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临床试验/NCT04669340
NCT04669340已完成不适用

E-learning in Patient Education to Patients With Rheumatoid Arthritis - An Evaluation of the Effectiveness, the Patient Perspective and the Implementation

Aarhus University Hospital10 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
181
试验地点
10
主要终点
Change in self-efficacy from baseline after 1, 3, 6 and 12 months

研究概览

简要总结

Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily causes pain, swelling and stiffness in the joints. The disease may reduce normal functioning and thereby quality of life.

Patient education (PE), with the aim of supporting patients to self-manage their disease is an important part of the treatment and care to patients with RA. PE supports people in living with RA by offering knowledge of the disease, symptoms and treatment as well as guidance in coping with the disease in everyday life. In recent years, the number of people with RA has risen and in general people lives longer. This places new demands on the healthcare system for alternatives to conventional care, e.g. through web technology and remote care.

Often PE is provided through face-to-face interactions with health professionals at the hospital and thus far, only a small number of studies have been conducted within the area of web-based PE targeting people with RA. A few studies within RA and other chronic diseases shows that online tools and online educational programs may enhance patient's knowledge of the disease and treatment and improve self-management and quality of life.

Internet and technology is a great part of everyday life, however, variation is seen in computer skills and likewise in health literacy skills.

Even so, PE based on web technology may have several advantages, e.g. the accessibility and the possibility to seek for information as needed and repeatedly in familiar surroundings and possibly with relatives.

Moreover, the integration of words and images can promote deeper understanding and learning since both auditory and visual channels are used. Possible disadvantages may be related to the absence of face-to-face contact with healthcare professionals.

Given the need for alternative solutions to the conventional face-to-face contact, the investigators have developed an e-learning program targeting newly diagnosed patients with RA. The purpose of the program is to support self-management of the disease. The program takes into consideration peoples different competencies and assumptions by presenting information in an easy, inspiring and entertaining way. The program consists of three learning modules covering knowledge of the disease, medication, examinations, complications and daily living with RA, e.g. coping with emotions, pain, fatigue, physical activity, work etc.

In keeping with different ways of learning and to support people's different competencies, the program offers a combination of animations, graphics, videos, podcasts, quizzes, written text and spoken words.

Given the limited evidence about the effectiveness of web-based PE in RA, the intention behind the study is to evaluate the e-learning program.

The project will be divided into three parts. In the first part the effect of the e-learning program will be evaluated. Approximately 200-230 patients from four rheumatology clinics in Denmark will be included. Half of the participants will receive education at home through the e-learning program and the other half will receive conventional education at the hospital.

The effect of PE will be evaluated through questionnaires covering self-efficacy, knowledge of RA and medication, medication taking, health literacy skills and quality of life. Additionally, disease activity, physical functioning, pain and fatigue will be measured.

Furthermore, the investigators will examine the use of the e-learning program, such as time consumption and completed modules. Finally, telephone contacts from patients to the outpatient clinics will be measured to investigate possible causal relationships between the information provided through PE and the need for additional information or guidance related to self-management. The number of out-patient visits in the clinic will also be measured.

In the second part the investigators will explore the perceptions of receiving PE through the e-learning program from the perspective of patients with RA. This will be explored through individually interviews with approximately 20-25 patients.

In the third part the complexities in the e-learning program to improve chances of success in implementation of the technology in clinical practice, i.e. outside the project, will be explored. Through focus group interviews with nurses and doctors involved in the project, the investigators will explore perspectives of using the program. The interviews will be based on a framework covering both successes, challenges and failures in relation to the technology, the patient group, values and the organisation.

Furthermore, the investigators will revisit the patient interviews from the second part in order to obtain information about these aspects from the patient perspective.

The investigators hypothesize that the e-learning PE program will be superior to standard face-to-face PE in improving self-efficacy.

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

盲法说明

Masking not possible due to mode of intervention.

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

  • Rheumatoid arthritis according to the American College of Rheumatology 2010 criteria within the past 3 - 4 months (before inclusion)
  • Able to speak and understand Danish
  • Able to access the Internet

排除标准

  • 未提供

结局指标

主要结局

Change in self-efficacy from baseline after 1, 3, 6 and 12 months

时间窗: 1, 3, 6 and 12 months

The primary outcome is the Danish version of the rheumatoid arthritis self-efficacy questionnaire (RASE). This is used as the primary outcome as self-efficacy is considered a pre-condition of self-management and as RASE is developed specifically for measuring self-efficacy in rheumatoid arthritis.

次要结局

  • Change in health literacy from baseline after 1, 3, 6 and 12 month(1, 3, 6 and 12 months)
  • Change in knowledge of RA from baseline after 1, 3, 6 and 12 months(1, 3, 6 and 12 months)
  • Change in compliance from baseline after 1, 3, 6 and 12 months(1, 3, 6 and 12 months)
  • Change in health-related quality of life from baseline after 1, 3, 6 and 12 months(1, 3, 6 and 12 months)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Line Raunsbæk Knudsen

Nurse, PhD student

Aarhus University Hospital

研究点 (10)

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