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Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN (Shared-Care)

29. april 2022 oppdatert av: Ottawa Hospital Research Institute
The study is evaluating an intervention consisting of a five week online mindfulness program for patients being referred to the Pain Clinic and triaged to eConsult. A pain specialist will be in contact with the patient's family physician to confirm it's appropriate and then a therapist will initiate contact with the patient to assess eligibility. The therapist will be a registered health professional with experience with patients with chronic health problems and will be supporting the online program where the participant will have communication access to them. Questionnaires will be sent at three time points to assess changes.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

There are currently many patients waiting to be seen at The Ottawa Hospital Pain Clinic (TOHPC). However, many patients with chronic pain (CP) have exhausted medical options or could be served in the community with appropriate support for them and their family physicians (FPs). eConsult is a secure web-based platform that allows TOHPC physicians to provide pain management advice within seven days within the Champlain Local Health Integration Network (LHIN).

In order to provide enhanced care to patients and improve the uptake of eConsult for CP, the investigators have developed a shared care model for CP in the Champlain LHIN. This program combines the use of eConsult for FPs and a 5-week self-directed online CP management program with therapist support available as needed.

Studietype

Intervensjonell

Registrering (Forventet)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Patricia Poulin, PhD C. Psych
  • Telefonnummer: 73903 6137378899
  • E-post: ppoulin@toh.ca

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • Ottawa Hospital Research Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • aged 18-years or older
  • ability to understand oral and written English
  • report chronic pain (≥3months)

Exclusion Criteria:

  • refusal or inability to provide informed consent
  • severe, unstable or untreated psychiatric conditions (ex. severe depression, psychosis, bipolar, etc.)
  • does not have access to the internet or electronic device capable of watching videos

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Online chronic pain management program
There is only one arm. Those who consent to participate in the study and take the online self-directed chronic pain management program with therapist support.
Atferdsmessig: Online Chronic Pain Management Program
With the support of a study therapist, the participant will be enrolled in a 5 week self-directed pain management program. The study therapist is a registered health professional. The program will consist of 5 weeks of mindfulness training. The mindfulness training focuses on the basics of mindfulness-based interventions including body, emotions, sensations, thoughts, compassion, pain and stress management.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The interference scale measures the degree to which pain interferes in the lives of participants in 7 domains: general activity, mood, walking ability, normal work, relations with other persons, sleep and enjoyment of life on a scale from 0 to 10. The higher the score, the greater the pain interferes with patient's activities.This is a well-validated measure of pain-related disability. The minimum clinically significant difference is 1 point.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in pain intensity, as measured by the Brief Pain Inventory.
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The Brief Pain Inventory (BPI) Pain Severity Scale measures the severity of pain one feels at worst, at least, on average, and at the time of questionnaire completion on a scale from 0 to 10. The higher the score, the greater the pain severity.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Mindfulness will be measured using the Short Form Five Facet Mindfulness Questionnaire (FFMQ-SF). The FFMQ-SF is a 24-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Change in quality of life, as measured by the EuroQOL-5D
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The EuroQOL-5D (EQ-5D) is a simple-to-use, valid, and sensitive instrument measuring quality of life. It covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, or severe problems and participants use a tick box to select the statement that is most representative of their conditions. Participants are also asked to rate, using a visual analogue scale (0 to 100), their state of health.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item scale used to assess the severity of depressive symptoms over the past two weeks and is based on Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for major depression. Total scores range from 0 to 27, and clinical cut-points correspond to mild, moderate, moderately severe, and severe depression.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Overall change in status from baseline, as measured by Patient Global Impression of Change scale
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The participants' perceived degree of change in overall status will be measured using the Patient Global Impression of Change (PGIC) scale. The PGIC uses a 7-point likert scale (very much worse, to very much better) to measure how much the participant feels their overall status has changed since the start of the study.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7
Tidsramme: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
The Generalized Anxiety Disorder - 7 (GAD-7) is a 7-item scale used to assess the severity of anxiety symptoms over the past two weeks. Total scores range from 0 to 15, and clinical cut-points correspond to mild, moderate, and severe anxiety.
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ottawa Hospital Research Institute

Etterforskere

  • Hovedetterforsker: Patricia Poulin, PhD C. Psych, Ottawa Hospital Research Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. september 2022

Primær fullføring (Forventet)

1. mars 2023

Studiet fullført (Forventet)

1. mars 2023

Datoer for studieregistrering

Først innsendt

19. mars 2018

Først innsendt som oppfylte QC-kriteriene

8. mai 2018

Først lagt ut (Faktiske)

21. mai 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20180238-01H

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