NCT02296632|Completed
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Sponsor study identifier
observational
7
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 18, 2014
Actual (reported)November 20, 2014
Actual (reported)August 2015
Actual (reported)August 2015
Actual (reported)Qualitative measures of intervention experience
We will conduct in-person interviews with participants to learn about their experiences wearing motion sensors and completing daily online assessments.
28 days
Patients will be asked to wear motion sensors during their waking hours and complete daily Patient Reported Outcomes online assessments.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with rheumatoid arthritis who are candidates to undergo treatment with the drug etanercept.
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Rosenstock, I. M. (1974). The health belief model and preventive health behavior. Health Education & Behavior, 2, 354-386.
Bandura, A. (1996). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice Hall.
Brus H, van de Laar M, Taal E, Rasker J, Wiegman O. Determinants of compliance with medication in patients with rheumatoid arthritis: the importance of self-efficacy expectations. Patient Educ Couns. 1999 Jan;36(1):57-64. doi: 10.1016/s0738-3991(98)00087-1.
Brennan Spiegel, MD, MSHS
Cedars-Sinai Medical Center
7 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2014
First Posted
November 20, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
ACTH Gel Therapy in Rheumatoid Arthritis
Contact the study team to confirm eligibility.
Taal E, Rasker JJ, Seydel ER, Wiegman O. Health status, adherence with health recommendations, self-efficacy and social support in patients with rheumatoid arthritis. Patient Educ Couns. 1993 May;20(2-3):63-76. doi: 10.1016/0738-3991(93)90122-d.
Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part I). Health Promot Pract. 2005 Jan;6(1):37-43. doi: 10.1177/1524839904266790.
Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the Health Belief Model. Health Educ Q. 1988 Summer;15(2):175-83. doi: 10.1177/109019818801500203.
Gibbons, M. C., Wilson, R. F., Samal, L., Lehmann, C. U., Dickersin, K., Lehmann, H. P., Bass, E. B. (2009). Impact of consumer health informatics applications (Executive Summary). Rockville, MD: Agency for Healthcare Research and Quality. Retrieved from: http://www.ncbi.nlm.nih.gov/books/NBK32641/
Campbell, D. & Stanley, J. (1963). Experimental and quasi-experimental designs for research. Chicago, IL: Rand-McNally.
Christodoulou C, Schneider S, Junghaenel DU, Broderick JE, Stone AA. Measuring daily fatigue using a brief scale adapted from the Patient-Reported Outcomes Measurement Information System (PROMIS (R)). Qual Life Res. 2014 May;23(4):1245-53. doi: 10.1007/s11136-013-0553-z. Epub 2013 Oct 17.
Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
August 19, 2015
Record last verified: 2015-08
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Source: ClinicalTrials.gov.
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