Clinical trial NCT00023205: Impact of Literacy Level on Patient Education and Health Among People With Arthritis
Official title: Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Polyarthritis
Keywords: Arthritis
Health literacy
Patient education
Self-efficacy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2001-08-31
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to treatment
timeFrame: 6 months, 12 months
measure: Self efficacy
timeFrame: 6 months and 12 months
measure: Satisfaction with medical care
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: Heath Status
timeFrame: 6 months and 12 months
measure: Mental Health
timeFrame: 6 months and 12 months
measure: Understanding of medication
timeFrame: 6 months and 12 months
measure: Perceived usefulness of materials
timeFrame: 6months and 12 months
measure: Appointment keeping
timeFrame: 6 and 12 months
Other outcomes:
measure: Literacy-related problems encountered in management
timeFrame: 6 months and 12 months
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Matthew H. Liang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.