Pain coping skills training for African Americans with osteoarthritis (STAART): study protocol of a randomized controlled trial

Abstract

BackgroundAfrican Americans bear a disproportionate burden of osteoarthritis (OA), with higher prevalence rates, more severe pain, and more functional limitations. One key barrier to addressing these disparities has been limited engagement of African Americans in the development and evaluation of behavioral interventions for management of OA. Pain Coping Skills Training (CST) is a cognitive-behavioral intervention with shown efficacy to improve OA-related pain and other outcomes. Emerging data indicate pain CST may be a promising intervention for reducing racial disparities in OA symptom severity. However, there are important gaps in this research, including incorporation of stakeholder perspectives (e.g. cultural appropriateness, strategies for implementation into clinical practice) and testing pain CST specifically among African Americans with OA. This study will evaluate the effectiveness of a culturally enhanced pain CST program among African Americans with OA.Methods/DesignThis is a randomized controlled trial among 248 participants with symptomatic hip or knee OA, with equal allocation to a pain CST group and a wait list (WL) control group. The pain CST program incorporated feedback from patients and other stakeholders and involves 11 weekly telephone-based sessions. Outcomes are assessed at baseline, 12 weeks (primary time point), and 36 weeks (to assess maintenance of treatment effects). The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index, and secondary outcomes include self-efficacy, pain coping, pain interference, quality of life, depressive symptoms, and global assessment of change. Linear mixed models will be used to compare the pain CST group to the WL control group and explore whether participant characteristics are associated with differential improvement in the pain CST program. This research is in compliance with the Helsinki Declaration and was approved by the Institutional Review Boards of the University of North Carolina at Chapel Hill, Durham Veterans Affairs Medical Center, East Carolina University, and Duke University Health System.DiscussionThis culturally enhanced pain CST program could have a substantial impact on outcomes for African Americans with OA and may be a key strategy in the reduction of racial health disparities.Trial registrationClinicalTrials.gov, NCT02560922, registered 9/22/2015.

Pain coping skills training for African Americans with osteoarthritis study: baseline participant characteristics and comparison to prior studies

“…Based on descriptions of comparator studies, none had a particular focus on identifying patient populations with greatest risks or needs. We utilized proactive and culturally tailored recruitment methods [ 8 ] and were able to meet the study sample size goal within the specified timeline, potentially reflecting a high degree of receptivity to this type of intervention in this patient group. Consented patients were slightly younger than those who declined or were ineligible, but there was a more pronounced gender difference, with the consented group including more females than those who declined or were ineligible.…”

“…Unfortunately, we did not identify any comparator studies that measured this important construct. We expected that religious values would be important to a substantial proportion of STAART participants, and therefore one aspect of cultural tailoring involved encouraging participants to integrate elements of their spirituality or religious faith into their practice of pain coping when they felt it was important do so [ 8 ]. For example, during cognitive restructuring sessions, if participants identified that their faith played an integral role in reframing their pain-related challenges, this was further explored and built upon during the intervention.…”

“…The STAART study, described in detail previously [ 8 ], is a randomized controlled trial of 248 African Americans with symptomatic hip or knee OA. The STAART study enrolled only African Americans (vs inclusion of other racial groups) so that in-depth efforts could be focused on this demographic group with a high risk for poorer OA and pain-related outcomes.…”

“…Study inclusion were 1) Diagnosis of knee or hip OA, verified by self-reported diagnosis from a medical professional, including items based on the American College of Rheumatology clinical criteria for knee or hip OA, 2) Self-report of pain, aching, or stiffness in one or both knees or hips on most days of the week, 3) Patient of the UNC Health Care System or Durham VAMC. Exclusion criteria have been described previously [ 8 ] and generally include other pain-related conditions that confound study outcomes or health conditions that would prevent participation in the intervention (e.g., severe hearing loss since this was a phone-based intervention).…”

“…Because of these well-documented racial differences, the Institute of Medicine has identified interventions to reduce disparities in OA and other musculoskeletal diseases among its top 25 (highest tier) priority topics for comparative effectiveness research [ 7 ]. In alignment with this priority, the Pain Coping S kills T raining for A frican A mericans with Osteoa RT thritis (STAART) study is evaluating the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with OA [ 8 ]. There were several factors underlying the choice of a pain CST intervention to address racial disparities in OA-related pain and other outcomes.…”