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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Polyarthritis

Intervention / Treatment
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* Behavioral: 11th grade reading level arthritis materials
* Behavioral: Interactive in-person arthritis education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized education<br>Individualized education with materials written in plain language. Follow-up sessions/ phone contact as requested by the subject. | Behavioral: Interactive in-person arthritis education<br> <br> |
| Active Comparator: Standard care<br>1 session of education with provision of standard Arthritis Foundation materials. | Behavioral: 11th grade reading level arthritis materials<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heath Status | Health Assessment questionaire | 6 months and 12 months | 
| Mental Health | SF-36 (5 items) | 6 months and 12 months | 
| Understanding of medication | open ended questionnaire of medication purpose | 6 months and 12 months | 
| Perceived usefulness of materials | Interview | 6months and 12 months | 
| Appointment keeping | Clinical record | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Health literacy, Patient education, Self-efficacy