Ignite Creation Date:
2024-05-06 @ 7:37 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02560922
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2015-09-22
Brief Title:
Pain Coping Skills Training for African Americans With Osteoarthritis
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Pain Coping Skills Training for African Americans With Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAART
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 n248 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
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 n248 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
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 n248 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AD-1408-19519 | OTHER_GRANT | PCORI | None |