Chronic PainShared-CareNCT03531476
Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN
A study testing Online Chronic Pain Management Program in people with Chronic Pain and Quality of Life, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Quality of Life
- What is being tested?
- Online Chronic Pain Management Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2022to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-years or older
- ability to understand oral and written English
- report chronic pain (≥3months)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Quality of Life
- Being tested
- Online Chronic Pain Management Program
- Keywords
- Mindfulness, Chronic Pain, Disability, Quality of Life, Online
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Chronic Pain Management ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Chronic Pain Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
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).
Measured: 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.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study startSep 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Poulin, PhD C. Psych, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531476
- Sponsor's protocol ID
- 20180238-01H
- Acronym
- Shared-Care
- Status last verified
- Apr 2022
- First submitted
- 19 Mar 2018
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Pilot Shard-care Program for Patients With Chronic Pain in the Champlain-LHIN
- ClinicalTrials.gov ID
- NCT03531476
- Acronym / sponsor ID
- Shared-Care / 20180238-01H
- Conditions
- Chronic Pain, Quality of Life
- Keywords
- Mindfulness, Chronic Pain, Disability, Quality of Life, Online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online chronic pain management program | Experimental | Behavioral: Online Chronic Pain Management ProgramThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-years or older
- ability to understand oral and written English
- report chronic pain (≥3months)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Chronic Pain Management ProgramWith 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. | Behavioural | Online chronic pain management program |
Primary outcome
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I)
Time frame: 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.
7 secondary outcomes
Change in pain intensity, as measured by the Brief Pain Inventory.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Poulin, PhD C. Psych principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Chronic Pain Management Program in people with Chronic Pain and Quality of Life, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Poulin, PhD C. Psych (6137378899 ext. 73903, ppoulin@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean score of the Brief Pain Inventory-Interference Scale (BPI-I) (time frame: At enrollment prior to the program, 2 weeks post-program, and at a 3-month follow-up after the program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.