Living Well With Rheumatoid Arthritis



Status:Archived
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2008
End Date:December 2010

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Brigham Rheumatoid Arthritis Sequential Study B.R.A.S.S.


The purpose of the Living Well with RA program is to evaluate the efficacy of an Internal
Family Systems-based arthritis self-management program in improving 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
intervention group or the control group. Both the intervention and control 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), Arthritis Self-Efficacy Scale,
and Multidimensional Health Assessment Questionnaire (MDHAQ). 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 intervention and control groups. They will complete
a 44 joint count, Global Assessment of health, duration of morning stiffness and ACR
functional status.

Laboratory testing:

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

Audiotaping:

Individual coaching sessions will be audiotaped for data collection and quality control.
Tapes will be coded for content but blinded to subject and coach identity.

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 the 6-month point, and finally at the completion of the 9
months. Coaching subjects will also complete an encounter form evaluating their current
status once a month at their individual session.


We found this trial at
1
site
850 Boylston Street
Chestnut Hill, Massachusetts 02467
1-800-BWH-9999
Brigham & Women's Hospital Women's Health Center At Brigham and Women
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mi
from
Chestnut Hill, MA
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