Clinical trial NCT04669340: E-learning in Patient Education to Patients With Rheumatoid Arthritis
Official title: E-learning in Patient Education to Patients With Rheumatoid Arthritis - An Evaluation of the Effectiveness, the Patient Perspective and the Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Patient Involvement
Self Efficacy
Keywords: Patient education
Self-management
Technology
E-learning
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
name: Aalborg University Hospital
name: Horsens Hospital
name: TrygFonden, Denmark
name: Novo Nordisk A/S
name: Regionshospital Nordjylland
First posted: 2020-12-16
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change in self-efficacy from baseline after 1, 3, 6 and 12 months
timeFrame: 1, 3, 6 and 12 months
Secondary outcomes:
measure: Change in knowledge of RA from baseline after 1, 3, 6 and 12 months
timeFrame: 1, 3, 6 and 12 months
measure: Change in compliance from baseline after 1, 3, 6 and 12 months
timeFrame: 1, 3, 6 and 12 months
measure: Change in health literacy from baseline after 1, 3, 6 and 12 month
timeFrame: 1, 3, 6 and 12 months
measure: Change in health-related quality of life from baseline after 1, 3, 6 and 12 months
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Hjørring
country: Denmark
facility: Hjørring Regional Hospital
city: Horsens
country: Denmark
facility: Horsens Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Line R Knudsen, RN, MCN
role: PRINCIPAL_INVESTIGATOR
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