Raunsbæk Knudsen, Line http://orcid.org/0000-0002-3176-6207
Lomborg, Kirsten
Ndosi, Mwidimi
Hauge, Ellen-Margrethe
de Thurah, Annette
Clinical trials referenced in this document:
Documents that mention this clinical trial
The effectiveness of e-learning in patient education delivered to patients with rheumatoid arthritis: The WebRA study—protocol for a pragmatic randomised controlled trial
https://doi.org/10.1186/s41927-021-00226-y
Funding for this research was provided by:
trygfonden (149582)
Article History
Received: 31 July 2021
Accepted: 24 August 2021
First Online: 20 December 2021
Declarations
:
: The study will be conducted in accordance with the Declaration of Helsinki. The Central Denmark Region Scientific Committee approved the study (No. 1-16-02-52-19). According to Danish Law and the Central Denmark Region Committee of Health Research Ethics, this study does not require ethical approval. A data processing agreement with the hosting company of the e-learning program has been composed and approved by the Technology Transfer Office at Aarhus University. Eligible patients will be given written information about the study described in lay language, along with verbal information in connection with a consultation in the outpatient clinic. A study nurse will provide an exhaustive survey of the written information, and patients will be given time for deliberation to ensure sufficient time to consider their potential involvement. Patients will be contacted within 1 week to discuss their possible participation in the study; however, if the need for deliberation is rejected, they may be enrolled immediately. In addition to the specific study information, patients will be given leaflets from the National Committee on Health Research Ethics about their rights as participants in a clinical trial. Eligible patients will be informed that participation is voluntary, withdrawal is possible at any time without consequences for their care and treatment, and their confidentiality and anonymity will be ensured. Written consent will be obtained from study participants before enrolment. In our view, there are no risks associated with participation in the study, and patients who reject participation will receive usual care—that is, standard patient education or information related to RA as usual provided in the rheumatology clinics.
: Not applicable.
: The authors declare that they have no competing interests.