AzTrials
AzTrials

OsteoarthritisSTAARTNCT02560922

Pain Coping Skills Training for African Americans With Osteoarthritis

A study testing Pain Coping Skills Training (CST) in people with Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Pain Coping Skills Training (CST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
1 siteUnited States
Study dates
Apr 2016to 2 May 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • Participating in another OA intervention or CST study
  • Unwilling to be randomized either study arm
  • Lower extremity paralysis

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UNC Thurston Arthritis Research Center

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

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.

Read the 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.

Conditions
Osteoarthritis
Being tested
Pain Coping Skills Training (CST)
Keywords
Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Coping Skills Training (CST)Behavioural

    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.

Study groups in NCT02560922
Study groupRoleWhat they receive
Pain Coping Skills TrainingExperimentalThis group will take part in an 11-week pain coping skills training (CST) intervention.
Receives: Behavioral: Pain Coping Skills Training (CST)
Wait list ControlNo interventionThe other group will be the wait list group and will receive the pain CST program after completing all follow-up study measures.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 3 months and 9 months

Secondary outcomes (9)
  1. 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.

    Measured: Baseline, 3 months and 9 months

  2. 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.

    Measured: Baseline, 3 months and 9 months

  3. 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.

    Measured: Baseline, 3 months and 9 months

  4. 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.

    Measured: Baseline, 3 months and 9 months

  5. 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.

    Measured: Baseline, 3 months and 9 months

  6. 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.

    Measured: Baseline, 3 months, 9 months

  7. 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.

    Measured: Baseline, 3 months and 9 months

  8. 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.

    Measured: Baseline, 3 months and 9 months

  9. 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.

    Measured: Baseline, 3 months and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion2 May 2018
  4. Study completion2 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02560922
Sponsor's protocol ID
15-1189
Other IDs
AD-1408-19519
Acronym
STAART
Status last verified
May 2018
First submitted
22 Sep 2015
Last updated
1 Apr 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 32795282
  • 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.

    PubMed 30227841
  • 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.

    PubMed 27553385

Questions about this trial

What is this clinical trial studying?

A study testing Pain Coping Skills Training (CST) in people with Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560922, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in