Impact of Literacy Level on Patient Education and Health Among People With Arthritis
Behavioral: 11th grade reading level arthritis materials
Behavioral: Interactive in-person arthritis education
|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|
- 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
- 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
- Literacy-related problems encountered in management [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]Interview
|Study Start Date:||November 2002|
|Study Completion Date:||December 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023205
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Matthew H. Liang, MD, MPH||Brigham and Women's Hospital|