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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)


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
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