Patient Rheumatoid Arthritis Social Support Study (PARASS)
|ClinicalTrials.gov Identifier: NCT01525654|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2012
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Behavioral: Peer Support Program|
Rheumatoid arthritis (RA) is a chronic disabling disease that affects nearly 1% of the U. S. population . 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 . Many patients with RA over time suffer progressive disability [3, 4], pain , work loss [3, 6], substantial health care costs , and premature mortality . 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 (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rheumatoid Arthritis Patient-to-Patient Connection Program|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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.
- 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
- change in medication adherence [ Time Frame: baseline and 6 months ]assessed with the Adherence Barrier Survey-20 medication adherence questionnaire
- change in self-efficacy [ Time Frame: baseline and 6 months ]assessed using the Arthritis Self-Efficacy Scale
- change in fatigue [ Time Frame: baseline and 6 months ]assessed by the Multi Dimensional Health Assessment Questionnaire Visual Analog Scale fatigue question
- change in pain [ Time Frame: baseline and 6 months ]assessed by the Multi Dimensional Health Assessment Questionnaire Visual Analog Scale pain question
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525654
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|