frame
    12 Months
    Title
    Patient Reported Outcomes Measurement Information System (PROMIS) Pain short form
    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.
    Time Frame
    12 Months
    Title
    Psoriatic Arthritis Impact of Disease 12-item questionnaire (PsAID-12) for Clinical Practice
    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.
    Time Frame
    12 Months
    Title
    Standardized questionnaires for Arthritis Disease Activity
    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?
    Time Frame
    12 Months
    Title
    Satisfaction with the App (patient and physician)
    Description
    Patient Satisfaction with the App Physician Satisfaction with the App
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Be diagnosed with PsA by a board-certified rheumatologist and been seen at least twice in the prior year Own a smartphone with either an Android or iPhone operating system Be at least 18 years old Be English-speaking Using guselkumab, infliximab, golimumab or ustekinumab Exclusion Criteria: Patients who do not plan on receiving follow-up care at the Brigham and Women's Arthritis Center will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacklyn Stratton
    Phone
    617-525-8784
    Email
    jstratton1@bwh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29400009
    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.
    Results Reference
    background
    PubMed Identifier
    18083459
    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.
    Results Reference
    background
    PubMed Identifier
    21958919
    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.
    Results Reference
    background
    PubMed Identifier
    20554116
    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.
    Results Reference
    background

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    Improving Virtual Care of Arthritis: Integrating a Smartphone App Into the EHR for Improved Timeliness of Visits

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