Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN (Shared-Care)
29. April 2022 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
240
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Patricia Poulin, PhD C. Psych
- Telefonnummer: 73903 6137378899
- E-Mail: ppoulin@toh.ca
Studienorte
-
-
Ontario
-
Ottawa, Ontario, Kanada, K1H8L6
- Ottawa Hospital Research Institute
-
-
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:
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in pain intensity, as measured by the Brief Pain Inventory.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Patricia Poulin, PhD C. Psych, Ottawa Hospital Research Institute
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 (Voraussichtlich)
1. September 2022
Primärer Abschluss (Voraussichtlich)
1. März 2023
Studienabschluss (Voraussichtlich)
1. März 2023
Studienanmeldedaten
Zuerst eingereicht
19. März 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. Mai 2018
Zuerst gepostet (Tatsächlich)
21. Mai 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. Mai 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. April 2022
Zuletzt verifiziert
1. April 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20180238-01H
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
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 .