Manage My Pain at Chronic Pain Clinics

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Manage My Pain (MMP) digital pain app group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient group using Manage My Pain (MMP) digital application for pain data; 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; To evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting
No Intervention: Patient group using paper format for pain data; 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?

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	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)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Ontario Centres of Excellence

Publications and helpful links

General Publications

• Portelli P, Eldred C. A quality review of smartphone applications for the management of pain. Br J Pain. 2016 Aug;10(3):135-40. doi: 10.1177/2049463716638700. Epub 2016 Apr 19.
• Alexander JC, Joshi GP. Smartphone applications for chronic pain management: a critical appraisal. J Pain Res. 2016 Sep 26;9:731-734. doi: 10.2147/JPR.S119966. eCollection 2016. No abstract available.
• Salazar A, de Sola H, Failde I, Moral-Munoz JA. Measuring the Quality of Mobile Apps for the Management of Pain: Systematic Search and Evaluation Using the Mobile App Rating Scale. JMIR Mhealth Uhealth. 2018 Oct 25;6(10):e10718. doi: 10.2196/10718.
• Bhatia A, Kara J, Janmohamed T, Prabhu A, Lebovic G, Katz J, Clarke H. User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26528. doi: 10.2196/26528.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): April 8, 2020

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Pain; Chronic Pain; mHealth; Digital Health; Remote Monitoring; Pain Management; Chronic Disease Management; Psychology; Virtual Care; Patient Oriented Research; Pain App
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 17-6201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD was collected during the study to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No