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Behavioural Intervention
Mobile App for Arthritis (RAPID-PsA Trial)
N/A
Recruiting
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Using guselkumab, infliximab, golimumab, or ustekinumab
At least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new version of a smartphone app for arthritis over 12 months. Researchers will compare how often people visit their healthcare providers before and after using the app. They will also compare
Who is the study for?
This trial is for adults over 18 with Psoriatic Arthritis (PsA), diagnosed by a specialist, who've had at least two appointments in the past year. Participants must speak English and own an Android or iPhone smartphone. They should be using specific arthritis medications like guselkumab or infliximab.
What is being tested?
The study tests if a new version of the Arthritis app can change how often patients need to visit doctors. It compares visit frequency before and after introducing the app, and against a control group not using the app, over 12 months.
What are the potential side effects?
Since this trial involves a mobile application rather than medication, traditional side effects are not expected. However, users may experience issues related to usability such as difficulty navigating the app or technical glitches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently using guselkumab, infliximab, golimumab, or ustekinumab.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with Psoriatic Arthritis by a specialist and have had at least two appointments in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visit Frequency
Secondary study objectives
Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue short form
Patient Reported Outcomes Measurement Information System (PROMIS) Function short form
Patient Reported Outcomes Measurement Information System (PROMIS) Pain short form
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile ApplicationExperimental Treatment1 Intervention
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
Group II: ControlsActive Control1 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 = 200
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,877,416 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,573 Total Patients Enrolled