Manage My Pain at Chronic Pain Clinics

Study Overview
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Brief Summary
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The overall objective of this Early Adoption project is to gather evidence for how Managing My Pain Program (MMP), a novel digital pain management application can enable better care at home for chronic pain sufferers in the province of Ontario, Canada across 4 sites in urban, community, and rural settings

Detailed Description
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Chronic pain imposes a large burden on individuals and society. A patient-centric digital chronic pain management application, Managing My Pain Program (MMP) that incorporates validated questionnaires can be used to enhance communication between providers and patients and promote self-management to evaluate the extent of patient engagement with the app when used in clinical settings. The main objectives for this project is to evaluate the engagement in patients using MMP, and to assess improvements in clinical outcomes directly relevant for pain management, as measured by clinically-validated tools.

Official Title
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Manage My Pain at Chronic Pain Clinics in Urban, Community, and Rural Hospitals

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: Manage My Pain (MMP) digital pain app group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New patients with chronic pain conditions referred to participating sites with pain programs to adopt the MMP tool into clinical practice. Exclusion Criteria: Patients declining to consent for the study Patients withdrawing from the study at a later time after consenting
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient group using Manage My Pain (MMP) digital application for pain data<br>Participants completed pain related questionnaires on the following pain related outcomes - anxiety, depression, catastrophizing, disability, patient impression of change, and daily opioid consumption at baseline on initial visit and as a part of the first follow-up clinical visits, on the Manage My Pain (MMP) digital application | Other: Manage My Pain (MMP) digital pain app group<br>* To evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting<br>|
| No Intervention: Patient group using paper format for pain data<br>Participants completed pain related questionnaires on the following pain related outcomes - anxiety, depression, catastrophizing, disability, patient impression of change, and daily opioid consumption at baseline on initial visit and as a part of the first follow-up clinical visits on paper format or phone interviews. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating engagement based on adoption and retention rates | Evaluating the number of patients who elected to use the Manage My Pain (MMP) application, and determining how long they used the app in the short-term (4.5 months) and long-term (4.5-7 months) follow-ups | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression as measured by the Patient Health Questionnaire 9-item (PHQ-9) |  | Short-term (4.5 months) and long-term (4.5-7 months) | 
| Change in anxiety as measured by the General Anxiety Disorder 7-item Questionnaire (GAD-7) |  | Short-term (4.5 months) and long-term (4.5-7 months) | 
| Change in pain disability as measured by the Pain Disability Index (PDI) |  | Short-term (4.5 months) and long-term (4.5-7 months) | 
| Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS) |  | Short-term (4.5 months) and long-term (4.5-7 months) | 
| Change in opioid consumption as measured by Oral Morphine Equivalents (OME) |  | Short-term (4.5 months) and long-term (4.5-7 months) | 
| Change in patient satisfaction as measured by the Patient Global Impression of Change (PGIC) scale |  | Short-term (4.5 months) and long-term (4.5-7 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Psychology, Patient Oriented Research, Quality of Life, Digital Health, Chronic Pain, Pain App, Virtual Care, mHealth, Pain Management, Chronic Disease Management, Remote Monitoring