Web-based Support to Manage Arthritis Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kimberlee Trudeau, Inflexxion, Inc.
ClinicalTrials.gov Identifier:
NCT01463189
First received: October 20, 2011
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Other Arthritic Conditions (e.g., Psoriatic Arthritis)
Behavioral: painACTION: Arthritis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Web-based Support to Manage Arthritis Pain

Resource links provided by NLM:


Further study details as provided by Inflexxion, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Depression Anxiety Stress Scales (DASS-21, Lovibond & Lovibond, 1995). The DASS is a 21-item questionnaire that distinguishes symptoms of depression, anxiety, and stress.


Enrollment: 228
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: painACTION: Arthritis 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.
No Intervention: treatment as usual

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463189

Locations
United States, Massachusetts
Inflexxion, Inc.
Newton, Massachusetts, United States, 02459
Sponsors and Collaborators
Inflexxion, Inc.
Investigators
Principal Investigator: Kimberlee J Trudeau, Ph.D. Inflexxion, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Kimberlee Trudeau, Research Scientist, Inflexxion, Inc.
ClinicalTrials.gov Identifier: NCT01463189     History of Changes
Other Study ID Numbers: 5R44AR061191
Study First Received: October 20, 2011
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Inflexxion, Inc.:
arthritis
self management

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Osteoarthritis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014