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

9 aprile 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

196

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain severity
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain interference with sleep
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Monthly for up to 12 months
Emergency room visits and doctor/clinic visits
Monthly for up to 12 months
Work
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

West Virginia University

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 giugno 2018

Completamento primario (Effettivo)

9 aprile 2021

Completamento dello studio (Effettivo)

9 aprile 2021

Date di iscrizione allo studio

Primo inviato

14 giugno 2018

Primo inviato che soddisfa i criteri di controllo qualità

27 giugno 2018

Primo Inserito (Effettivo)

11 luglio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 aprile 2021

Ultimo verificato

1 aprile 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 3U48DP005004-04S1 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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