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

NCT03531476 | Unknown

• 1 other identifier: 20180238-01H
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Quality of Life

Keywords

Mindfulness; Chronic Pain; Disability; Quality of Life; Online

Outcome Measures

Primary Outcomes (1)

• 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.

  At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

Secondary Outcomes (7)

• Change in pain intensity, as measured by the Brief Pain Inventory.

  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

  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.

  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

  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

  At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program

Study Arms (1)

Online chronic pain management program

EXPERIMENTAL

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.

Behavioral: Online Chronic Pain Management Program

Interventions

Online Chronic Pain Management Program BEHAVIORAL

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.

Online chronic pain management program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Poulin, PhD C. Psych

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Poulin, PhD C. Psych

CONTACT

6137378899; ppoulin@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: May 21, 2018
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)