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临床试验/NCT01941433
NCT01941433已完成不适用

Proof of Concept Study of the Arthritis Health Journal, a Patient Passport for Rheumatoid Arthritis

University of British Columbia2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
Self-Management Behaviours

研究概览

简要总结

The purpose of this study is to determine whether an online patient passport tool called the Arthritis Health Journal can assist people with rheumatoid arthritis in managing their disease.

详细描述

Patient passports have been developed and used in chronic diseases, such as diabetes, to promote active involvement of patients in their care, and have led to better treatment and health outcomes. In rheumatoid arthritis (RA), active involvement of patients in monitoring their symptoms and their disease activity may facilitate treatment according to current recommendations, which emphasize the need for aggressive treatment to suppress inflammation and for using a "Treat to Target" approach where treatment is escalated until a target is reached and is promptly modified when target is no longer met. In this study, the investigators have developed an online tool that aims to help people with RA monitor their symptoms and their disease activity and self-manage their arthritis. The investigators will perform a proof of concept study assessing how the Arthritis Health Journal affects consumer effectiveness, patient self-efficacy, communication with health professionals, shared decision-making, and satisfaction with medical care. The investigators will also evaluate the feasibility and satisfaction with using the Arthritis Health Journal. The investigators will use a stepped wedge study design, in which 50 participants will be randomized to either the intervention group (immediate use of the Arthritis Health Journal) or the control group (waitlisted for 6 months). Due to the nature of the intervention, the study is not blinded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Be 18 years of age or older
  • Have a diagnosis of rheumatoid arthritis
  • Be under the ongoing care of a rheumatologist
  • Be comfortable using a computer and online applications
  • Have access to an Internet connection
  • Be able to read and write English without needing a translator

排除标准

  • Younger than 18 years of age;
  • Diagnoses of arthritis other than rheumatoid arthritis
  • not under the ongoing care of a rheumatologist
  • not comfortable using a computer
  • lack of Internet access
  • inability to read and write in English without a translator

研究组 & 干预措施

Arthritis Health Journal

Experimental

Participants in this group will use the Arthritis Health Journal in the first 6 months of study.

干预措施: Arthritis Health Journal (Behavioral)

Control

Other

Participants in this group will receive a delayed intervention. They will receive usual care for the first 6 months of study, during which time they will contribute control data, and they will use the Arthritis Health Journal in the second 6 months of study, during which time they will contribute intervention data.

干预措施: Arthritis Health Journal (Behavioral)

结局指标

主要结局

Self-Management Behaviours

时间窗: 6 months

We will use the overall score from the Partners in Health Scale, an 11 item questionnaire based on the principles of self-management, which measures people's ability to engage in behaviours for the self-management of a chronic disease.

次要结局

  • Consumer Effectiveness(6 months)
  • Self-Efficacy(6 months)
  • Patient Satisfaction with Care(6 months)
  • Self-Management Behaviours(6 months)

研究者

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

Diane Lacaille

Principal Investigator

University of British Columbia

研究点 (2)

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