Arthritis, Rheumatoid Clinical Trial
Official title:
Wireless Motion Sensors for Rheumatoid Arthritis Patients - Pilot Study and Preliminary Validation Effort
This study aims to provide preliminary evidence of the validity of a sensor-based assessment of rheumatoid arthritis (RA) symptoms, and to collect structured qualitative feedback from RA Enbrel patients regarding the potential of a future biosensor/PRO mHealth application. The investigators' overarching hypothesis is that if patients have better and more timely information about whether Enbrel is working, then they will become more empowered and engaged in their treatment, more curious about how it may - or may not - be working, and potentially more compliant with therapy. However, this hypothesis remains largely untested.
Patients with rheumatoid arthritis (RA) often endure a remitting and flaring disease-course
characterized by considerable pain, stiffness, and fatigue. The social and emotional
well-being of RA patients can suffer as a result. Data demonstrate that adherence to Enbrel
significantly improves both functional status and health related quality of life (HRQOL) in
RA patients. Yet patients prescribed Enbrel often exhibit non-adherence through early
discontinuation, dose-stretching, and reduced persistence following medication "holidays".
The knowledge, attitudes, and beliefs held by patients with regard to RA and Enbrel
influence their perceptions of the benefits of, and barriers to, treatment.
Decisions to adhere occur when combined levels of susceptibility and severity provide the
motivation to act, and the perception of benefits (less barriers) indicates a path of
action. A given patient's ability to follow this path of action hinges on their relative
self-efficacy: the conviction that they can successfully execute a behavior required to
produce an expected outcome. Landscape literature reviews conducted by CORE-UCLA suggest
that interventions targeting self-efficacy offer the greatest chance of improving adherence
to Enbrel. Self-efficacy plays an important mediating role in self-management activities,
allowing for the adoption and maintenance of health behaviors. Many studies have identified
measures of self-efficacy as significant predictors of adherence in RA patients.
Additionally - though with the caveat that they are methodologically heterogeneous and of
limited generalizability - a number of studies have found that interventions targeting
self-efficacy can significantly improve adherence related outcomes. Seminal works in the
field - including Bandura's Social Cognition Theory and Rosenstock's Health Beliefs Model -
have converged on the following recommendations for behavioral interventions targeting
self-efficacy:
1. Identify and reinforce the patient's past and present successes or accomplishments.
2. Direct patients to observe successful behaviors and coping mechanisms of similar
others, even if this involves having them alter or expand their social network.
3. Provide positive feedback for the patient's efforts or encourage people in the
patient's social network, such as family members or friends, to do this.
4. Facilitate the patient in adopting new health behaviors by ensuring that patients do
not interpret incorrectly how they are feeling.
Enabled by recent advances in microelectronics, signal processing algorithms, and networking
capabilities, wireless health technologies hold the potential to support numerous aspects of
these recommendations. Namely, motion sensors might contribute to the formation of a
complete feedback loop involving self- monitoring, data presentation, and tailored
messaging. Consumer Health Informatics (CHI) applications that offer complete feedback loops
hold the most promise for improving self-efficacy.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01682512 -
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT00539760 -
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT03312465 -
Anatomical Shoulder Domelock System Study
|
||
| Completed |
NCT01208181 -
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
|
Phase 3 | |
| Completed |
NCT03254810 -
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT01711814 -
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
|
Phase 2 | |
| Completed |
NCT03315494 -
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
|
Phase 1 | |
| Withdrawn |
NCT03241446 -
Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)
|
Phase 1 | |
| Completed |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
| Completed |
NCT02553018 -
Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe
|
Phase 3 | |
| Active, not recruiting |
NCT02260778 -
Treat-to-target in RA: Collaboration To Improve adOption and adhereNce
|
N/A | |
| Completed |
NCT02569736 -
Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
|
||
| Completed |
NCT01750931 -
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
|
Phase 2 | |
| Withdrawn |
NCT01204138 -
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
|
Phase 2 | |
| Not yet recruiting |
NCT01154647 -
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
|
N/A | |
| Completed |
NCT00973479 -
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
|
Phase 3 | |
| Completed |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
| Completed |
NCT00975130 -
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
|
Phase 3 | |
| Completed |
NCT00660647 -
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
|
Phase 3 | |
| Completed |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 |