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临床试验/NCT02720874
NCT02720874撤回不适用

Multidisciplinary Approach to Patient-Physician Partnership In Treating To Target In Rheumatoid Arthritis

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
150
试验地点
1
主要终点
Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Rheumatoid arthritis educational booklet (Behavioral)

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.

干预措施: Rheumatoid arthritis educational booklet (Behavioral)

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.

干预措施: Multidisciplinary rheumatologic care (Behavioral)

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.

干预措施: Nurse education and monthly calls (Behavioral)

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.

干预措施: Technology-based symptom monitoring and reporting (Behavioral)

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.

干预措施: Monthly healthcare coordinator calls (Behavioral)

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • 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)
  • Change in Patient Health Questionnaire (PHQ-9) depression from baseline(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Change in Patient Global Assessment of disease activity (PGA) from baseline(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Change in Pain Visual Analogue Scale (VAS) from baseline(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Change in Fatigue Visual Analogue Scale (VAS) from baseline(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Change in SF-36 health status from baseline(Baseline, 3 months, 6 months, 9 months, 12 months)
  • Change in Rheumatoid Arthritis Specific Work Productivity Survey (WPS-RA) from baseline(Baseline, 3 months, 6 months, 9 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George A Karpouzas, MD

Associate Professor of Medicine, UCLA, Chief, Division of Rheumatolgy, Harbor-UCLA Medical Center

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

研究点 (1)

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