Clinical trial NCT03582683: A Community-Based Chronic Pain Self-Management Program in West Virginia
Official title: A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Self-Management Programs
Behavioral Health
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: West Virginia School of Osteopathic Medicine
name: Mid-Ohio Valley Health Department
First posted: 2018-07-11
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After a baseline assessment, participants will be randomized to the CPSMP intervention or a 6-month, wait-list control group based on an allocation sequence based on class size, that will be stratified by site and allocated via opaque envelopes.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain severity
timeFrame: Change between baseline and 52 weeks
measure: Defense and Veterans Pain Rating Scale
timeFrame: Change between baseline and 52 weeks
Secondary outcomes:
measure: Pain interference with sleep
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Pain frequency
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Perceived disability
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Pain avoidance
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Opioid misuse
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Medication Usage
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Mood
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Anxiety
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Catastrophizing
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Mindfulness
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Pain Self-Efficacy
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Coping
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Activation
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: General Health Status
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Vitality
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Minutes of Physical Activity
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
measure: Healthcare Utilization
timeFrame: Monthly for up to 12 months
measure: Work
timeFrame: Monthly for up to 12 months
measure: Gait speed
timeFrame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Other outcomes:
Locations:
city: Lewisburg
country: United States
facility: West Virginia School of Osteopathic Medicine
state: West Virginia
city: Parkersburg
country: United States
facility: Mid-Ohio Valley Health Department
state: West Virginia
Study officials:
References: