Pain Coping Skills Training for African Americans With Osteoarthritis

Osteoarthritis Clinical Trial

— STAART  

Official title:

Pain Coping Skills Training for African Americans With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560922
• Other study ID #: 15-1189
• Secondary ID: AD-1408-19519
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2, 2018

Study information

• Verified date: May 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• Pain Coping Skills Training (CST)
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.

Locations

Country	Name	City	State
United States	UNC Thurston Arthritis Research Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale	Change over time in the primary outcome measure for this study, the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with a total range of 0-20 with higher scores indicating worse symptoms and function.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score	In addition to the pain subscale, the WOMAC includes stiffness (2 items) and function (17 items) subscales. All items are listed rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with ranges of 0-96 for the total score (pain, stiffness, and function subscales), with higher scores indicating worse symptoms and function.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale	In addition to the pain subscale, the WOMAC includes stiffness (2 items) and function (17 items) subscales. All items are listed rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with ranges of 0-68 for the function subscale, with higher scores indicating worse symptoms and function.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a)	The PROMIS Pain Interference (Short Form 6a) instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher scores indicate greater pain interference.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score	This 12-item measure covers domains of general health, physical health, work and activity limitations, and emotional health. Mental Health and Physical Health Composite Scores were computed, both of which range from 0-100 with lower scores indicating poorer health.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score	This 12-item measure covers domains of general health, physical health, work and activity limitations, and emotional health. Mental Health and Physical Health Composite Scores were computed, both of which range from 0-100 with lower scores indicating poorer health.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ)	This scale includes 48 items that assess 6 cognitive domains (Catastrophizing, Diverting Attention, Ignoring Sensations, Coping Self-Statements, Reinterpreting Pain Sensations, Praying-Hoping) and 1 behavioral domain (Increasing Behavioral Activities). Each domain includes 6 items, and participants rate the frequency of their use of specific coping strategies on a 7-point Likert scale from 0 ("Never do that") to 6 ("Always do that"). A Total Coping Attempts score was created, which includes 5 cognitive domains and 1 behavioral domain but excludes the Catastrophizing domain, similar to prior studies. Total range is 252, with higher scores indicating more coping attempts.	Baseline, 3 months, 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8)	This 8-item survey of depressive symptoms includes items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV) [38]. All items are scored as 0 (not at all) to 3 (nearly every day), with higher scores indicating more depressive symptoms.	Baseline, 3 months and 9 months
Secondary	Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale	This scale includes 8 items asking respondents how certain they are that they can manage arthritis pain and keep it from interfering with specific activities All items are scored on a scale of 1 (very uncertain) to 10 (very certain), with higher scores indicating greater self-efficacy for managing arthritis symptoms.	Baseline, 3 months and 9 months
Secondary	Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months	This measure asks participants to describe their change in pain on a 7-point rating scale with the following options: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," and "very much worse." The total range is 0-7, with lower scores indicating more improvement.	Baseline, 3 months and 9 months