Web-based Support to Manage Arthritis Pain

NCT01463189 | Completed Phase 2 DMC

• 1 other identifier: 5R44AR061191
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

arthritis; self management

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  baseline, post-intervention, 3 months post-intervention, and 6 months post-intervention

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

painACTION: Arthritis

EXPERIMENTAL

Behavioral: painACTION: Arthritis

treatment as usual

NO INTERVENTION

Interventions

painACTION: Arthritis BEHAVIORAL

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.

painACTION: Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age;
• Be able to provide informed consent
• Be able to read and speak English
• Have reliable Internet access and e-mail
• 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)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Inflexxion, Inc.: lead

Study Sites (1)

Inflexxion, Inc.

Newton, Massachusetts, 02459, United States

Location

Related Publications (11)

• Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

  PMID: 847061 BACKGROUND

• Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.

  PMID: 2912463 BACKGROUND

• Lorig K, Stewart A, Ritter P, González V, Laurent D, Lynch J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications, 1996.

  BACKGROUND

• Sullivan MJL. The pain catastrophizing scale: Development and validation. Psychological Assessment 7(4):524-532, 1995.

  BACKGROUND

• Berman RL, Iris MA, Bode R, Drengenberg C. The effectiveness of an online mind-body intervention for older adults with chronic pain. J Pain. 2009 Jan;10(1):68-79. doi: 10.1016/j.jpain.2008.07.006. Epub 2008 Sep 5.

  PMID: 18774342 BACKGROUND

• Cleeland CS. Brief Pain Inventory (Short Form). Pain Research Group. Retrieved March 17, 2009, from http://prc.coh.org/pdf/BPI%20Short%20Version.pdf, 1991.

  BACKGROUND

• Guillemin F, Coste J, Pouchot J, Ghezail M, Bregeon C, Sany J. The AIMS2-SF: a short form of the Arthritis Impact Measurement Scales 2. French Quality of Life in Rheumatology Group. Arthritis Rheum. 1997 Jul;40(7):1267-74. doi: 10.1002/1529-0131(199707)40:73.0.CO;2-L.

  PMID: 9214427 BACKGROUND

• Guillemin F, Challier B, Urlacher F, Vancon G, Pourel J. Quality of life in ankylosing spondylitis: validation of the ankylosing spondylitis Arthritis Impact Measurement Scales 2, a modified Arthritis Impact Measurement Scales Questionnaire. Arthritis Care Res. 1999 Jun;12(3):157-62. doi: 10.1002/1529-0131(199906)12:33.0.co;2-r.

  PMID: 10513505 BACKGROUND

• Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: U.S. Department of Health, Education, and Welfare, 1976.

  BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• McCaffery M, Beebe A. Pain: Clinical Manual for Nursing Practice. Baltimore: V.V. Mosby Company, 1993.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Kimberlee J Trudeau, Ph.D.

  Inflexxion, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: November 1, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

US (1)