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

NCT06004700 | Active Not Recruiting

• 1 other identifier: 2021P000790
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Psoriatic Arthritis

Keywords

Arthritis; Psoriatic Arthritis; Mobile Health

Outcome Measures

Primary Outcomes (1)

• 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

  12 Months

Secondary Outcomes (6)

• Patient Reported Outcomes Measurement Information System (PROMIS) Function short form

  12 Months

• Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form

  12 Months

• Patient Reported Outcomes Measurement Information System (PROMIS) Pain short form

  12 Months

• Psoriatic Arthritis Impact of Disease 12-item questionnaire (PsAID-12) for Clinical Practice

  12 Months

• Standardized questionnaires for Arthritis Disease Activity

  12 Months

Study Arms (2)

Mobile Application

EXPERIMENTAL

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 = 260

Other: Mobile Application

Controls

NO INTERVENTION

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 = 260

Interventions

Mobile Application OTHER

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.

Mobile Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who do not plan on receiving follow-up care at the Brigham and Women's Arthritis Center will be excluded.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Arthritis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: April 11, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)