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OpenTrials
Completed

NCT Number: NCT00023205

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

11th grade reading level arthritis materials

Behavioral

Interactive in-person arthritis education

Behavioral

Primary outcomes

  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 outcomes

  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

    Interview

  5. Appointment keeping

    Time frame: 6 and 12 months

    Clinical record

Other outcomes

  1. Literacy-related problems encountered in management

    Time frame: 6 months and 12 months

    Interview

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Aug 31, 2001
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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