E-learning in Patient Education to Patients With Rheumatoid Arthritis (WEB-RA)
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| ClinicalTrials.gov Identifier: NCT04669340 |
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Recruitment Status :
Recruiting
First Posted : December 16, 2020
Last Update Posted : April 4, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis Patient Involvement Self Efficacy | Other: E-learning patient education Other: Standard face-to-face patient education | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Masking Description: | Masking not possible due to mode of intervention. |
| Primary Purpose: | Health Services Research |
| Official Title: | E-learning in Patient Education to Patients With Rheumatoid Arthritis - An Evaluation of the Effectiveness, the Patient Perspective and the Implementation |
| Actual Study Start Date : | February 1, 2021 |
| Estimated Primary Completion Date : | September 1, 2023 |
| Estimated Study Completion Date : | December 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention group
Participants in the intervention group will receive patient education through an e-learning program at home. A study nurse will introduce patients to the program and they will be asked to accomplish the program within four weeks. Furthermore, they will be encouraged to go through the program as many times as necessary and involve family and relatives if they like. Both groups will receive one planned phone call regarding medication 2-3 weeks after they started taking the medicine. Furthermore, both groups will be referred to a physiotherapist if needed. All patients have access to contact the out-patient clinic as needed throughout the study period. |
Other: E-learning patient education
The intervention implies patient education through an e-learning program. The program consists of three learning modules covering knowledge of rheumatoid arthritis, medication, examinations, complications and daily living with RA. Module 1 consists of 'need to know' information about disease management, symptoms and medication. Thus, it is mandatory and must be completed before entering module 2 and 3. In module 2 and 3, patients can move around on the basis of their individual needs. The duration of the full program is approximately two hours, but may vary dependent on the individual user needs. The program may be used as much as needed throughout the study period. |
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Active Comparator: Control group
Participants in the control group will receive conventional patient education from a nurse in the out-patient clinic within four weeks after inclusion. Relatives can take part in the conversation. Both groups will receive one planned phone call regarding medication 2-3 weeks after they started taking the medicine. Furthermore, both groups will be referred to a physiotherapist if needed. All patients have access to contact the out-patient clinic as needed throughout the study period. |
Other: Standard face-to-face patient education
The intervention implies usual care, i.e. face-to-face patient education in a one-hour session with a nurse at the hospital. This form of patient education is based on the patients individual need for information and guidance in relation to rheumatoid arthritis and medication. Thus, aspects of daily life with the disease is discussed at the beginning and forms the conversation. However, as a standard, information of the disease, disease management, symptoms and medication must be discussed with the patient and relatives. |
- Change in self-efficacy from baseline after 1, 3, 6 and 12 months [ Time Frame: 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.
- Change in knowledge of RA from baseline after 1, 3, 6 and 12 months [ Time Frame: 1, 3, 6 and 12 months ]Knowledge of RA will be measured through the PKQ-RA (Patient knowledge questionnaire - Rheumatoid arthritis) questionnaire. Ahead of this study we have translated, validated and adapted this questionnaire into a Danish Version reflecting the content of our e-learning program and updated this to reflect current treatment guidelines.
- Change in compliance from baseline after 1, 3, 6 and 12 months [ Time Frame: 1, 3, 6 and 12 months ]The 5 item compliance questionnaire (CQR5) will be used to measure patients adherence to medication.
- Change in health literacy from baseline after 1, 3, 6 and 12 month [ Time Frame: 1, 3, 6 and 12 months ]Parts of the health literacy questionnaire (HLQ) will be used. A set of abilities, such as reading and acting upon written health information, communicating needs to health professionals, and understanding health instructions is measured through this instrument.
- Change in health-related quality of life from baseline after 1, 3, 6 and 12 months [ Time Frame: 1, 3, 6 and 12 months ]Quality of life will be measured through the EQ-5D (European Quality of Life - 5 Dimensions) questionnaire which covers mobility, personal care, usual activities, pain, anxiety and depression.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669340
| Contact: Line R Knudsen, RN, MCN | +45 30375716 | linknuds@rm.dk | |
| Contact: Annette de Thurah, MPH, PhD | annethur@rm.dk |
| Denmark | |
| Aalborg University Hospital | Recruiting |
| Aalborg, Denmark, 9000 | |
| Contact: Line Raunsbæk Knudsen +45 30375716 linknuds@rm.dk | |
| Aarhus University Hospital | Recruiting |
| Aarhus N, Denmark, 8200 | |
| Contact: Line Raunsbæk Knudsen 78451927 linknuds@rm.dk | |
| Hjørring Regional Hospital | Recruiting |
| Hjørring, Denmark, 8355 | |
| Contact: Line Raunsbæk Knudsen +45 30375716 linknuds@rm.dk | |
| Horsens Hospital | Recruiting |
| Horsens, Denmark, 8700 | |
| Contact: Line Raunsbæk Knudsen +45 30375716 linknuds@rm.dk | |
| Randers Regional Hospital | Recruiting |
| Randers, Denmark, 8930 | |
| Contact: Line Raunsbæk Knudsen +45 30375716 linknuds@rm.dk | |
| Principal Investigator: | Line R Knudsen, RN, MCN | Aarhus University Hospital and Aarhus University |
Documents provided by Line Raunsbæk Knudsen, Aarhus University Hospital:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Line Raunsbæk Knudsen, Nurse, PhD student, Aarhus University Hospital |
| ClinicalTrials.gov Identifier: | NCT04669340 |
| Other Study ID Numbers: |
1-16-02-52-19 |
| First Posted: | December 16, 2020 Key Record Dates |
| Last Update Posted: | April 4, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We intend to publish the study protocol in an international peer reviewed journal. |
| Supporting Materials: |
Study Protocol |
| Time Frame: | At the beginning of 2021. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Patient education Self-management Technology E-learning |
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |