Rheumatoid Arthritis Clinical Trial
Official title:
Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
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