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Web-based Support to Manage Arthritis Pain

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ClinicalTrials.gov Identifier: NCT01463189
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Kimberlee Trudeau, Inflexxion, Inc.

Tracking Information
First Submitted Date  ICMJE October 20, 2011
First Posted Date  ICMJE November 1, 2011
Last Update Posted Date December 10, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • Change in cognitions from baseline to: post intervention (approximately 1 month post baseline), 3 months post intervention, 6 months post intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01463189 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2011)
  • 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based Support to Manage Arthritis Pain
Official Title  ICMJE Web-based Support to Manage Arthritis Pain
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Other Arthritic Conditions (e.g., Psoriatic Arthritis)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: painACTION: Arthritis
    Intervention: Behavioral: painACTION: Arthritis
  • No Intervention: treatment as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2011)
228
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01463189
Other Study ID Numbers  ICMJE 5R44AR061191( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimberlee Trudeau, Inflexxion, Inc.
Study Sponsor  ICMJE Inflexxion, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kimberlee J Trudeau, Ph.D. Inflexxion, Inc.
PRS Account Inflexxion, Inc.
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP