Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03582683
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2018-06-14
Brief Title:
A Community-Based Chronic Pain Self-Management Program in West Virginia
Sponsor:
West Virginia University
Organization:
West Virginia University
Study Overview
Official Title:
A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
Chronic pain CP affects 1 in 3 US adults and costs up to 635 billion annually in medical costs and lost work productivity Use of opioid medications for CP has risen in the US and opioid overdose deaths have quadrupled yet with no overall change in pain Although one-third of US adults have CP there is a lack of affordable non-pharmacological evidence-based community-delivered interventions for people with CP
One program the Chronic Pain Self-Management Program CPSMP provides short-term improvements in pain but its long-term effects have not been evaluated This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia WV The objectives of this community-engaged randomized wait-list controlled study are to 1 determine the short- 26 weeks and long-term 52 weeks effectiveness of the 6-week CPSMP in adults with CP in WV 2 evaluate the Reach number of participants completers Effectiveness outcomes Adoption number of sites leaders trainings Implementation fidelity and Maintenance satisfaction continuation of CPSMP using the RE-AIM Framework and 3 disseminate the results to key stakeholders including evidence-based organizations public health practitionersresearchers and healthcare providers
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV Greenbrier rural and Wood urban Participants will attend free 25-hour weekly sessions for 6 weeks Self-reported performance-based and physiological data will be collected at baseline and 26 and 52 weeks after the start of the intervention The primary outcomes are pain severity quality interference medication use mental health mood anxiety catastrophizing function self-efficacy coping health-related quality of life sleep fatigue communication physical activity healthcare utilization missed work days and gait speed
One program the Chronic Pain Self-Management Program CPSMP provides short-term improvements in pain but its long-term effects have not been evaluated This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia WV The objectives of this community-engaged randomized wait-list controlled study are to 1 determine the short- 26 weeks and long-term 52 weeks effectiveness of the 6-week CPSMP in adults with CP in WV 2 evaluate the Reach number of participants completers Effectiveness outcomes Adoption number of sites leaders trainings Implementation fidelity and Maintenance satisfaction continuation of CPSMP using the RE-AIM Framework and 3 disseminate the results to key stakeholders including evidence-based organizations public health practitionersresearchers and healthcare providers
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV Greenbrier rural and Wood urban Participants will attend free 25-hour weekly sessions for 6 weeks Self-reported performance-based and physiological data will be collected at baseline and 26 and 52 weeks after the start of the intervention The primary outcomes are pain severity quality interference medication use mental health mood anxiety catastrophizing function self-efficacy coping health-related quality of life sleep fatigue communication physical activity healthcare utilization missed work days and gait speed
Detailed Description:
Chronic pain CP affects 1 in 3 US adults and costs up to 635 billion annually in medical costs and lost work productivity The impact of CP is worse in people with both CP and comorbid chronic diseases such as arthritis diabetes and heart disease Use of opioid medications for CP has risen in the US and opioid overdose deaths have quadrupled yet with no overall change in pain Although one-third of US adults have CP there is a lack of affordable non-pharmacological evidence-based community-delivered interventions for people with CP Thus there is a vital need to rigorously test more interventions that can be brought to scale and widely disseminated in the US
One program the Chronic Pain Self-Management Program CPSMP provides short-term improvements in pain but its long-term effects have not been evaluated This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia WV With one of the worst health profiles in the US WV has the highest rates of arthritis diabetes heart disease and drug overdose deaths and therefore has a compelling need for the CPSMP The objectives of this community-engaged randomized wait-list controlled study are to 1 determine the short- 26 weeks and long-term 52 weeks effectiveness of the 6-week CPSMP in adults with CP in WV 2 evaluate the Reach number of participants completers Effectiveness outcomes Adoption number of sites leaders trainings Implementation fidelity and Maintenance satisfaction continuation of CPSMP using the RE-AIM Framework and 3 disseminate the results to key stakeholders including evidence-based organizations public health practitionersresearchers and healthcare providers
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV Greenbrier rural and Wood urban Participants will attend free 25-hour weekly sessions for 6 weeks Two trained leaders will facilitate group discussions on managing pain emotions depression fatigue and sleep proper exercise nutrition and medication use weight management strategies for effective communication with healthcare professionals evaluating treatments and pacingplanning Self-reported performance-based and physiological data will be collected at baseline and 26 and 52 weeks after the start of the intervention The primary outcomes are pain severity quality interference medication use mental health mood anxiety catastrophizing function self-efficacy coping health-related quality of life sleep fatigue communication physical activity healthcare utilization missed work days and gait speed
One program the Chronic Pain Self-Management Program CPSMP provides short-term improvements in pain but its long-term effects have not been evaluated This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia WV With one of the worst health profiles in the US WV has the highest rates of arthritis diabetes heart disease and drug overdose deaths and therefore has a compelling need for the CPSMP The objectives of this community-engaged randomized wait-list controlled study are to 1 determine the short- 26 weeks and long-term 52 weeks effectiveness of the 6-week CPSMP in adults with CP in WV 2 evaluate the Reach number of participants completers Effectiveness outcomes Adoption number of sites leaders trainings Implementation fidelity and Maintenance satisfaction continuation of CPSMP using the RE-AIM Framework and 3 disseminate the results to key stakeholders including evidence-based organizations public health practitionersresearchers and healthcare providers
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV Greenbrier rural and Wood urban Participants will attend free 25-hour weekly sessions for 6 weeks Two trained leaders will facilitate group discussions on managing pain emotions depression fatigue and sleep proper exercise nutrition and medication use weight management strategies for effective communication with healthcare professionals evaluating treatments and pacingplanning Self-reported performance-based and physiological data will be collected at baseline and 26 and 52 weeks after the start of the intervention The primary outcomes are pain severity quality interference medication use mental health mood anxiety catastrophizing function self-efficacy coping health-related quality of life sleep fatigue communication physical activity healthcare utilization missed work days and gait speed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None