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Showing 1-20 of 28 trials
NCT06550024
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
NCT07469787
The transition from pediatric to adult care is a critical period for young people with chronic inflammatory rheumatic diseases (CIRD) and is associated with risks of poor self-management, loss to follow-up, and disease worsening. Although structured transition programs have been recommended, real-world data on their effectiveness in rheumatology remain limited. Since 2018, a structured transition program has been implemented at Bicêtre University Hospital (AP-HP, France), combining early transition preparation, a therapeutic patient education (TPE) workshop, and a joint pediatric-adult transition consultation. Some patients benefit from both components, while others receive a transition consultation only. The BOOST-R study is a monocentric, non-interventional observational study designed to evaluate the impact of different transition modalities on self-management after transfer to adult care. The primary objective is to compare transition readiness, assessed using the validated French version of the Transition Readiness Assessment Questionnaire (TRAQ-FR), between patients who received a TPE workshop plus a transition consultation and those who received a transition consultation only. Secondary objectives include evaluating continuity of care after transition, identifying factors associated with successful transition, assessing the contribution of the RESRIP support network, and describing patients who did not benefit from structured transition support.
NCT04402086
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.
NCT05443321
Sub-optimal transfer of clinical information during inter-hospital transfer (IHT, the transfer of patients between acute care hospitals) is common and can lead to patient harm. To address this problem, the investigators will use key stakeholder input to refine and implement an interoperable health information exchange platform that integrates with the electronic health record and improves the reliability of and access to necessary clinical information in three use cases involving transfer of patients between sending and receiving hospitals with varying levels of affiliation and health record integration. The investigators will assess the effect of this intervention on frequency of medical errors, evaluate the use and usability of this platform from the perspective of those that interact with it, and use these results to develop a dissemination plan to spread implementation and use of this platform across other similar institutions.
NCT05516758
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
NCT06591949
Cognitive Exercise Therapy Approach (\*Bilişsel Egzersiz Terapi Yaklaşımı\*-BETY), an innovative method developed for adults with rheumatism, aims to promote behavioral change and prevent social isolation by focusing on exercises that provide pain management and functional gains. BETY also recognizes the importance of family education in achieving these goals. However, there is a need for studies on exercise approaches that fit the biopsychosocial model, such as BETY in childhood rheumatic diseases. BETY is an innovative exercise approach based on the biopsychosocial model that aims to change the patient's cognitions through exercise, specifically developed for patients with rheumatism. This approach includes function-oriented trunk stabilization exercises, chronic pain management, and authentic dance therapy training targeting positive cognitive displacement. It is carried out in a routinized structure that continues for years on a face-to-face basis in groups and individually. Interventions that provide physical and psychosocial support are needed in childhood rheumatic diseases. Learning to exercise the muscles surrounding the joints at the proper traction angle through exercise with BETY, gaining the ability to manage chronic pain during the day, gaining positive cognitive displacement skills, and having the opportunity to socialize through both individual and group exercises constitute the basis of the intervention.
NCT06018350
The investigators will pilot test a clinician-led intervention to improve medication adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study will assess feasibility, acceptability, and fidelity, and explore signal for improved medication adherence.
NCT05786235
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.
NCT04890483
Some patients develop "Post-acute COVID-19 syndrome," in which they experience persistent symptoms after recovering from the acute phase of COVID-19 infection. This syndrome may be more significant in patients with systemic autoimmune rheumatic diseases (SARDs) who have been suffering from several symptoms associated to SARDs, such as myalgia, fatigue, and general pains. The transcranial direct current stimulation (tDCS) technique has been frequent, for example, to relieve fatigue and general pains in general population. However, to date, there are no studies evaluating this technique in ARD patients with post-acute COVID-19; therefore, the main objective of the opened study is to evaluate the safety and efficacy of the application of acute tDCS in ARD patients with post-acute COVID-19.
NCT04310462
Hydroxychloroquine (HCQ) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. Although generally well tolerated, study data have demonstrated that long-term use of HCQ may lead to irreversible and potentially vision-threatening retinal toxicity. The American Academy of Ophthalmology (AAO) issued guidelines in 2011, and again in 2016 that recommended dosing of HCQ be based on an individual's body weight, and also outlined how and when to screen for retinal toxicity. While clinicians have been aware of the potential side effects of HCQ for decades, studies have shown that many patients continue to receive higher than recommended doses. The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). The investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines by randomizing clinicians to the new interface. Ideally, the eRX interface will result in a lower number of potential adverse events (i.e. retinal toxicity) associated with high-dose, long-term use of HCQ.
NCT06385574
Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life.
NCT04879745
This is a pilot trial to assess feasibility and acceptability of MyVoice:Rheum vs. a patient pamphlet among female patients ages 18-44 (n=40) who receive rheumatology care. • Hypothesis: MyVoice:Rheum will be feasible and acceptable to patients who receive rheumatology care.
