A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West Virginia University
- Enrollment
- 196
- Locations
- 2
- Primary Endpoint
- Pain severity
Study Overview
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 practitioners/researchers, 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, 2.5-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 practitioners/researchers, 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, 2.5-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 pacing/planning. 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults over age 18
- •Have chronic pain (pain on most days or everyday) for the past 3 months or more
- •Able to attend 1 CPSMP workshop a week over 6 weeks
- •Able to attend 3-4 testing sessions for data collection (testing sessions are scheduled before the workshops begin and then six months, one year and, for those assigned to the control group, one and a half years after the start of the study)
Exclusion Criteria
- •Chronic pain caused by current cancer diagnosis or an open wound
- •Lack reliable transportation
- •Having surgery for the painful area in the next year
- •Not community-dwelling (i.e., living in a nursing home, assisted living or personal care home, mental hospital, or correctional facility)
- •Not willing to be randomized to either start CPSMP workshop now or in six months
- •Participation in another self-management program (e.g., Diabetes Self-Management Program) in the past 12 months
- •Unable to speak English
Arms & Interventions
CPSMP Intervention
Participants randomly assigned to this arm will, following a baseline assessment, immediately begin attending a 6-week Chronic Pain Self-Management Program (CPSMP) workshop.
Intervention: Chronic Pain Self-Management Program (CPSMP) (Behavioral)
Wait-list Control Group
Participants assigned to this arm will wait six months after a baseline assessment and then attend the 6-week Chronic Pain Self-Management Program (CPSMP) workshop.
Intervention: Chronic Pain Self-Management Program (CPSMP) (Behavioral)
Outcomes
Primary Outcomes
Pain severity
Time Frame: Change between baseline and 52 weeks
Using Stanford's 0-10 Pain Visual Numeric Scale participants will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Defense and Veterans Pain Rating Scale
Time Frame: Change between baseline and 52 weeks
Using the Defense and Veterans Pain Rating Scale will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Secondary Outcomes
- Pain interference with sleep(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Pain frequency(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Perceived disability(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Pain avoidance(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Opioid misuse(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Medication Usage(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Mood(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Anxiety(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Catastrophizing(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Mindfulness(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Pain Self-Efficacy(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Coping(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Activation(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- General Health Status(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Vitality(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Minutes of Physical Activity(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
- Healthcare Utilization(Monthly for up to 12 months)
- Work(Monthly for up to 12 months)
- Gait speed(Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.)
Investigators
Dina L Jones, PT, PhD
Professor
West Virginia University