Rheumatoid Arthritis Clinical Trial
Official title:
Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention
Verified date | December 2013 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. The purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.
Status | Completed |
Enrollment | 134 |
Est. completion date | December 2006 |
Est. primary completion date | August 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Native English speaker - Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts - Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Kitsch I, A. Jungeblut, L. Jenkins, and A. Kolstad. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, DC: National Center for Education Statistics, US Department of Education; 1993.
Weiss BD, Hart G, McGee DL, D'Estelle S. Health status of illiterate adults: relation between literacy and health status among persons with low literacy skills. J Am Board Fam Pract. 1992 May-Jun;5(3):257-64. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Literacy-related problems encountered in management | Interview | 6 months and 12 months | No |
Primary | Adherence to treatment | self report of medication use on standard form | 6 months, 12 months | No |
Primary | Self efficacy | self report on self efficacy form | 6 months and 12 months | No |
Primary | Satisfaction with medical care | self report of satisfaction | 6 months and 12 months | No |
Secondary | Heath Status | Health Assessment questionaire | 6 months and 12 months | No |
Secondary | Mental Health | SF-36 (5 items) | 6 months and 12 months | No |
Secondary | Understanding of medication | open ended questionnaire of medication purpose | 6 months and 12 months | No |
Secondary | Perceived usefulness of materials | Interview | 6months and 12 months | No |
Secondary | Appointment keeping | Clinical record | 6 and 12 months | No |
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