A Community-Based Chronic Pain Self-Management Program in West Virginia

NCT03582683 | Completed

• 1 other identifier: 3U48DP005004-04S1
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain

Keywords

Self-Management Programs; Behavioral Health

Outcome Measures

Primary Outcomes (2)

• Pain severity

  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).

  Change between baseline and 52 weeks

• Defense and Veterans Pain Rating Scale

  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).

  Change between baseline and 52 weeks

Secondary Outcomes (19)

• 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.

Study Arms (2)

CPSMP Intervention

EXPERIMENTAL

Participants randomly assigned to this arm will, following a baseline assessment, immediately begin attending a 6-week Chronic Pain Self-Management Program (CPSMP) workshop.

Behavioral: Chronic Pain Self-Management Program (CPSMP)

Wait-list Control Group

ACTIVE COMPARATOR

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.

Behavioral: Chronic Pain Self-Management Program (CPSMP)

Interventions

Chronic Pain Self-Management Program (CPSMP) BEHAVIORAL

Stanford University's Chronic Pain Self-Management Program (CPSMP) was developed by Sandra LeFort in 1996 and based on Stanford's Arthritis Self-Management Program and the Chronic Disease Self-Management Program. The 6-week community-delivered workshop consists of 2.5-hour weekly sessions for people with a primary or secondary diagnosis of Chronic Pain.

CPSMP Intervention; Wait-list Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• Centers for Disease Control and Prevention: collaborator
• West Virginia School of Osteopathic Medicine: collaborator
• Mid-Ohio Valley Health Department: collaborator

Study Sites (2)

West Virginia School of Osteopathic Medicine

Lewisburg, West Virginia, 24901, United States

Location

Mid-Ohio Valley Health Department

Parkersburg, West Virginia, 26101, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 11, 2018
• Study Start: June 18, 2018
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

US (2)