Clinical trial NCT02560922: Pain Coping Skills Training for African Americans With Osteoarthritis
Official title: Pain Coping Skills Training for African Americans With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Knee Osteoarthritis
Hip Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-09-25
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of an 11-session, culturally enhanced, telephone-based pain coping skills training program among African Americans with hip or knee osteoarthritis (OA). The study team will enroll n=248 African Americans with hip or knee OA. The participants will be randomized into two groups. One group will take part in an 11-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 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training 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. 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.

Detailed description: Background and Significance: OA is a leading cause of pain and disability. African Americans have a greater burden of OA. In this demographic group OA is more common and associated with more severe pain and activity limitations, compared with Caucasians. Prior research suggests that a program called pain Coping Skills Training (CST) has strong potential for helping African Americans with OA to reduce their symptoms. However, there are still some important limitations to what is known in this research, which limits putting this program 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 important for ensuring the program is culturally relevant and 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.) 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.) Examine the effectiveness of a 12-session, culturally enhanced, telephone-based pain CST program among African Americans with hip or knee OA. 3.) 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: Following the incorporation of Stakeholder perspectives into the pain CST program, the investigators will conduct a randomized controlled trial. The investigators will enroll n=248 African Americans with hip or knee OA. They will be randomized into two groups. One group will take part in a 2-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 coping skills training 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. 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 are 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). The investigators will also assess whether there are different levels of improvement in outcomes of the CST intervention, based on participant characteristics.

Eligibility criteria: Inclusion Criteria:

* African American (based on self-reported race)
* Diagnosis of hip or knee osteoarthritis; current joint symptoms

Exclusion Criteria:

* Diagnosis of gout (in knee or hip), rheumatoid arthritis, fibromyalgia, other systemic rheumatic disease
* Dementia or other memory loss condition
* Active diagnosis of psychosis, serious personality disorder, or current uncontrolled substance abuse
* Total hip / knee replacement surgery, other knee / hip surgery, anterior cruciate ligament tear, or other significant hip / knee injury in the past 6 months
* Severely impaired hearing or speech (patients must be able to participate in video-conference sessions)
* Unable to speak English
* Participating in another OA intervention or CST study
* Unwilling to be randomized either study arm
* Lower extremity paralysis

Primary outcomes:
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale
timeFrame: Baseline, 3 months and 9 months
Secondary outcomes:
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score
timeFrame: Baseline, 3 months and 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale
timeFrame: Baseline, 3 months and 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a)
timeFrame: Baseline, 3 months and 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score
timeFrame: Baseline, 3 months and 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score
timeFrame: Baseline, 3 months and 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ)
timeFrame: Baseline, 3 months, 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8)
timeFrame: Baseline, 3 months and 9 months
measure: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale
timeFrame: Baseline, 3 months and 9 months
measure: Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months
timeFrame: Baseline, 3 months and 9 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Kelli D Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dharmasri CJ, Griesemer I, Arbeeva L, Campbell LC, Cene CW, Keefe FJ, Oddone EZ, Somers TJ, Allen KD. Acceptability of telephone-based pain coping skills training among African Americans with osteoarthritis enrolled in a randomized controlled trial: a mixed methods analysis. BMC Musculoskelet Disord. 2020 Aug 14;21(1):545. doi: 10.1186/s12891-020-03578-7.
citation: Allen KD, Arbeeva L, Cene CW, Coffman CJ, Grimm KF, Haley E, Keefe FJ, Nagle CT, Oddone EZ, Somers TJ, Watkins Y, Campbell LC. Pain coping skills training for African Americans with osteoarthritis study: baseline participant characteristics and comparison to prior studies. BMC Musculoskelet Disord. 2018 Sep 19;19(1):337. doi: 10.1186/s12891-018-2249-6.
citation: Schrubbe LA, Ravyts SG, Benas BC, Campbell LC, Cene CW, Coffman CJ, Gunn AH, Keefe FJ, Nagle CT, Oddone EZ, Somers TJ, Stanwyck CL, Taylor SS, Allen KD. Pain coping skills training for African Americans with osteoarthritis (STAART): study protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 23;17(1):359. doi: 10.1186/s12891-016-1217-2.