Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582683
Recruitment Status : Active, not recruiting
First Posted : July 11, 2018
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
West Virginia School of Osteopathic Medicine
Mid-Ohio Valley Health Department
Information provided by (Responsible Party):
Dina L Jones, PT, PhD, West Virginia University

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Chronic Pain Self-Management Program (CPSMP) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: 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.
Behavioral: Chronic Pain Self-Management Program (CPSMP)
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.

Active Comparator: 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.
Behavioral: Chronic Pain Self-Management Program (CPSMP)
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.




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. Pain interference with sleep [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Defense and Veterans Pain Rating Scale Supplemental Question (revised from 24 hours to past 2 weeks)

  2. Pain frequency [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    2016 NHIS (past 3 months)

  3. Perceived disability [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Pain Disability Index

  4. Pain avoidance [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Tampa Scale of Kinesiophobia. A total score is calculated that ranges from 17 (low degree of kinesiophobia) to 68 (a high degree of kinesiophobia)

  5. Opioid misuse [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Screener and Opioid Assessment for Patients with Pain (SOAPP) v1.0-SF

  6. Medication Usage [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Morphine milligram equivalents (MME) per day of current prescription or over-the-counter medications for pain, depression, anxiety, mood, or sleep (also usage of stimulants and muscle relaxers)

  7. Mood [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Stanford Personal Health Questionnaire-Depression (PHQ-8)

  8. Anxiety [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Generalized Anxiety Disorder-7 (GAD-7)

  9. Catastrophizing [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Pain Catastrophizing Scale. The total score ranges from 0 (low catastrophizing) to 52 (high catastrophizing). There are 3 subscales (rumination, magnification, and helplessness)

  10. Mindfulness [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    5 Facet Mindfulness Questionnaire Short Form

  11. Pain Self-Efficacy [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Pain Self-Efficacy Scale. The total score ranges from 0 (low self-efficacy) to 60 (high self-efficacy)

  12. Coping [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Coping Strategies Questionnaire-Revised

  13. Activation [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    Patient Activation Measure

  14. General Health Status [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    2016 BRFSS question

  15. Vitality [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    SF-36 v1

  16. Minutes of Physical Activity [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    2016 NHIS questions

  17. Healthcare Utilization [ Time Frame: Monthly for up to 12 months ]
    Emergency room visits and doctor/clinic visits

  18. Work [ Time Frame: Monthly for up to 12 months ]
    Number of days missed work and number of days in bed more than half of the day

  19. Gait speed [ Time Frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start. ]
    5- or 10-meter gait speed test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582683


Locations
Layout table for location information
United States, West Virginia
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, United States, 24901
Mid-Ohio Valley Health Department
Parkersburg, West Virginia, United States, 26101
Sponsors and Collaborators
West Virginia University
Centers for Disease Control and Prevention
West Virginia School of Osteopathic Medicine
Mid-Ohio Valley Health Department

Layout table for additonal information
Responsible Party: Dina L Jones, PT, PhD, Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT03582683     History of Changes
Other Study ID Numbers: 3U48DP005004-04S1 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina L Jones, PT, PhD, West Virginia University:
Self-Management Programs
Behavioral Health
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms