Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis

NCT02720874 | Withdrawn

• 1 other identifier: 21625-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and adherence to the principles of treat-to-target strategy. The primary hypothesis of this study is that the addition of a multifaceted intervention incorporating integrated multidisciplinary rheumatologic care, nurse-directed self-management education and supportive follow-up, and technology-based at home RA symptom monitoring and reporting to clinical guideline-based care will increase RA remission rate at 6 months.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (2)

• Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months

  Remission as defined by a Clinical Disease Activity Index (CDAI) score ≤ 2.8. The CDAI is a pooled disease activity index based on the swollen joint count (0-28), tender joint count (0-28), patient global estimate (0-10), and physician global estimate (0-10); the CDAI scale ranges from 0-76, where higher scores represent higher disease activity.

  6 months

• Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 6 months

  Remission as defined by a Routine Assessment Patient Index Data (RAPID3) score ≤ 1. The RAPID3 is a self-report measure of disease activity and represents the average of patient ratings for physical function, pain and disease activity. Total RAPID3 scores range from 0 to 10, where higher scores represent higher patient-rated disease activity.

  6 months

Secondary Outcomes (11)

• Percentage of participants achieving remission based on the Clinical Disease Activity Index at 12 months

  12 months

• Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 12 months

  12 months

• Percentage of participants with low disease activity based on the Clinical Disease Activity Index

  6 months, 12 months

• Percentage of participants with low disease activity based on the Routine Assessment Patient Index Data

  6 months, 12 months

• Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline

  Baseline, 3 months, 6 months, 9 months, 12 months

Other Outcomes (6)

• Brief Illness Perception Questionnaire (BIPQ)

  Baseline, 6 months, 12 months

• Single Item Health Literacy Screener (SILS)

  Baseline, 6 months, 12 months

• Patient Knowledge Questionnaire in Rheumatoid Arthritis (PKQ-RA)

  Baseline, 6 months, 12 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

In the multifaceted intervention, participants will first receive an educational session with monthly follow-up phone calls from a trained rheumatology nurse. A rheumatoid arthritis educational booklet will also be provided. During regularly scheduled clinic appointments (at baseline, 3 months, 6 months, 9 months, and 12 months), participants will receive multidisciplinary rheumatologic care, including evaluation by a rheumatologist, physical therapist and psychologist. In addition, participants will be scheduled for ad hoc rheumatology appointments if technology-based symptom monitoring and reporting indicates a marked increase in RA disease activity.

Behavioral: Rheumatoid arthritis educational booklet; Behavioral: Multidisciplinary rheumatologic care; Behavioral: Nurse education and monthly calls; Behavioral: Technology-based symptom monitoring and reporting

Control Arm

ACTIVE COMPARATOR

Participants will receive standard of care treatment from their assigned rheumatologists during routine clinic appointments scheduled quarterly for the 12-month trial duration. Referrals to ancillary services will occur in a standard of care fashion. Participants will additionally receive monthly healthcare coordinator calls and be given the rheumatoid arthritis educational booklet.

Behavioral: Rheumatoid arthritis educational booklet; Behavioral: Monthly healthcare coordinator calls

Interventions

Rheumatoid arthritis educational booklet BEHAVIORAL

Participants will receive a low-literacy rheumatoid arthritis educational booklet that provides general disease state information.

Control Arm; Intervention Arm

Multidisciplinary rheumatologic care BEHAVIORAL

At each regularly scheduled clinic appointment, participants will receive treatment from their assigned rheumatologist, undergo an in-clinic physical therapy evaluation and, if indicated, a psychological evaluation. Physical therapy and psychology follow-up sessions will occur as directed by the individual services.

Intervention Arm

Nurse education and monthly calls BEHAVIORAL

Participants will meet one-on-one with a rheumatology nurse for a tailored educational session encompassing disease state education, an introduction of the treat to target concept, an overview of treatment options, and goal setting and planning. During monthly follow-up calls, participant educational needs will be addressed; goal setting, planning and review will also be conducted.

Intervention Arm

Monthly healthcare coordinator calls BEHAVIORAL

During monthly calls with the healthcare coordinator, specific questions and concerns raised by participants may be addressed. The primary purpose of these calls is to control for potential benefit derived from time on the phone with a health professional.

Control Arm

Technology-based symptom monitoring and reporting BEHAVIORAL

When at home patient self-monitoring reports indicate a significant increase in RA disease activity, participants will be promptly contacted and scheduled for an ad hoc evaluation with their treating rheumatologist.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

• Reside in Greater Los Angeles area and receive rheumatologic care at the adult rheumatology clinic at Harbor-UCLA Medical Center in Torrance, California
• Fulfill the 2010 American College of Rheumatology revised diagnostic criteria for RA
• Have at least moderate disease activity as indicated by a Clinical Disease Activity Index (CDAI) score \>10 and Routine Assessment Patient Index Data (RAPID3) score \>2
• Be able and willing to provide written informed consent and to adhere to the study visit schedule and other protocol
• Availability of a touch-tone landline or mobile telephone
• Of self-identified Hispanic/Latino descent

You may not qualify if:

• Known irreversible articular damage, including subluxations, arthrodesis, fusion, or prosthesis
• Functional class IV as defined by the American College of Rheumatology Classification of Functional Status in rheumatoid arthritis
• Overlapping autoimmune or mixed connective tissue syndromes
• Serious medical conditions, including: chronic infection, advanced or decompensated heart failure, higher than class II chronic kidney disease, cancer (unless in remission for period of 5 years or more), or any uncontrolled medical condition that is deemed by the investigators to interfere with the study protocol
• At risk for suicide

Sponsors & Collaborators

• Pfizer: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

The Lundquist Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• George A Karpouzas, MD

  The Lundquist Institute at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, UCLA, Chief, Division of Rheumatolgy, Harbor-UCLA Medical Center

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 28, 2016
• Study Start: January 1, 2025
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)