Wireless Motion Sensors for Rheumatoid Arthritis Patients - Pilot Study

Arthritis, Rheumatoid Clinical Trial

Official title:

Wireless Motion Sensors for Rheumatoid Arthritis Patients - Pilot Study and Preliminary Validation Effort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296632
• Other study ID #: Pro00036773
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: August 18, 2015
• Start date: November 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Enbrel users between week -2 and week 5 of therapy, inclusive.

• Current active prescription for Enbrel with intent to use.

• 21 years or older.

• English speaking

• Have an understanding, ability, and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria:

• Allergic to latex or dry natural rubber

• Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants or other electronic medical equipment.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Medication Adherence

Intervention

Behavioral:
• Motion sensors and daily online assessments
Patients will be asked to wear motion sensors during their waking hours and complete daily Patient Reported Outcomes online assessments.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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 ®). Qual Life Res. 2014 May;23(4):1245-53. doi: 10.1007/s11136-013-0553-z. Epub 2013 Oct 17. — View Citation

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/

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. — View Citation

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. Review. — View Citation

Rosenstock IM, Strecher VJ, Becker MH. Social learning theory and the Health Belief Model. Health Educ Q. 1988 Summer;15(2):175-83. — View Citation

Rosenstock, I. M. (1974). The health belief model and preventive health behavior. Health Education & Behavior, 2, 354-386.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No