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Pain Coping Skills Training for African Americans With Osteoarthritis (STAART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02560922
Recruitment Status : Completed
First Posted : September 25, 2015
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Behavioral: Pain Coping Skills Training (CST) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pain Coping Skills Training for African Americans With Osteoarthritis
Study Start Date : April 2016
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pain Coping Skills Training
This group will take part in an 11-week pain coping skills training (CST) 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.

No Intervention: Wait list Control
The other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.



Primary Outcome Measures :
  1. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale [ Time Frame: Baseline, 3 months and 9 months ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  2. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  3. Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a) [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  4. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  5. Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  6. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ) [ Time Frame: Baseline, 3 months, 9 months ]
    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.

  7. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8) [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  8. Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale [ Time Frame: Baseline, 3 months and 9 months ]
    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.

  9. Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months [ Time Frame: Baseline, 3 months 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560922


Locations
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United States, North Carolina
UNC Thurston Arthritis Research Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kelli D Allen, PhD UNC Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02560922    
Other Study ID Numbers: 15-1189
AD-1408-19519 ( Other Grant/Funding Number: PCORI )
First Posted: September 25, 2015    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019
Last Verified: May 2018
Keywords provided by University of North Carolina, Chapel Hill:
Osteoarthritis
Knee Osteoarthritis
Hip Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases