Arthritis Clinical Trial
— SPAOfficial title:
Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities
Verified date | March 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Arthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield only small to moderate improvements in pain and are not effective at reducing racial disparities in arthritis pain. According to the biopsychosocial model of pain, there is a need for novel interventions that target psychosocial factors associated with arthritis outcomes and disparities in outcomes. Evidence from the field of psychology suggests that an intervention designed to develop a positive mindset has the potential to improve pain and functioning and reduce racial disparities in patients with arthritis. Interventions to foster a positive mindset have been developed for clinical patient populations but have not yet been fully tested in patients with arthritis or in Veterans, nor have their effects on racial differences in clinical outcomes been examined. This study will address these gaps by testing the impact of an evidence-based positive activities intervention on pain and functioning in African American and White Veterans with knee arthritis.
Status | Completed |
Enrollment | 360 |
Est. completion date | November 9, 2017 |
Est. primary completion date | November 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: The target population will be African American (AA) and White (WH) Veterans with symptomatic knee arthritis. Specific inclusion criteria include: - Age 50 years or older - Receive primary care at a participating study site - Self-report as non-Hispanic black/AA or non-Hispanic WH - Frequent, symptomatic knee pain identified using questions from the OA Initiative - Pain level of 4 or higher on a 0-10 numeric rating scale - Can speak, read, and write in English Exclusion Criteria: Patients will be excluded if they: - Report serious problems with hearing, eyesight, or memory - Report having been diagnosed any type of arthritis other than osteoarthritis or degenerative arthritis - Report that they have been treated for cancer in the last 3 years - Report having had a steroid injection into one or both knees in the past 3 months - Report having had a knee replacement into one or both knees in the past 3 months - Report having plans to have a knee replacement in one or both knees in the next 6 months - Report that there is a reason they cannot complete the study procedures, which include telephone calls and program activities that involve reading and writing - Do not have a telephone number where they can receive telephone calls from research staff - Screen positive for cognitive impairment |
Country | Name | City | State |
---|---|---|---|
United States | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Hausmann LRM, Ibrahim SA, Kwoh CK, Youk A, Obrosky DS, Weiner DK, Vina E, Gallagher RM, Mauro GT, Parks A. Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain. Contemp Clin Trials. 2018 Jan;64:243-253. doi: 10.1016/j.cct.2017.09.001. Epub 2017 Sep 8. — View Citation
Hausmann LRM, Youk A, Kwoh CK, Ibrahim SA, Hannon MJ, Weiner DK, Gallagher RM, Parks A. Testing a Positive Psychological Intervention for Osteoarthritis. Pain Med. 2017 Oct 1;18(10):1908-1920. doi: 10.1093/pm/pnx141. Erratum in: Pain Med. 2017 Sep 1;18(9):1830. — View Citation
Vina ER, Hausmann LRM, Obrosky DS, Youk A, Ibrahim SA, Weiner DK, Gallagher RM, Kwoh CK. Social & psychological factors associated with oral analgesic use in knee osteoarthritis management. Osteoarthritis Cartilage. 2019 Feb 1. pii: S1063-4584(19)30036-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention | Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain. | Baseline to 6 months post-intervention | |
Primary | Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention | Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain. | Baseline to 6 months post-intervention | |
Primary | Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention | Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning. | Baseline to 6 months post-intervention |
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