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

perjantai 9. huhtikuuta 2021 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

196

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Muut
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: 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.
Käyttäytyminen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Pain severity
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Pain interference with sleep
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Monthly for up to 12 months
Emergency room visits and doctor/clinic visits
Monthly for up to 12 months
Work
Aikaikkuna: 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
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

West Virginia University

Yhteistyökumppanit

Centers for Disease Control and Prevention
West Virginia School of Osteopathic Medicine
Mid-Ohio Valley Health Department

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 18. kesäkuuta 2018

Ensisijainen valmistuminen (Todellinen)

Perjantai 9. huhtikuuta 2021

Opintojen valmistuminen (Todellinen)

Perjantai 9. huhtikuuta 2021

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 14. kesäkuuta 2018

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 27. kesäkuuta 2018

Ensimmäinen Lähetetty (Todellinen)

Keskiviikko 11. heinäkuuta 2018

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 12. huhtikuuta 2021

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 9. huhtikuuta 2021

Viimeksi vahvistettu

Torstai 1. huhtikuuta 2021

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 3U48DP005004-04S1 (Yhdysvaltain NIH-apuraha/sopimus)

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset Krooninen kipu

Kliiniset tutkimukset Chronic Pain Self-Management Program (CPSMP)

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