Impact of Literacy Level on Patient Education and Health Among People With Arthritis
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|ClinicalTrials.gov Identifier: NCT00023205|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : December 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Psoriatic Arthritis Polyarthritis||Behavioral: 11th grade reading level arthritis materials Behavioral: Interactive in-person arthritis education||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||December 2006|
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|
- Adherence to treatment [ Time Frame: 6 months, 12 months ]self report of medication use on standard form
- Self efficacy [ Time Frame: 6 months and 12 months ]self report on self efficacy form
- Satisfaction with medical care [ Time Frame: 6 months and 12 months ]self report of satisfaction
- Heath Status [ Time Frame: 6 months and 12 months ]Health Assessment questionaire
- Mental Health [ Time Frame: 6 months and 12 months ]SF-36 (5 items)
- Understanding of medication [ Time Frame: 6 months and 12 months ]open ended questionnaire of medication purpose
- Perceived usefulness of materials [ Time Frame: 6months and 12 months ]Interview
- Appointment keeping [ Time Frame: 6 and 12 months ]Clinical record
- Literacy-related problems encountered in management [ Time Frame: 6 months and 12 months ]Interview
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|