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

9. April 2021 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

196

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Aktiver 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain severity
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain interference with sleep
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Monthly for up to 12 months
Emergency room visits and doctor/clinic visits
Monthly for up to 12 months
Work
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

West Virginia University

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Juni 2018

Primärer Abschluss (Tatsächlich)

9. April 2021

Studienabschluss (Tatsächlich)

9. April 2021

Studienanmeldedaten

Zuerst eingereicht

14. Juni 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Juni 2018

Zuerst gepostet (Tatsächlich)

11. Juli 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. April 2021

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 3U48DP005004-04S1 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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