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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023205
• Other study ID #: P60 AR47782 NIAMS-068
• Secondary ID: P60AR047782
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2001
• Last updated: December 23, 2013
• Start date: November 2002
• Est. completion date: December 2006

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Polyarthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis

Intervention

Behavioral:
• 11th grade reading level arthritis materials

• Interactive in-person arthritis education

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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