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Impact of Literacy Level on Patient Education and Health Among People With Arthritis

Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00023205
Enrollment
134
Registered
2001-08-31
Start date
2002-11-30
Completion date
2006-12-31
Last updated
2013-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyarthritis, Psoriatic Arthritis, Rheumatoid Arthritis

Keywords

Arthritis, Health literacy, Patient education, Self-efficacy

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORAL11th grade reading level arthritis materials
BEHAVIORALInteractive in-person arthritis education

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction with medical care6 months and 12 monthsself report of satisfaction
Adherence to treatment6 months, 12 monthsself report of medication use on standard form
Self efficacy6 months and 12 monthsself report on self efficacy form

Secondary

MeasureTime frameDescription
Understanding of medication6 months and 12 monthsopen ended questionnaire of medication purpose
Appointment keeping6 and 12 monthsClinical record
Perceived usefulness of materials6months and 12 monthsInterview
Heath Status6 months and 12 monthsHealth Assessment questionaire
Mental Health6 months and 12 monthsSF-36 (5 items)

Other

MeasureTime frameDescription
Literacy-related problems encountered in management6 months and 12 monthsInterview

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026