Arm 2 for Systemic Sclerosis

Brigham & Women's Hospital, Boston, MA
Systemic Sclerosis+14 More ConditionsCommunity Resource Specialist - Other
Eligibility
18 - 100
All Sexes

Study 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.

Eligible Conditions
  • Rheumatoid Arthritis
  • Lupus
  • Enteropathic Arthropathies
  • Progressive Systemic Sclerosis
  • Sjogren's Syndrome
  • Undifferentiated Connective Tissue Disease
  • Palindromic Arthritis
  • Juvenile Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Sacroiliitis
  • Psoriatic Arthritis
  • Mixed Connective Tissue Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: -12 months through +12 months

Month 12
Patient no-shows
Reduction of Social Determinants of Health-related needs in EHR data
Reduction of Social Determinants of Health-related needs in institution-created questionnaire
Month 12
Patient trust in providers
0 through +12 months
Acute care use for avoidable conditions
Acute care use overall
Disability metric
Inflammatory Arthritis Checklist
Lupus Checklist
Medication adherence through medication refill data
Medication adherence through patient questionnaire
Patient anxiety & depression
Patient discrimination
Patient satisfaction
Patient stress
Self efficacy
Treat-to-target metrics

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm 2
1 of 2
Arm 3
1 of 2

Experimental Treatment

258 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 2 · No Placebo Group · N/A

Arm 2
Other
Experimental Group · 1 Intervention: Community Resource Specialist · Intervention Types: Other
Arm 3
Other
Experimental Group · 1 Intervention: Nurse Navigator · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: -12 months through +12 months

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,542 Previous Clinical Trials
4,019,398 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,517 Previous Clinical Trials
11,303,762 Total Patients Enrolled
Bristol-Myers Squibb FoundationUNKNOWN
5 Previous Clinical Trials
1,246 Total Patients Enrolled
Candace H Feldman, MD, MPH, ScDPrincipal InvestigatorBrigham and Women's Hospital

Eligibility Criteria

Age 18 - 100 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with inflammatory arthritis.

Frequently Asked Questions

Are individuals over 45 eligible for participation in this experiment?

"According to the official guidelines for this trial, individuals aged 18-100 are eligible to enroll as participants." - Anonymous Online Contributor

Unverified Answer

How many individuals have registered to partake in this research?

"Affirmative. Clinicaltrials.gov data reveals that this medical project, which was originally introduced on February 28th 2023 is presently recruiting participants to take part in the trial. 258 individuals must be recruited from one site for the study to be completed successfully." - Anonymous Online Contributor

Unverified Answer

Does this clinical trial still have open slots for volunteers?

"Absolutely, according to clinicaltrials.gov this medical trial is accepting participants at the current time. The trial was initially posted on February 28th 2023 and updated most recently on February 22nd 2023. 258 patients are required from a single site for enrollment in this study." - Anonymous Online Contributor

Unverified Answer

What demographic is best suited to participate in this experiment?

"For this clinical trial, 258 participants with a confirmed diagnosis of rheumatoid arthritis, aged 18 years and above are being recruited. Notably, they need to be able to communicate in either English or Spanish language; have missed an appointment at a health care provider within the past year; express one or more social determinants of health needs on the Mass General Brigham questionnaire (except for unemployment and education); and receive their current medical treatment from either Faulkner Hospital or Brigham and Women's Hospital clinics." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.