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Supportive Care for Arthritis (RAISE Trial)
N/A
Waitlist Available
Led By Candace H Feldman, MD, MPH, ScD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -12 months through +12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests whether providing tailored lists of resources and/or a specialized nurse navigator to patients with inflammatory arthritis and SDoH-related needs can reduce missed appointments and improve health outcomes.
Who is the study for?
This trial is for adults over 18 with arthritis-related rheumatic conditions who missed at least one clinic visit in the past year and have social needs, except unemployment or education. They must be getting care at specific hospitals, speak English or Spanish, and not be enrolled in certain other care programs.
What is being tested?
The study tests three support strategies for patients with systemic rheumatic conditions: a tailored resource list (Arm 1), help from a community specialist (Arm 2), and assistance from a nurse navigator trained in these conditions working with the community specialist (Arm 3).
What are the potential side effects?
Since this trial involves non-medical interventions like providing resources and personal guidance rather than drugs or medical procedures, traditional side effects are not expected. However, there may be indirect effects on patients' well-being based on their experiences.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ -12 months through +12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-12 months through +12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patient no-shows
Secondary study objectives
Acute care use for avoidable conditions
Acute care use overall
Disability metric
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment1 Intervention
Arm 3 will receive the assistance of a bilingual (English and Spanish) nurse patient navigator with nursing training and additional rheumatology-specific training.
Group II: Arm 2Experimental Treatment1 Intervention
Arm 2 will receive the assistance of a community resource specialist (CRS)- an individual without formal medical training with community-based expertise.
Group III: Arm 1Experimental Treatment1 Intervention
Arm 1 is the control arm which will receive the standard of care resource sheets.
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Who is running the clinical trial?
Bristol-Myers Squibb FoundationUNKNOWN
5 Previous Clinical Trials
1,246 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,664 Previous Clinical Trials
11,834,728 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,726 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have chosen not to be contacted for research in my electronic health records.I speak English or Spanish.I have been diagnosed with a rheumatic condition that causes joint inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 3
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.
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