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| Sponsor: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|---|---|
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00023205 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Psoriatic Arthritis Polyarthritis |
Behavioral: 11th grade reading level arthritis materials Behavioral: Interactive in-person arthritis education |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
| Official Title: | Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2002 |
Patients with poor literacy report worse health and know less about managing their disease than patients with better literacy. This study will compare the disease outcomes of arthritis patients at three different reading levels who receive either standard arthritis materials written at an 11th grade reading level or an in-person, interactive, text-free session along with lower reading level materials. The study will determine the most effective methods of educating patients with poor literacy about their disease.
Patients with systemic inflammatory rheumatic conditions (rheumatoid arthritis, psoriatic arthritis, and seronegative polyarthritis) will be assessed and placed into one of three reading levels: 8th grade or lower; 9th to 11th grade; or 12th grade or higher. Patients from each reading level will be randomly assigned to one of two intervention groups. Group 1 will receive disease-specific material from the Arthritis Foundation written at an 11th grade reading level. Group 2 will receive plain language materials, an arthritis glossary, and a one-hour, in-person session with a study educator using interactive, text-free methods. The study educator will help the patient with reading-related problems either by study visit or by telephone for 6 months postsession.
All patients will receive a medication calendar. Patients will be followed for one year after the intervention and will be assessed for changes in health status, disease activity, communication with the physician, self-management of their arthritis, understanding of and adherence to prescribed treatment, and satisfaction with their intervention.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Matthew H. Liang, MD, MPH | Brigham and Women's Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00023205 History of Changes |
| Other Study ID Numbers: | P60 AR47782 NIAMS-068 |
| Study First Received: | August 29, 2001 |
| Last Updated: | April 26, 2007 |
| Health Authority: | United States: Federal Government |
|
Arthritis Health literacy Patient education Self-efficacy |
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |