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

Primary Purpose

Chronic Pain, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online Chronic Pain Management Program
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Mindfulness, Chronic Pain, Disability, Quality of Life, Online

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Hospital Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Online chronic pain management program

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
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.

Secondary Outcome Measures

Change in pain intensity, as measured by the Brief Pain Inventory.
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.
Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
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).
Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
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.
Change in quality of life, as measured by the EuroQOL-5D
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.
Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale
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.
Overall change in status from baseline, as measured by Patient Global Impression of Change scale
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.
Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7
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.

Full Information

First Posted
March 19, 2018
Last Updated
April 29, 2022
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03531476
Brief Title
Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN
Acronym
Shared-Care
Official Title
Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Quality of Life
Keywords
Mindfulness, Chronic Pain, Disability, Quality of Life, Online

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online chronic pain management program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Chronic Pain Management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Secondary Outcome Measure Information:
Title
Change in pain intensity, as measured by the Brief Pain Inventory.
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Title
Change in pain catastrophizing, as measured by the Pain Catastrophizing Scale
Description
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).
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Title
Change in mindfulness, as measured by the Short Form Five Facet Mindfulness Questionnaire.
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Title
Change in quality of life, as measured by the EuroQOL-5D
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Title
Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Title
Overall change in status from baseline, as measured by Patient Global Impression of Change scale
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Title
Change from baseline in anxiety symptoms, as measured by the Generalized Anxiety Disorder-7
Description
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.
Time Frame
At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Poulin, PhD C. Psych
Phone
6137378899
Ext
73903
Email
ppoulin@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Poulin, PhD C. Psych
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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