Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in… (NCT05762185) | Clinical Trial Compass
CompletedNot Applicable
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
France71 participantsStarted 2019-11-06
Plain-language summary
Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
* Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion
* Major patient
* Patient having signed an informed consent
Exclusion Criteria:
* Minor patient
* Patient with cognitive impairment diagnosed by a physician
* Patient under tutorship or curatorship
* Patient deaf or hard of hearing
* Patient not fluent in the French language (at the decision of the investigator)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used something called the BIOSECURE score to measure patient confidence with self-injecting biotherapy — can you explain what that score measures and whether my current level of confidence with self-injection would have been relevant to a study like this?
2Since this trial has already completed, have the results shown that a dedicated nurse consultation actually made a meaningful difference in how safely and confidently patients managed their own subcutaneous injections at home?
3I'm currently on or being considered for a subcutaneous biotherapy for my rheumatoid arthritis — does our clinic already offer a structured nurse education consultation similar to what was studied here, or is that something I'd need to specifically ask for?
4This study focused on patient empowerment in managing self-injected biotherapy, which makes me think about my own readiness — what training or support would you recommend for me before I start injecting at home, based on what research like this has found?
5Since this was a nursing intervention study rather than a drug trial, are there any findings from completed research like this that have changed how your team currently educates rheumatoid arthritis patients about their biotherapy injections?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation of BIOSECURE score between baseline and after nurse consultation