Pain Coping Skills Training for African Americans With Osteoarthritis



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:April 2016
End Date:May 2, 2018

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Phone: 919-966-0558
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials