Patient Rheumatoid Arthritis Social Support Study (PARASS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01525654
First received: February 1, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Behavioral: Peer Support Program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Rheumatoid Arthritis Patient-to-Patient Connection Program

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • change in functional status [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    functional status is measured by the MDHAQ doing scale and flare activity

  • change in medication adherence [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    assessed with the ASK-20 medication adherence questionnaire


Secondary Outcome Measures:
  • change in self-efficacy [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    assessed using the Arthritis Self-Efficacy Scale

  • change in fatigue [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    assessed by the MDHAQ VAS fatigue question

  • change in pain [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    assessed by the MDHAQ VAS pain question


Estimated Enrollment: 65
Study Start Date: March 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525654

Contacts
Contact: Brett Pantera 617-525-6608 bpantera@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nancy A Shadick, MD, MPH    617-732-5266    nshadick@partners.org   
Contact: Christine K Iannaccone, MPH    617-732-5083    ciannaccone@partners.org   
Principal Investigator: Nancy A Shadick, MD, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Amgen
  More Information

Additional Information:
Publications:

Responsible Party: Nancy Shadick, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01525654     History of Changes
Other Study ID Numbers: 2006P000795
Study First Received: February 1, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Rheumatoid Arthritis
peer support
self-efficacy
medication adherence

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014