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Living Well With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00869349
First received: March 25, 2009
Last updated: February 4, 2013
Last verified: February 2013

March 25, 2009
February 4, 2013
September 2008
December 2010   (final data collection date for primary outcome measure)
Improvement in health status, RA disease activity, and self-efficacy. [ Time Frame: Baseline,3, 6 and 9 months ] [ Designated as safety issue: No ]
Health status, function and RA disease activity will be documented by the swollen and tender joint count, CRP level and VAS scores. Self-efficacy will be measured with the Arthritis self-efficacy questionnaire.
  • Change in self-efficacy [ Time Frame: Baseline and at 3, 6 and 9 months ] [ Designated as safety issue: No ]
  • Improvement in health status and RA disease activity as documented by the swollen and tender joint count, crp level and VAS scores. [ Time Frame: Baseline, 6 and 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00869349 on ClinicalTrials.gov Archive Site
Improvement in depression and anxiety scores as well as self compassion [ Time Frame: Baseline, 3, 6 and 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Living Well With Rheumatoid Arthritis
Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.

The purpose of the Living Well with RA program is to perform a proof-of-concept study and evaluate the efficacy of an Internal Family Systems-based psychotherapeutic intervention improve Rheumatoid Arthritis subjects' disease activity, independence and other health outcomes. This study will also assess the efficacy of an IFS-based program in improving RA subjects' mental health symptoms. We hypothesize that the IFS model will improve RA subjects self-management of their disease and subsequently their health outcomes will improve as well as compared to a group focusing on arthritis education.

Subjects will be selected from the Brigham & Women's Hospital Arthritis Center and include those enrolled in the BRASS study and then once recruited randomly assigned to either the IFS intervention group or the education group. Both the IFS intervention and education group will participate in their respective programs simultaneously over 9 months.

Subject reported measures:

Incorporated into the questionnaires are several subject-reported measures, including: The Self-Compassion Scale, Beck Depression Index (BDI-II), SF-12 Health Survey, State-Trait Anxiety Inventory (STAI), RA Disease Activity Index (RADAI), and Arthritis Self-Efficacy Scale. These measures report emotional states, degree and location of arthritis pain, and how that pain affects their daily lives. A monthly encounter form will also be completed by the subject.

Physician measures:

The physicians who will be monitoring subject health are blind to the study and complete the same measures for subjects in both the IFS intervention and education groups. They will complete a joint count, Global Assessment of health, duration of morning stiffness and ACR functional status.

Laboratory testing:

Subjects will give blood at the beginning, 3, 6 and 9-month points of the program. This sample will be laboratory-tested for C-reactive protein.

Data collection schedule:

Subjects will complete a questionnaire at baseline, then at 3, 6 and 9 months. They will give blood samples and undergo a routine physical examination, focusing on their joints at the initial meeting, again at 3, 6, and 9 months into the study.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Rheumatoid Arthritis
  • Behavioral: IFS

    The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.

    Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline.

  • Other: Education
    The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
  • Experimental: IFS Intervention Group
    Intervention: Behavioral: IFS
  • Active Comparator: Education Group
    Intervention: Other: Education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active RA symptoms
  • Member of the BRASS registry at the Brigham and Women's Arthritis Clinic
  • Ability to attend group and individual sessions consistently

Exclusion Criteria:

  • RA has been in remission for one year
  • Subjects who are currently enrolled in the Arthritis Foundation Self- Management course or any similar type of course
Both
18 Years to 81 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869349
2002-P-001762
No
Nancy Shadick, Brigham and Women's Hospital
Brigham and Women's Hospital
Bristol-Myers Squibb
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
February 2013

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