A Phase 2 interventional study of painACTION: Arthritis in Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis, sponsored by Inflexxion, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-10.
Sponsored by Inflexxion, Inc. · Phase 2, Interventional, and Supportive care
Development of an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self-management strategies.
One of every five adults in the United States (46.4 million people) is affected by arthritis. Increasing the number of days individuals are free of arthritis pain is one of the Healthy People 2010 objectives. Although there are a variety of medical treatments and medications available, self-management is a critical component in helping arthritis sufferers learn how to identify, avoid, and help manage their pain. Unfortunately, clinicians face significant time pressure, leaving little time for desired patient-provider education and collaboration. This is an important omission as tailored advice (e.g., specific exercises to reduce pain) from health providers could enable behavior change and improve outcomes. Therefore, widely accessible and tailored interventions that address motivational issues are needed to facilitate self-management education among arthritis patients. Because of its reach across demographic groups, the Internet is an excellent vehicle for offering a self-management program to arthritis sufferers. The investigators propose to develop an interactive, online pain self-management program for adults who suffer from pain associated with osteoarthritis, rheumatoid arthritis, Ankylosing spondylitis, and other arthritic conditions (e.g., psoriatic arthritis) using principles from Social Cognitive Theory (Bandura, 1977). This online health intervention, painACTION: Arthritis, will provide clinically reliable information about diagnosis, treatment, and management of arthritis, written for health consumers in a clear and engaging manner to help increase their skills and confidence to use self-management strategies. Moreover, it will be designed to complement and connect to our other SBIR-supported pain online health interventions (chronic back pain, migraine pain, neuropathic pain) to be a more comprehensive resource for those seeking pain management assistance. The most unique aspect of painACTION: Arthritis is that it includes three technological innovations -- a Web 2.0-enabled platform, a Custom Recommendation Engine, and Dynamic Lessons - to help people self manage their arthritis pain. In Phase I the investigators accomplished two important objectives: 1) established the feasibility of painACTION: Arthritis as an intervention and a technical project and 2) generated preliminary plans for the content, design, and technical development of painACTION: Arthritis. In Phase II the investigators will produce the program and test its efficacy.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 228 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Inflexxion, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Behavioral: painACTION: Arthritis
Participants will be asked to complete eight 20-minute sessions on the site over a four-week intervention period (two site visits per week), and complete five 20-minute "booster" sessions (one site visit per month) during the follow up period. Each session will have a minimum set of requirements. Specific details about the requirements for each session will be provided in the session logs.
Change in cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Arthritis Self-efficacy Scale (Lorig et al., 1989) is an 8-item questionnaire that assesses a patient's ability to determine self-efficacy. Pain Catastrophizing Scale (PCS) (Sullivan et al., 1995) was developed to assess three components of catastrophizing: rumination, magnification, and helplessness. The scale consists of 13 items rated from 0-4 (0 = not at all, 4 = all the time). Pain Awareness Questionnaire (Berman et al., 2009) is a 7-item questionnaire that assesses a patient's awareness of their current pain.
Time frame: baseline, post intervention, 3 months post intervention, and 6 months post intervention
Change in self management behaviors from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Exercise Behaviors (Lorig et al., 1996) is a 6-item questionnaire assessing the total time a patient had participated in various forms of exercise (e.g., stretching). Cognitive Symptom Management (Lorig et al., 1996) is a 6-item questionnaire assessing a patient's ability to manage their symptoms. This scale is rated on a 0 to 5 scale: 0 = never to 5 = always. Communication with Physicians (Lorig et al., 1996) is a 3-item scale assessing a patient's communication with their physicians. This scale is rated on a 0 to 5 scale: 0 = never to 5 = always.
Time frame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Change in pain and functioning from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Brief Pain Inventory - Short Form (BPI-SF) (Cleeland, 1991) uses a 0 to 10 numeric rating scale to obtain information on the intensity of pain, the degree to which pain interferes with function, pain relief, pain quality, and the patient's perception of the cause of pain (6 items).
Time frame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Change in quality of life from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
The Arthritis Impact Measurement Scale-2-SF (Guillemin et al., 1997) is a 26-item scale that measures 5-domains of health status (e.g., physical, role, work, and social functioning.) Six additional items from the Ankylosing Spondylitis-AIMS will be added for additional validity of spine and mobility functioning for the participants with AS (Guillemin et al., 1999). Patient Global Impression of Change Scale (Guy, 1976) is an outcome measure of global improvement with treatment and consists of a single-item self-rating.
Time frame: baseline, post intervention, 3 months post intervention, and 6 months post intervention
Change in affect from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
Depression Anxiety Stress Scales (DASS-21, Lovibond \& Lovibond, 1995). The DASS is a 21-item questionnaire that distinguishes symptoms of depression, anxiety, and stress.
Time frame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Inflexxion, Inc.