NCT06226792
The goal of this observational study is to determine whether there is a decrease in muscle mass and the relationship between lower extremity skeletal muscle mass, muscle strength and disease activity in Ankylosing spondylitis. The main questions it aims to answer are: * Is there a relationship between the muscle thickness and pennation angle of the quadriceps, Gastrocnemius medialis and lateralis, Vastus medialis and lateralis and tibialis anterior muscles with disease activity and muscle strength? * Are there any differences in the results of morphological parameters of lower extremity muscles between Ankylosing spondylitis and voluntary participants? Researchers will compare voluntary participants to see if any difference in lower muscle morphological parameters.
NCT05402358
Does a group programme already delivered in routine practice to patients who share a diagnosis from the same medical speciality (i.e. specific-diagnosis) show equal effectiveness when modified for patients with diagnoses from a range of medical specialities (i.e. mixed-diagnosis)? A large number of people live with a long-term condition (LTC) and the burden of living with a LTC is recognised on a societal and individual level. Links between LTCs and poorer mental health increase demand on psychological services. Consequently new initiatives try to reduce waiting times and increase the capacity of these services. Group programmes use resources efficiently and have been applied across a range of medical specialities. A clinical health psychology service has adopted a group programme based on a well evidenced psychological therapeutic approach called Acceptance and Commitment Therapy (ACT), for patients with dermatology conditions showing promising outcomes. However, the investigators want to compare whether similar outcomes can be achieved with patients from a range of specialities. The investigators conducted quantitative and qualitative research to answer the research questions a) Does an Acceptance and Commitment Therapy group intervention for specific-diagnosis groups suggest similar effectiveness in health-related quality of life, illness beliefs and psychological distress versus mixed-diagnosis groups? b) Is there a difference in feasibility and acceptability of an Acceptance and Commitment Therapy intervention between specific-diagnosis groups versus mixed-diagnosis groups? c) What are health professionals' views on the acceptability and feasibility of specific-diagnosis versus mixed-diagnosis groups and their experiences of working with patients who have attended such groups? Participants were recruited from the Clinical Health Psychology waiting list at a UK NHS Trust. Participants attended 7, two-hour weekly sessions and an 8 week follow-up 'reunion', and completed health related quality of life, illness perceptions, depression and anxiety questionnaires pre and post intervention. Patient participants and health professional participants (facilitators and referrers) were invited to attend focus groups to discuss their views and experiences.
NCT05666115
Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. The clinical management of axSpA needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life. The aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. This will be the first randomized controlled trial where probiotics are compared with an active intervention.
NCT05698251
The goal of this pilot intervention study is to develop and test a new psychological therapy model in people with long term health conditions (rheumatic conditions) who are experiencing distress (anxiety or low mood) in relation to the uncertainty that their illness causes. The main questions the study aims to answer are: 1. Does the new treatment model help participants reduce uncertainty distress associated with their health condition? 2. Is it a practical treatment that can be ran within a hospital setting? 3. Is the treatment acceptable to participants? Participants will be asked to attend weekly therapy sessions (up to a maximum of 16 sessions) in the hospital or via telehealth. The sessions will be based on the new treatment model and aimed at helping participants reduce uncertainty where they can and learn to live alongside it where it cannot be reduced. The hope is that if participants can better manage uncertainty this will reduce the distress (anxiety or low mood) that they feel.
NCT04568421
SAR-COVID is a national, multicenter, prospective, observational longitudinal registry of consecutive patients with diagnosis of rheumatic diseases treated or not with immunomodulatory and/or immunosuppressive drugs and SARS-CoV-2 infection (asymptomatic or COVID-19). Hypothesis: Patients with rheumatic diseases who are under chronic treatment with immunomodulatory and/or immunosuppressive drugs more frequently have an asymptomatic infection, a milder COVID-19 and lower mortality than patients with rheumatic diseases without immunomodulatory and/or immunosuppressive treatments.
NCT05554029
COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). The most common symptoms are fever, cough and dyspnoea. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine.
NCT05007340
A complex interaction between demographic, environmental and genetic mechanisms impact the onset, severity and outcome of ILD-SARDs through dysregulation of the immune system and lung pro-biotic pathways. Comorbidity and genetic risk indicate that there are overlapping pathogenic mechanisms among SARDs, some of which underlie ILD in different SARDs. The purpose of this biobank is to study the clinical, pathological, laboratory, and imaging characteristics of SARDs patients with lung involvement. This will help identify as unique features underlying lung involvement in SARDs. In addition, this may lead to the discovery of novel mechanisms of disease and potentially novel targets of treatment for SARDs patients with lung disease.
NCT04187794
A medication non-adherence is reported in chronic rheumatic diseases, in a context of complex and long-term treatments (injectable/per os targeted therapies, biosimilar...). Understanding and integrating the patient into a shared medical decision are key factors for adherence. From this perspective, the level of literacy (an individual's ability to find, understand and use health information) must be explored in order to adapt the communication of information. These are currently insufficiently adapted to the individual understanding of patients. In practice, literacy assessment is very poorly integrated into routine care, while several tools are validated in French. In rheumatology, foreign studies have shown that literacy is positively related to knowledge level. The results remain contradictory regarding its association with medication adherence. Today, the literacy level of patients with rheumatic diseases and its impact on adherence has not been studied in France, although these evaluations would be useful to adapt interventions individually. The acceptance of patients to complete a literacy assessment questionnaire during their care should also be analysed as a condition of its deployment.