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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023205
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : December 24, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Psoriatic Arthritis Polyarthritis Behavioral: 11th grade reading level arthritis materials Behavioral: Interactive in-person arthritis education Phase 2

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  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention
Study Start Date : November 2002
Actual Primary Completion Date : August 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

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

Primary Outcome Measures :
  1. Adherence to treatment [ Time Frame: 6 months, 12 months ]
    self report of medication use on standard form

  2. Self efficacy [ Time Frame: 6 months and 12 months ]
    self report on self efficacy form

  3. Satisfaction with medical care [ Time Frame: 6 months and 12 months ]
    self report of satisfaction

Secondary Outcome Measures :
  1. Heath Status [ Time Frame: 6 months and 12 months ]
    Health Assessment questionaire

  2. Mental Health [ Time Frame: 6 months and 12 months ]
    SF-36 (5 items)

  3. Understanding of medication [ Time Frame: 6 months and 12 months ]
    open ended questionnaire of medication purpose

  4. Perceived usefulness of materials [ Time Frame: 6months and 12 months ]

  5. Appointment keeping [ Time Frame: 6 and 12 months ]
    Clinical record

Other Outcome Measures:
  1. Literacy-related problems encountered in management [ Time Frame: 6 months and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023205

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital

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.

Responsible Party: Matthew H. Liang, MD, Professor of Medicine, Brigham and Women's Hospital Identifier: NCT00023205     History of Changes
Other Study ID Numbers: P60 AR47782 NIAMS-068
P60AR047782 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

Keywords provided by Matthew H. Liang, MD, Brigham and Women's Hospital:
Health literacy
Patient education

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases