Rheumatoid ArthritisWEB-RANCT04669340
E-learning in Patient Education to Patients With Rheumatoid Arthritis
A study testing E-learning patient education and Standard face-to-face patient education in people with Rheumatoid Arthritis and Patient Involvement, run by Aarhus University Hospital at 5 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Patient Involvement, Self Efficacy
- What is being tested?
- E-learning patient education and Standard face-to-face patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Feb 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus University Hospital
Aarhus N, 8200
Hjørring Regional Hospital
Hjørring, 8355
Horsens Hospital
Horsens, 8700
Randers Regional Hospital
Randers, 8930
About this study
Official title: E-learning in Patient Education to Patients With Rheumatoid Arthritis - An Evaluation of the Effectiveness, the Patient Perspective and the Implementation
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.
Read more
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.
- Conditions
- Rheumatoid Arthritis, Patient Involvement, Self Efficacy
- Being tested
- E-learning patient education, Standard face-to-face patient education
- Keywords
- Patient education, Self-management, Technology, E-learning
- Medical subject headings
- Arthritis, Rheumatoid, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learning patient educationOther
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.
Standard face-to-face patient educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: E-learning patient education |
| Control group | Active comparator | 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. Receives: Other: Standard face-to-face patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy from baseline after 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.
Measured: 1, 3, 6 and 12 months
Secondary outcomes (4)
Change in knowledge of RA from baseline after 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.
Measured: 1, 3, 6 and 12 months
Change in compliance from baseline after 1, 3, 6 and 12 months
The 5 item compliance questionnaire (CQR5) will be used to measure patients adherence to medication.
Measured: 1, 3, 6 and 12 months
Change in health literacy from baseline after 1, 3, 6 and 12 month
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.
Measured: 1, 3, 6 and 12 months
Change in health-related quality of life from baseline after 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.
Measured: 1, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Feb 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital, Aalborg University Hospital, Horsens Hospital, TrygFonden, Denmark, Novo Nordisk A/S, Regionshospital Nordjylland
- Responsible party
- Principal investigator, Line Raunsbæk Knudsen, Aarhus University Hospital
- Investigators
- Line R Knudsen, RN, MCN, Principal investigator, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669340
- Sponsor's protocol ID
- 1-16-02-52-19
- Acronym
- WEB-RA
- Status last verified
- Jul 2024
- First submitted
- 27 Nov 2020
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to publish the study protocol in an international peer reviewed journal.
Publications
Brady TJ, Murphy L, O'Colmain BJ, Beauchesne D, Daniels B, Greenberg M, House M, Chervin D. A meta-analysis of health status, health behaviors, and health care utilization outcomes of the Chronic Disease Self-Management Program. Prev Chronic Dis. 2013;10:120112. doi: 10.5888/pcd10.120112.
PubMed 23327828Zangi HA, Ndosi M, Adams J, Andersen L, Bode C, Bostrom C, van Eijk-Hustings Y, Gossec L, Korandova J, Mendes G, Niedermann K, Primdahl J, Stoffer M, Voshaar M, van Tubergen A; European League Against Rheumatism (EULAR). EULAR recommendations for patient education for people with inflammatory arthritis. Ann Rheum Dis. 2015 Jun;74(6):954-62. doi: 10.1136/annrheumdis-2014-206807. Epub 2015 Mar 3.
PubMed 25735643Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, Williams B, Gabriel S, Lassere M, Johns N, Buchbinder R, Woolf A, March L. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1316-22. doi: 10.1136/annrheumdis-2013-204627. Epub 2014 Feb 18.
PubMed 24550173Minichiello E, Semerano L, Boissier MC. Time trends in the incidence, prevalence, and severity of rheumatoid arthritis: A systematic literature review. Joint Bone Spine. 2016 Dec;83(6):625-630. doi: 10.1016/j.jbspin.2016.07.007. Epub 2016 Sep 5.
PubMed 27616690Bech B, Primdahl J, van Tubergen A, Voshaar M, Zangi HA, Barbosa L, Bostrom C, Boteva B, Carubbi F, Fayet F, Ferreira RJO, Hoeper K, Kocher A, Kukkurainen ML, Lion V, Minnock P, Moretti A, Ndosi M, Pavic Nikolic M, Schirmer M, Smucrova H, de la Torre-Aboki J, Waite-Jones J, van Eijk-Hustings Y. 2018 update of the EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. Ann Rheum Dis. 2020 Jan;79(1):61-68. doi: 10.1136/annrheumdis-2019-215458. Epub 2019 Jul 12.
PubMed 31300458Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
PubMed 12867348Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
PubMed 11606875Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
PubMed 10413387Holman H LK. Perceived self-efficacy in self-management of chronic disease. In: Schwarzer R, editor. Self-efficacy: Thought Control of Action. 1st ed. London: Taylor & Francis; 1994: 305-21
Bandura A. Exercise of personal agency through the self-efficacy mechanism. In: Schwarzer R, editor. Self-efficacy: thought control of action. London: Taylor & Francis; 1994 (1st Ed.): 3-38.
Conner M, Norman P. Predicting health behavior: Research and practice with social cognition models. Open University Press. New York. 2005
Leventhal H, Brissette I, Leventhal EA. The common-sense model of self-regulation of health and illness. In: Cameron L.D., Leventhal H (Ed.). The self-regulation of health and illness behavior. Routledge. London. 2003.
Leventhal H, Phillips LA, Burns E. The Common-Sense Model of Self-Regulation (CSM): a dynamic framework for understanding illness self-management. J Behav Med. 2016 Dec;39(6):935-946. doi: 10.1007/s10865-016-9782-2. Epub 2016 Aug 11.
