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

29 kwietnia 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

240

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Patricia Poulin, PhD C. Psych
  • Numer telefonu: 73903 6137378899
  • E-mail: ppoulin@toh.ca

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in pain intensity, as measured by the Brief Pain Inventory.
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ottawa Hospital Research Institute

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 września 2022

Zakończenie podstawowe (Oczekiwany)

1 marca 2023

Ukończenie studiów (Oczekiwany)

1 marca 2023

Daty rejestracji na studia

Pierwszy przesłany

19 marca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 maja 2018

Pierwszy wysłany (Rzeczywisty)

21 maja 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 maja 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 kwietnia 2022

Ostatnia weryfikacja

1 kwietnia 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20180238-01H

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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