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

9. april 2021 opdateret af: Dina L Jones, PT, PhD, West Virginia University

A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

196

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • West Virginia
      • Lewisburg, West Virginia, Forenede Stater, 24901
        • West Virginia School of Osteopathic Medicine
      • Parkersburg, West Virginia, Forenede Stater, 26101
        • Mid-Ohio Valley Health Department

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Aktiv komparator: 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.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain severity
Tidsramme: 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).
Change between baseline and 52 weeks
Defense and Veterans Pain Rating Scale
Tidsramme: 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).
Change between baseline and 52 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain interference with sleep
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain frequency
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Perceived disability
Tidsramme: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain Disability Index
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain avoidance
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Opioid misuse
Tidsramme: 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
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Medication Usage
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mood
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Anxiety
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Catastrophizing
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mindfulness
Tidsramme: 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
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain Self-Efficacy
Tidsramme: 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)
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Coping
Tidsramme: 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
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Activation
Tidsramme: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Patient Activation Measure
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
General Health Status
Tidsramme: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
2016 BRFSS question
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Vitality
Tidsramme: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
SF-36 v1
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
Tidsramme: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
2016 NHIS questions
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Healthcare Utilization
Tidsramme: Monthly for up to 12 months
Emergency room visits and doctor/clinic visits
Monthly for up to 12 months
Work
Tidsramme: Monthly for up to 12 months
Number of days missed work and number of days in bed more than half of the day
Monthly for up to 12 months
Gait speed
Tidsramme: 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
Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. juni 2018

Primær færdiggørelse (Faktiske)

9. april 2021

Studieafslutning (Faktiske)

9. april 2021

Datoer for studieregistrering

Først indsendt

14. juni 2018

Først indsendt, der opfyldte QC-kriterier

27. juni 2018

Først opslået (Faktiske)

11. juli 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 3U48DP005004-04S1 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Kronisk smerte

Kliniske forsøg med Chronic Pain Self-Management Program (CPSMP)

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