Arthritis Clinical Trial
Official title:
Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities
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.
Background: Arthritis is a prevalent and disabling source of chronic pain for which African
Americans (AAs) bear a disproportionate burden. The purpose of this study is to test a
patient-centered, non-invasive intervention to improve pain outcomes and reduce disparities
in AA and White Veterans with knee arthritis. The intervention is designed to help Veterans
develop a positive mindset, the health benefits of which are well-documented.
Objectives: The primary aim of this study is to evaluate the impact of a positive
intervention on pain and physical functioning in AA and White Veterans with knee arthritis
through a randomized, controlled, clinical trial. It is hypothesized that patients randomized
to a positive activities (PA) intervention will experience improved pain and functioning
compared to patients randomized to an attention control (AC) program, and that these
improvements will be larger for AA than for WH Veterans. The secondary aim of this study is
to identify variables that mediate the effects of the PA intervention on pain and
functioning. It is hypothesized that the effects of the PA intervention will be mediated by
psychosocial variables known to be associated with arthritis outcomes or racial differences
in arthritis outcomes (e.g., depression, self-efficacy, pain coping, perceived
discrimination).
Methods: A randomized, controlled, 2-arm design will be used to compare the effects of a
6-week PA intervention with that of an AC program on pain and functioning at 1, 3, and
6-months post-intervention among AA and WH Veterans with knee arthritis. Approximately 180 AA
and 180 WH primary care patients with knee pain symptoms consistent with arthritis will be
recruited from participating VA medical centers following the original protocol. [Due to
accelerated recruitment of the original target sample, up to 240 additional primary care
patients with knee pain symptoms consistent with OA will be recruited from participating VA
medical centers using inclusion criteria that take into account original ICD-9 codes and
their corresponding ICD-10 codes. The additional patients (including some men and some women,
as resources allow) will be recruited to increase power to detect sex differences in
secondary analyses after the primary aims of the study have been achieved using the original
cohort.] Eligible participants will complete an in-person baseline assessment of study
outcomes, mediators, and control variables and be randomized to a 6-week PA or AC program.
The PA program consists of completing 6 at-home activities (1 per week) that have been shown
to increase positivity. The AC program consists of 6 affectively neutral activities. Both
groups will receive weekly telephone calls from trained interventionists to clarify
instructions for the next week's activity and assess completion of the previous week's
activity. Outcomes and proposed mediating variables will be assessed via telephone surveys at
1 month, 3 months, and 6 months post-intervention. Study outcomes include self-reported pain
and physical functioning as measured by the Western Ontario MacMaster Index. Hypothesized
mediators include depressive symptoms, positive/negative affect, satisfaction with life,
arthritis self-efficacy, pain coping, pain catastrophizing, perceived discrimination, global
stress, and social support. The intervention impact over time and by race (primary aim) will
be tested using linear mixed models that allow repeated measures on the continuous outcomes
for each participant and assess change in outcomes over time. A multiple mediator bootstrap
approach to assess whether the effect of the intervention is mediated by the hypothesized
mediators.
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