Staying Positive With Arthritis Study

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.

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