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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00023205
First received: August 29, 2001
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Adherence to treatment [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    self report of medication use on standard form

  • Self efficacy [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    self report on self efficacy form

  • Satisfaction with medical care [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    self report of satisfaction


Secondary Outcome Measures:
  • Heath Status [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Health Assessment questionaire

  • Mental Health [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    SF-36 (5 items)

  • Understanding of medication [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    open ended questionnaire of medication purpose

  • Perceived usefulness of materials [ Time Frame: 6months and 12 months ] [ Designated as safety issue: No ]
    Interview

  • Appointment keeping [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Clinical record


Other Outcome Measures:
  • Literacy-related problems encountered in management [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Interview


Enrollment: 134
Study Start Date: November 2002
Study Completion Date: December 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023205

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Matthew H. Liang, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00023205     History of Changes
Other Study ID Numbers: P60 AR47782 NIAMS-068, P60AR047782
Study First Received: August 29, 2001
Last Updated: December 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Arthritis
Health literacy
Patient education
Self-efficacy

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

ClinicalTrials.gov processed this record on October 23, 2014