NCT00023205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

August 29, 2001

Last Update Submit

December 23, 2013

Conditions

Rheumatoid ArthritisPsoriatic ArthritisPolyarthritis

Keywords

ArthritisHealth literacyPatient educationSelf-efficacy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Heath Status

    6 months and 12 months

  • Mental Health

    6 months and 12 months

  • Understanding of medication

    6 months and 12 months

  • Perceived usefulness of materials

    6months and 12 months

  • Appointment keeping

    6 and 12 months

Other Outcomes (1)

  • Literacy-related problems encountered in management

    6 months and 12 months

Study Arms (2)

Individualized education

EXPERIMENTAL

Individualized education with materials written in plain language. Follow-up sessions/ phone contact as requested by the subject.

Behavioral: Interactive in-person arthritis education

Standard care

ACTIVE COMPARATOR

1 session of education with provision of standard Arthritis Foundation materials.

Behavioral: 11th grade reading level arthritis materials

Interventions

11th grade reading level arthritis materialsBEHAVIORAL
Standard care
Interactive in-person arthritis educationBEHAVIORAL
Individualized education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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.

    PMID: 1580173BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, PsoriaticArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Study Officials

  • Matthew H. Liang, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 29, 2001

First Posted

August 31, 2001

Study Start

November 1, 2002

Primary Completion

August 1, 2006

Study Completion

December 1, 2006

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

US(1)