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

29 avril 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

240

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Patricia Poulin, PhD C. Psych
  • Numéro de téléphone: 73903 6137378899
  • E-mail: ppoulin@toh.ca

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in pain intensity, as measured by the Brief Pain Inventory.
Délai: 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
Délai: 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.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ottawa Hospital Research Institute

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 septembre 2022

Achèvement primaire (Anticipé)

1 mars 2023

Achèvement de l'étude (Anticipé)

1 mars 2023

Dates d'inscription aux études

Première soumission

19 mars 2018

Première soumission répondant aux critères de contrôle qualité

8 mai 2018

Première publication (Réel)

21 mai 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2022

Dernière vérification

1 avril 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20180238-01H

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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