Patient Rheumatoid Arthritis Social Support Study (PARASS)

September 23, 2025 updated by: Nancy Shadick, Brigham and Women's Hospital

Rheumatoid Arthritis Patient-to-Patient Connection Program

The goal of PARASS is to develop a network of increased social support for Rheumatoid Arthritis (RA) patients that will improve patient outcomes and further promote understanding of RA among physicians and patients in the clinic community. This will be accomplished with the development and implementation of Buddy pairing and one -on- one informational support to be called Patient-to-Patient Connection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Rheumatoid arthritis (RA) is a chronic disabling disease that affects nearly 1% of the U. S. population [1]. The illness causes destruction of joint cartilage and erosion of adjacent bone, leading to joint replacement as well as extra-articular disease including cardiopulmonary manifestations, vasculitis, gastrointestinal and infectious complications [2]. Many patients with RA over time suffer progressive disability [3, 4], pain [5], work loss [3, 6], substantial health care costs [7], and premature mortality [8]. The current treatment of RA results in only modest improvements in functional status and many patients progress to chronic disability. Treatment is focused on ameliorating symptoms and halting disease progression as early as possible to prevent joint damage and functional decline.

Research has shown that while patient response to different medications may vary, those with chronic illness universally require social support and human empathy to achieve the best physical and emotional outcomes. From the 2006 PACO focus groups, we learned that RA patients' greatest concern was social isolation, that almost all had never talked with another person with RA, and that they feel alone dealing with the challenges of the disease. Psychosocial support is a seminal aspect of disease management since interpersonal relationships are often affected by the fatigue and physical disability of the disease and self-efficacy by the resulting loss of independence. The purpose of this study is to further patient care by providing social support services to better arthritis outcomes and patient satisfaction. In this pilot initiative called PARASS Patient-to-Patient Connection, patients will be able to connect with fellow patients who have similar concerns and fears and can find empathy and understanding based on personal experience. Buddy systems matching patients with similar needs or interests have been successful in addiction rehabilitation and oncology treatment, and group sessions have long been used as teaching and support tools in diabetes management. Rheumatology, however, has to date focused largely on providing patients with tools to improve the more physical manifestations of pain, swelling and fatigue. Furthermore, efforts to enhance self efficacy through leader initiated self help courses have not produced expected improvements in clinical outcomes. The purpose of this initiative is to develop a novel method of patient empowerment using peer support in order to better arthritis outcomes and patient satisfaction. To our knowledge, no rheumatology clinics in the United States have developed or instituted organized programs for peer social support or group informational discussion.

The goal of PARASS is to develop a network of increased social support for Rheumatoid Arthritis (RA) patients that will improve patient outcomes and further promote understanding of RA among physicians and patients in the clinic community. This will be accomplished with the development and implementation of a "buddy pairing" program called Patient-to-Patient Connection.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • billing diagnosis of rheumatoid arthritis (714.0) or seronegative inflammatory arthritis or a member of the BRASS and PACO studies at Brigham and Women's Hospital

Exclusion Criteria:

  • less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Partners
Patients who are matched with support partners and have a billing diagnosis of RA (714.0) or seronegative inflammatory arthritis who are enrolled in the Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS) or the Patient-Centered Outcomes Initiative (PACO)
Behavioral: Peer Support Program
Partners, are interested in having a support person to talk with while others. Coaches initiate contact, usually via phone but can use email or face to face, with their Partner. During this initial contact, partners determine how often to speak up to a total of 6 months. Peer Support discussions focus on sharing information, education, support related to living with RA.
No Intervention: Controls
Controls will be BRASS patients who continue to receive regular care without being matched with a peer support partner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in functional status
Time Frame: baseline and 6 months
functional status is measured by the Multi Dimensional Health Assessment Questionnaire doing scale and flare activity
baseline and 6 months
change in medication adherence
Time Frame: baseline and 6 months
assessed with the Adherence Barrier Survey-20 medication adherence questionnaire
baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in self-efficacy
Time Frame: baseline and 6 months
assessed using the Arthritis Self-Efficacy Scale
baseline and 6 months
change in fatigue
Time Frame: baseline and 6 months
assessed by the Multi Dimensional Health Assessment Questionnaire Visual Analog Scale fatigue question
baseline and 6 months
change in pain
Time Frame: baseline and 6 months
assessed by the Multi Dimensional Health Assessment Questionnaire Visual Analog Scale pain question
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (Estimated)

February 3, 2012

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006P000795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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