Clinical trial NCT01463189: Web-based Support to Manage Arthritis Pain
Official title: Web-based Support to Manage Arthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Other Arthritic Conditions (e.g., Psoriatic Arthritis)
Keywords: arthritis
self management
Lead sponsor: Inflexxion, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-01
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
timeFrame: baseline, post intervention, 3 months post intervention, and 6 months post intervention
measure: 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
timeFrame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
measure: 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
timeFrame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Secondary outcomes:
measure: 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
timeFrame: baseline, post intervention, 3 months post intervention, and 6 months post intervention
measure: Change in affect from baseline to: post intervention post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention
timeFrame: baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention
Other outcomes:
Locations:
city: Newton
country: United States
facility: Inflexxion, Inc.
state: Massachusetts
Study officials:
affiliation: Inflexxion, Inc.
name: Kimberlee J Trudeau, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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