Wireless Motion Sensors for Rheumatoid Arthritis Patients - Pilot Study

August 18, 2015 updated by: Brennan Spiegel, Cedars-Sinai Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with rheumatoid arthritis who are candidates to undergo treatment with the drug etanercept.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00036773

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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