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Pain coping skills training for African Americans with osteoarthritis
Investigator (PI): Allen, Kelli
Performing Organization (PO): (Current): University of North Carolina at Chapel Hill, School of Medicine, Department of Medicine, Division of Rheumatology, Allergy and Immunology, Thurston Arthritis Research Center / (866) 827-2862
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2019
Record Source/Award ID: PCORI/AD-1408-19519
Funding: Total Award Amount: $1,938,442
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background and significance: Osteoarthritis (OA) is a leading cause of pain and disability. African Americans have a greater burden of OA. In this demographic group, compared with Caucasians, OA is more common and associated with more severe pain and activity limitations. Existing research suggests that a program called pain coping skills training (CST) has strong potential for helping African Americans with OA reduce their symptoms. However, important limitations remain about what is known in this research, which limits putting CST into practice. First, there is a need to incorporate the perspectives of African Americans with OA, as well as other key stakeholders, into this program; this is necessary to ensure that the program is culturally relevant and that it can be successfully used in a variety of clinical and community settings. Second, there is still a need for a study that will test the effectiveness of pain CST, specifically among African Americans with OA, in real-world settings. Therefore, the objective of this project is to examine the effectiveness of a culturally enhanced pain CST program among African Americans with OA. Study aims: This project has three specific aims: (1) to engage African American patients with OA, their support partners, health care providers, clinic administrators, and public health representatives in a process of evaluating and enhancing a pain CST program for culturally appropriate content and dissemination potential; (2) to examine the effectiveness of a 12-session, culturally enhanced, telephone-based pain CST program among African Americans with hip or knee OA; and (3) to examine whether individual patient characteristics are associated with different levels of improvement in the CST program. The long-term objective of this research is to develop and disseminate an evidence-based pain CST intervention among African Americans with OA to reduce disparities in outcomes. Study description: After the incorporation of stakeholder perspectives into the pain CST program, we will conduct a randomized controlled trial. We will enroll 248 African Americans with hip or knee OA. They will be randomized into two groups. One group will take part in a two-week pain CST intervention. The other group will be a wait list that receives the pain CST program after completing all follow-up study measures. All study participants will be able to continue any other usual medical care for their OA during the study period. The pain CST intervention includes 12 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain CST is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management. Outcomes: The main study outcome will be the pain subscale of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Other outcomes will include the WOMAC function subscale, coping strategies questionnaire, arthritis self-efficacy scale, depressive symptoms, health-related quality of life, and patient global impression of change. These measures were selected based on stakeholder input and prior research that showed these outcomes as important to patients with OA. Statistical models will be used to compare outcomes between the two study groups at each time point: baseline, 12 weeks (after completion of the initial CST intervention), and 36 weeks (about 6 months after intervention completion). We will also assess whether there are different levels of improvement in outcomes of the CST intervention, based on participant characteristics.
MeSH Terms:
  • Adaptation, Psychological
  • African Americans
  • Canada
  • Communication
  • Cultural Characteristics
  • Disabled Persons
  • Evidence-Based Medicine
  • Humans
  • Models, Statistical
  • Osteoarthritis /*ethnology
  • /*therapy
  • Outcome Assessment, Health Care
  • Pain Management /*methods
  • Public Health
  • Randomized Controlled Trials as Topic
  • Universities
Country: United States
State: North Carolina
Zip Code: 27599
UI: 20153358
CTgovId: NCT02312713
Project Status: Completed
Record History: ('2018: Project extended to 2019.',)