Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis

NCT02720874

Last updated date
Study Location
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Contact
310-222-4060

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis
Official Title  ICMJE Multidisciplinary Approach to Patient-Physician Partnership In Treating To Target In Rheumatoid Arthritis
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.
Detailed Description

One hundred and fifty Hispanic RA patients will be recruited for this proposal and randomized 1:1 to Intervention and Control arms for a period of 12 months. Participants will be recruited from the Adult Rheumatology clinic at Harbor-UCLA. Patients who meet enrollment criteria based on review of electronic medical records will be provided information about the study during regular outpatient visits. Interested patients will be formally screened.

After providing informed consent, eligible patients will complete baseline measures and be randomly assigned into Intervention and Control arms using a minimization protocol, with a goal of enrolling 150 patients (75 in each group). All participants will attend rheumatology clinic appointments scheduled quarterly for the 12-month trial duration, during which they will also complete assessments (at 3, 6, 9, and 12 months post-baseline; see description of outcomes for full detail). Between appointments with their assigned rheumatologist, participants will regularly self-monitor their RA symptoms using the Routine Assessment Patient Index Data (RAPID3) questionnaire administered via an interactive voice response (IVR) phone survey weekly for 12 months.

At baseline, participants will be enrolled in the IVR system and the study coordinator will provide a detailed orientation to the automated phone survey as well as written instructions including the toll-free phone number, and a unique study personal identification number. Participants will each select the day and the hours between which they will complete the weekly phone survey. After entering their unique study personal identification number, participants will complete the 12-item RAPID3 questionnaire, entering responses using their telephone keypad. If they do not call in and complete the survey on their preselected day during the specified time frame, they will receive a reminder call an hour later from the time by which they would have been expected to call in.

At the baseline visit, all participants will receive a rheumatoid arthritis educational booklet that provides general disease state information, including an overview of RA (e.g., its causes, associated symptoms, how it is diagnosed), RA medications and other treatment options, pain management, physical activity, nutrition and diet. The material is written at a sixth grade reading level and incorporates simple figures and graphics to enhance readability and promote participant comprehension and engagement. The study coordinator will also give each participant a pedometer and provide instruction for its use. Participants will be encouraged to wear the pedometer during waking hours and record their total daily steps in a log, along with the type and duration of other activities like swimming that pedometers do not capture.

Control arm participants will receive standard of care treatment from their assigned rheumatologists. Pharmacotherapy will be monitored and adjusted by the treating rheumatologist in accordance with evidence-based clinical practice guidelines. Physical Therapy referrals and evaluations will occur as indicated for addressing specific problems. Referral for psychological services will be provided when patients endorse symptoms of depression in response to a verbal screen or participant-initiated discussion. Control arm participants will also have regularly scheduled 20-30 minute monthly phone calls with the healthcare coordinator. While questions and concerns specifically raised by participants regarding study procedure and the content of the educational booklet will be addressed, these phone calls are primarily designed to control for potential benefit participants may derive from time on the phone with a health professional. The healthcare coordinator will engage participants using a non-directive approach based on use of active listening, reflective statements and similar techniques.

Intervention arm participants will receive integrated treatment from a multidisciplinary healthcare team during the routine clinic visits. In addition to appointments with their assigned rheumatologist, a physical therapist will assess participants' physical functioning, provide joint protection guidance and assist patients in making physical fitness plans based on their own goals and tailored to patients' abilities and physical limitations. Interim individual physical therapy sessions will be scheduled in accordance with the physical therapist's recommendations. Additionally, if during any routine clinic appointment a participant scores 10 or higher on the PHQ-9 and/or endorses symptoms of depression in response to a verbal screen, they will receive a same-day, in-clinic psychological evaluation. The psychologist will assess whether patient symptoms meet diagnostic criteria for a depressive disorder and, when clinically indicated, provide recommendations for treatment. Follow-up treatment appointments will be scheduled with patients by the psychologist.

In addition to regularly scheduled rheumatology appointments, if between-visit patient self-monitoring reports indicate an increase in RA disease activity (flare), participants in the intervention arm will be scheduled for an ad hoc evaluation with their assigned rheumatologist. Specifically, if participants' RAPID3 surveys show two consecutive week-to-week score increases and the cumulative two week RAPID3 increase is greater than 1.2 points, they will be contacted by the study coordinator that day (or following morning if surveys are completed after regular office hours) to schedule an ad-hoc appointment with their rheumatologist within 2 working days. During routine and ad hoc intervention arm patient visits, while clinical practice guidelines will inform rheumatologist monitoring of pharmacotherapy, the treatment planning process will be grounded in a shared decision making framework.

Participants in the intervention arm will further be provided a one-on-one tailored education session with a trained rheumatology nurse that will encompass a general disease state education, incorporating pictograms and short slide presentations, an introduction of the treat to target concept, overview of treatment options, and discussion of patient priorities and identification of personally salient long-term treatment-related goals. During regularly scheduled 20-30 minute monthly follow-up phone calls with each intervention arm participant, the rheumatology nurse will address individual educational needs, answer questions and reinforce learning. Goal setting, planning and review will also be conducted. Specifically, participants will select goals to be achieved in the upcoming month and be assisted in developing specific action plans. The rheumatology nurse will also check in about their work and progress on action plans discussed in the last phone call. Any barriers encountered will be explored and participants will be engaged in a problem-solving process, revising existing action plans as needed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Behavioral: Rheumatoid arthritis educational booklet
    Participants will receive a low-literacy rheumatoid arthritis educational booklet that provides general disease state information.
  • Behavioral: Multidisciplinary rheumatologic care
    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.
  • Behavioral: Nurse education and monthly calls
    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.
  • Behavioral: Monthly healthcare coordinator calls
    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.
  • Behavioral: Technology-based symptom monitoring and reporting
    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.
Study Arms  ICMJE
  • Experimental: Intervention Arm
    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.
    Interventions:
    • Behavioral: Rheumatoid arthritis educational booklet
    • Behavioral: Multidisciplinary rheumatologic care
    • Behavioral: Nurse education and monthly calls
    • Behavioral: Technology-based symptom monitoring and reporting
  • Active Comparator: Control Arm
    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.
    Interventions:
    • Behavioral: Rheumatoid arthritis educational booklet
    • Behavioral: Monthly healthcare coordinator calls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Elizabeth Hernandez310-222-4060[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02720874
Other Study ID Numbers  ICMJE 21625-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party George A Karpouzas, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Sponsor  ICMJE Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:George A Karpouzas, MDThe Lundquist Institute at Harbor-UCLA Medical Center
PRS Account Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP