N/A
N=360
Staying Positive With Arthritis Study
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02223858 ↗Enrolled (actual)
360
Serious AEs
5.6%
Results posted
Feb 2019
Primary outcome: Primary: Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention — 50.24; 47.42; 45.42; 43.57 units on a scale — p=0.791
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Activities (PA) Program (Behavioral); Attention Control (AC) Program (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention |
50.24; 47.42; 45.42; 43.57; 43.87; 43.32 | 0.791 |
| PRIMARY Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention |
47.94; 45.70; 44.61; 43.08; 43.39; 43.32 | 0.880 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02223858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.