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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Polyarthritis
• Intervention / Treatment: Behavioral: Interactive in-person arthritis education; Behavioral: 11th grade reading level arthritis materials

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individualized education; Individualized education with materials written in plain language. Follow-up sessions/ phone contact as requested by the subject.	Behavioral: Interactive in-person arthritis education
Active Comparator: Standard care; 1 session of education with provision of standard Arthritis Foundation materials.	Behavioral: 11th grade reading level arthritis materials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to treatment	self report of medication use on standard form	6 months, 12 months
Self efficacy	self report on self efficacy form	6 months and 12 months
Satisfaction with medical care	self report of satisfaction	6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heath Status	Health Assessment questionaire	6 months and 12 months
Mental Health	SF-36 (5 items)	6 months and 12 months
Understanding of medication	open ended questionnaire of medication purpose	6 months and 12 months
Perceived usefulness of materials	Interview	6months and 12 months
Appointment keeping	Clinical record	6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Literacy-related problems encountered in management	Interview	6 months and 12 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: August 29, 2001
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Arthritis; Patient education; Self-efficacy; Health literacy
• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: P60 AR47782 NIAMS-068; P60AR047782 (U.S. NIH Grant/Contract)