Web-based Support to Manage Arthritis Pain

Phase 2

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Other Arthritic Conditions (e.g., Psoriatic Arthritis)

• Registration Number: NCT01463189
• Lead Sponsor: Inflexxion, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-11-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-07
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

1. Be at least 18 years of age;
2. Be able to provide informed consent
3. Be able to read and speak English
4. Have reliable Internet access and e-mail
5. Have a self-reported doctor diagnosis of arthritis, limited to the following conditions - osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), or other arthritis conditions (e.g., psoriatic arthritis)
6. Have a self-reported pain level of 4 or more in the past week on the 0 to 10 Numeric Rating Scale (McCaffery & Beebe, 1993) because 4 indicates moderate or higher level of pain.

Exclusion Criteria

1. Participation in another Inflexxion pain management study.
2. Participation in an online research study related to arthritis in the past year
3. Currently in pain from a recent injury
4. Has been hospitalized for non-medical reasons related to emotional or mental health in the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention	baseline, post intervention, 3 months post intervention, and 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.
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	baseline, post-intervention, 3 months post-intervention, and 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.
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	baseline, post-intervention, 3 months post-intervention, and 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).

Secondary Outcome Measures

Name	Time	Method
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	baseline, post intervention, 3 months post intervention, and 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.
Change in affect from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention	baseline, post-intervention, 3 months post-intervention, and 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.

Trial Locations

Locations (1)

Inflexxion, Inc.; 🇺🇸 Newton, Massachusetts, United States