Arthritis, RheumatoidNCT02296632
Wireless Motion Sensors for Rheumatoid Arthritis Patients - Pilot Study
An observational study of Arthritis, Rheumatoid and Medication Adherence, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Medication Adherence
- What is being tested?
- Motion sensors and daily online assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis who are candidates to undergo treatment with the drug etanercept.
Who may be able to join
- 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.
Who cannot join
- Allergic to latex or dry natural rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants or other electronic medical equipment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the detailed 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:
- Identify and reinforce the patient's past and present successes or accomplishments.
- Direct patients to observe successful behaviors and coping mechanisms of similar others, even if this involves having them alter or expand their social network.
- 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.
- 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.
- Conditions
- Arthritis, Rheumatoid, Medication Adherence
- Being tested
- Motion sensors and daily online assessments
- Keywords
- Telemedicine, Patient Reported Outcomes
- Medical subject headings
- Arthritis, Rheumatoid, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion sensors and daily online assessmentsBehavioural
Patients will be asked to wear motion sensors during their waking hours and complete daily Patient Reported Outcomes online assessments.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brennan Spiegel, Cedars-Sinai Medical Center
- Investigators
- Brennan Spiegel, MD, MSHS, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296632
- Sponsor's protocol ID
- Pro00036773
- Status last verified
- Aug 2015
- First submitted
- 18 Nov 2014
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10036560Taal 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.
PubMed 8337196Marks 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.
PubMed 15574526Rosenstock 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.
PubMed 3378902Gibbons, 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.
PubMed 24132347Lorig 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.
PubMed 2912463
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Motion Sensors for Rheumatoid Arthritis Patients - Pilot Study and Preliminary Validation Effort
- ClinicalTrials.gov ID
- NCT02296632
- Acronym / sponsor ID
- Pro00036773
- Conditions
- Arthritis, Rheumatoid, Medication Adherence
- Keywords
- Telemedicine, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Identify and reinforce the patient's past and present successes or accomplishments.
- Direct patients to observe successful behaviors and coping mechanisms of similar others, even if this involves having them alter or expand their social network.
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis who are candidates to undergo treatment with the drug etanercept.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Allergic to latex or dry natural rubber
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, hearing aids, cochlear implants or other electronic medical equipment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motion sensors and daily online assessmentsPatients will be asked to wear motion sensors during their waking hours and complete daily Patient Reported Outcomes online assessments. | Behavioural | – |
Primary outcome
Qualitative measures of intervention experience
Time frame: 28 days
We will conduct in-person interviews with participants to learn about their experiences wearing motion sensors and completing daily online assessments.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- BackgroundRosenstock, I. M. (1974). The health belief model and preventive health behavior. Health Education & Behavior, 2, 354-386.
- BackgroundBandura, A. (1996). Social foundations of thought and action: A social cognitive theory. Englewood Cliffs, NJ: Prentice Hall.
- Background: PubMed 10036560Brus 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.
- Background: PubMed 8337196Taal 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.
- Background: PubMed 15574526Marks 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.
- Background: PubMed 3378902Rosenstock 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.
- BackgroundGibbons, 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/
- BackgroundCampbell, D. & Stanley, J. (1963). Experimental and quasi-experimental designs for research. Chicago, IL: Rand-McNally.
- Background: PubMed 24132347Christodoulou 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.
- Background: PubMed 2912463Lorig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brennan Spiegel, MD, MSHS principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Medication Adherence, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative measures of intervention experience (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02296632, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.