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Shared Decision Making Intervention for Rheumatoid Arthritis (RAiSeD Trial)
N/A
Recruiting
Led By Jennifer Barton, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (up to 4 years), on average 3 times per year
Awards & highlights
RAiSeD Trial Summary
This trial will test whether a shared decision making intervention can help reduce disease activity, improve medication adherence, and increase patient knowledge about RA in Veterans Affairs (VA) patients with RA.
Who is the study for?
This trial is for adults with moderate to high rheumatoid arthritis activity who have been treated at participating clinics in the past year. It includes patients, clinicians, and non-clinician leaders involved in RA care. Participants must speak English and not have cognitive impairments that would prevent participation.Check my eligibility
What is being tested?
The study tests a shared decision-making intervention aimed at improving RA disease outcomes. This involves an RA medication guide (RA Choice), training clinicians on communication, and activating patients to engage in their treatment choices.See study design
What are the potential side effects?
Since this trial focuses on decision-making rather than new medications, it does not directly test treatments with side effects. However, any standard side effects of current RA medications may still apply to participants.
RAiSeD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (up to 4 years), on average 3 times per year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (up to 4 years), on average 3 times per year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease activity
Secondary outcome measures
Change in OPTION-5 (objective measure of shared decision making)
Change in adherence
Change in rheumatoid arthritis knowledge
+2 moreRAiSeD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment3 Interventions
Intervention phase
Group II: ControlActive Control1 Intervention
Usual care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient activation
2019
N/A
~320
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,304,392 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
222 Patients Enrolled for Rheumatoid Arthritis
Jennifer Barton, MDPrincipal InvestigatorVA Portland Health Care System, Portland, OR
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to speak.My condition meets the official criteria for rheumatoid arthritis.I am 18 years old or older.People who work as rheumatology doctors, trainees, or advanced practice providers (nurse practitioners or physician assistants) at the related clinics.I have been in a leadership role at my institution for less than a year.I have been seen by a rheumatologist at a participating clinic in the last year.I am 18 years old or older.My rheumatoid arthritis has been moderate to severe in the last 18 months.My condition is officially diagnosed as rheumatoid arthritis.You must be able to speak English.I've seen a rheumatologist at a participating clinic in the last year.My rheumatoid arthritis has been active in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05530694 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are engaged in the research project?
"Affirmative. Clinicaltrials.gov attests that this clinical trial, which first appeared on September 19th 2022, is actively seeking out participants. 2196 patients need to be enrolled from 3 distinct medical sites."
Answered by AI
Are there any opportunities at present for participants to join this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research is actively searching for participants who meet the criteria set out in their post from September 19th 2022 and updated on October 7th 2022. The study requires 2196 patients to be recruited at three different sites."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Why did patients apply to this trial?
Over the counter medicine for rhumatoid arthritis and now symptoms of pain so severe that my doc calls it fibamialgia severe pain stage.
PatientReceived 2+ prior treatments
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