PubMed 27515801Shigaki CL, Smarr KL, Siva C, Ge B, Musser D, Johnson R. RAHelp: an online intervention for individuals with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1573-81. doi: 10.1002/acr.22042.
PubMed 23666599Lorig KR, Ritter PL, Laurent DD, Plant K. The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheum. 2008 Jul 15;59(7):1009-17. doi: 10.1002/art.23817.
PubMed 18576310
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-learning in Patient Education to Patients With Rheumatoid Arthritis - An Evaluation of the Effectiveness, the Patient Perspective and the Implementation
- ClinicalTrials.gov ID
- NCT04669340
- Acronym / sponsor ID
- WEB-RA / 1-16-02-52-19
- Conditions
- Rheumatoid Arthritis, Patient Involvement, Self Efficacy
- Keywords
- Patient education, Self-management, Technology, E-learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Randers Regional Hospital, Aalborg University Hospital, Horsens Hospital, TrygFonden, Denmark, Novo Nordisk A/S, Regionshospital Nordjylland
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: E-learning patient educationParticipants 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. |
| Control group | Active comparator | Other: Standard face-to-face patient educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learning patient educationThe 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. | Other | Intervention group |
| Standard face-to-face patient educationThe 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. | Other | Control group |
Primary outcome
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.
4 secondary outcomes
Change in knowledge of RA from baseline after 1, 3, 6 and 12 months
Time frame: 1, 3, 6 and 12 months
Change in compliance from baseline after 1, 3, 6 and 12 months
Time frame: 1, 3, 6 and 12 months
Change in health literacy from baseline after 1, 3, 6 and 12 month
Time frame: 1, 3, 6 and 12 months
Change in health-related quality of life from baseline after 1, 3, 6 and 12 months
Time frame: 1, 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 23327828Brady TJ, Murphy L, O'Colmain BJ, Beauchesne D, Daniels B, Greenberg M, House M, Chervin D. A meta-analysis of health status, health behaviors, and health care utilization outcomes of the Chronic Disease Self-Management Program. Prev Chronic Dis. 2013;10:120112. doi: 10.5888/pcd10.120112.
- Background: PubMed 25735643Zangi HA, Ndosi M, Adams J, Andersen L, Bode C, Bostrom C, van Eijk-Hustings Y, Gossec L, Korandova J, Mendes G, Niedermann K, Primdahl J, Stoffer M, Voshaar M, van Tubergen A; European League Against Rheumatism (EULAR). EULAR recommendations for patient education for people with inflammatory arthritis. Ann Rheum Dis. 2015 Jun;74(6):954-62. doi: 10.1136/annrheumdis-2014-206807. Epub 2015 Mar 3.
- Background: PubMed 24550173Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, Williams B, Gabriel S, Lassere M, Johns N, Buchbinder R, Woolf A, March L. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1316-22. doi: 10.1136/annrheumdis-2013-204627. Epub 2014 Feb 18.
- Background: PubMed 27616690Minichiello E, Semerano L, Boissier MC. Time trends in the incidence, prevalence, and severity of rheumatoid arthritis: A systematic literature review. Joint Bone Spine. 2016 Dec;83(6):625-630. doi: 10.1016/j.jbspin.2016.07.007. Epub 2016 Sep 5.
- Background: PubMed 31300458Bech B, Primdahl J, van Tubergen A, Voshaar M, Zangi HA, Barbosa L, Bostrom C, Boteva B, Carubbi F, Fayet F, Ferreira RJO, Hoeper K, Kocher A, Kukkurainen ML, Lion V, Minnock P, Moretti A, Ndosi M, Pavic Nikolic M, Schirmer M, Smucrova H, de la Torre-Aboki J, Waite-Jones J, van Eijk-Hustings Y. 2018 update of the EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis. Ann Rheum Dis. 2020 Jan;79(1):61-68. doi: 10.1136/annrheumdis-2019-215458. Epub 2019 Jul 12.
- Background: PubMed 12867348Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
- Background: PubMed 11606875Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
- Background: PubMed 10413387Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
- BackgroundHolman H LK. Perceived self-efficacy in self-management of chronic disease. In: Schwarzer R, editor. Self-efficacy: Thought Control of Action. 1st ed. London: Taylor & Francis; 1994: 305-21
- BackgroundBandura A. Exercise of personal agency through the self-efficacy mechanism. In: Schwarzer R, editor. Self-efficacy: thought control of action. London: Taylor & Francis; 1994 (1st Ed.): 3-38.
- BackgroundConner M, Norman P. Predicting health behavior: Research and practice with social cognition models. Open University Press. New York. 2005
- BackgroundLeventhal H, Brissette I, Leventhal EA. The common-sense model of self-regulation of health and illness. In: Cameron L.D., Leventhal H (Ed.). The self-regulation of health and illness behavior. Routledge. London. 2003.
- Statistics - The use of Internet in the Danish populationLink provided by the sponsor.
- Ten Attributes of Health Literate Health Care Organizations. Institute of Medicine - Of the national academiesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We intend to publish the study protocol in an international peer reviewed journal.
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Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line R Knudsen, RN, MCN principal investigator
Aarhus University Hospital and Aarhus University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning patient education and Standard face-to-face patient education in people with Rheumatoid Arthritis and Patient Involvement, run by Aarhus University Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-efficacy from baseline after 1, 3, 6 and 12 months (time frame: 1, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669340, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.