Pain Coping Skills Training for African Americans With Osteoarthritis

NCT02560922 | Completed Results

• 2 other identifiers: 15-1189AD-1408-19519
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score

  Baseline, 3 months and 9 months

• Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale

  Baseline, 3 months and 9 months

• Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a)

  Baseline, 3 months and 9 months

• Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score

  Baseline, 3 months and 9 months

• Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score

  Baseline, 3 months and 9 months

Study Arms (2)

Pain Coping Skills Training

EXPERIMENTAL

This group will take part in an 11-week pain coping skills training (CST) intervention.

Behavioral: Pain Coping Skills Training (CST)

Wait list Control

NO INTERVENTION

The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.

Interventions

Pain Coping Skills Training (CST) BEHAVIORAL

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.

Pain Coping Skills Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• 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.

  PMID: 32795282 DERIVED

• 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.

  PMID: 30227841 DERIVED

• 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.

  PMID: 27553385 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Kelli D. Allen, PhD
• Organization: University of North Carolina at Chapel Hill

kdallen@email.unc.edu

919-966-0558

Study Officials

• Kelli D Allen, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 25, 2015
• Study Start: April 1, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: April 1, 2019
• Results First Posted: April 1, 2019

Record last verified: 2018-05

Locations

US (1)