NCT01525654

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

February 1, 2012

Last Update Submit

September 23, 2025

Conditions

Keywords

Rheumatoid Arthritispeer supportself-efficacymedication adherence

Outcome Measures

Primary Outcomes (2)

  • change in functional status

    functional status is measured by the Multi Dimensional Health Assessment Questionnaire doing scale and flare activity

    baseline and 6 months

  • change in medication adherence

    assessed with the Adherence Barrier Survey-20 medication adherence questionnaire

    baseline and 6 months

Secondary Outcomes (3)

  • change in self-efficacy

    baseline and 6 months

  • change in fatigue

    baseline and 6 months

  • change in pain

    baseline and 6 months

Study Arms (2)

Partners

ACTIVE COMPARATOR

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

Controls

NO INTERVENTION

Controls will be BRASS patients who continue to receive regular care without being matched with a peer support partner.

Interventions

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.

Partners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (10)

  • Linos A, Worthington JW, O'Fallon WM, Kurland LT. The epidemiology of rheumatoid arthritis in Rochester, Minnesota: a study of incidence, prevalence, and mortality. Am J Epidemiol. 1980 Jan;111(1):87-98. doi: 10.1093/oxfordjournals.aje.a112878.

    PMID: 7352462BACKGROUND
  • Pincus T, Callahan LF, Sale WG, Brooks AL, Payne LE, Vaughn WK. Severe functional declines, work disability, and increased mortality in seventy-five rheumatoid arthritis patients studied over nine years. Arthritis Rheum. 1984 Aug;27(8):864-72. doi: 10.1002/art.1780270805.

    PMID: 6431998BACKGROUND
  • Sherrer YS, Bloch DA, Mitchell DM, Young DY, Fries JF. The development of disability in rheumatoid arthritis. Arthritis Rheum. 1986 Apr;29(4):494-500. doi: 10.1002/art.1780290406.

    PMID: 3707627BACKGROUND
  • Callahan LF, Brooks RH, Summey JA, Pincus T. Quantitative pain assessment for routine care of rheumatoid arthritis patients, using a pain scale based on activities of daily living and a visual analog pain scale. Arthritis Rheum. 1987 Jun;30(6):630-6. doi: 10.1002/art.1780300605.

    PMID: 3606681BACKGROUND
  • Yelin E, Meenan R, Nevitt M, Epstein W. Work disability in rheumatoid arthritis: effects of disease, social, and work factors. Ann Intern Med. 1980 Oct;93(4):551-6. doi: 10.7326/0003-4819-93-4-551.

    PMID: 7436187BACKGROUND
  • Meenan RF, Yelin EH, Henke CJ, Curtis DL, Epstein WV. The costs of rheumatoid arthritis. A patient-oriented study of chronic disease costs. Arthritis Rheum. 1978 Sep-Oct;21(7):827-33. doi: 10.1002/art.1780210714.

    PMID: 100122BACKGROUND
  • Pincus T, Brooks RH, Callahan LF. Prediction of long-term mortality in patients with rheumatoid arthritis according to simple questionnaire and joint count measures. Ann Intern Med. 1994 Jan 1;120(1):26-34. doi: 10.7326/0003-4819-120-1-199401010-00005.

    PMID: 8250453BACKGROUND
  • Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.

    PMID: 2912463BACKGROUND
  • Hahn SR, Park J, Skinner EP, Yu-Isenberg KS, Weaver MB, Crawford B, Flowers PW. Development of the ASK-20 adherence barrier survey. Curr Med Res Opin. 2008 Jul;24(7):2127-38. doi: 10.1185/03007990802174769. Epub 2008 Jun 12.

    PMID: 18554431BACKGROUND
  • Harris, E.D., Rheumatoid arthritis. 1997, Philadelphia: Saunders. xxiii, 433.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidMedication Adherence

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

March 1, 2009

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations