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临床试验/NCT00023205
NCT00023205已完成2 期

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2002年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
134
试验地点
2
主要终点
Adherence to treatment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Adherence to treatment

时间窗: 6 months, 12 months

self report of medication use on standard form

Self efficacy

时间窗: 6 months and 12 months

self report on self efficacy form

Satisfaction with medical care

时间窗: 6 months and 12 months

self report of satisfaction

次要结局

  • Perceived usefulness of materials(6months and 12 months)
  • Mental Health(6 months and 12 months)
  • Heath Status(6 months and 12 months)
  • Understanding of medication(6 months and 12 months)
  • Appointment keeping(6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew H. Liang, MD

Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

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