Clinical trial NCT04762329: Manage My Pain at Chronic Pain Clinics
Official title: Manage My Pain at Chronic Pain Clinics in Urban, Community, and Rural Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Pain
Psychology
Patient Oriented Research
Quality of Life
Digital Health
Chronic Pain
Pain App
Virtual Care
mHealth
Pain Management
Chronic Disease Management
Remote Monitoring
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Centres of Excellence
First posted: 2021-02-21
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluating engagement based on adoption and retention rates
timeFrame: 24 months
Secondary outcomes:
measure: Change in depression as measured by the Patient Health Questionnaire 9-item (PHQ-9)
timeFrame: Short-term (4.5 months) and long-term (4.5-7 months)
measure: Change in anxiety as measured by the General Anxiety Disorder 7-item Questionnaire (GAD-7)
timeFrame: Short-term (4.5 months) and long-term (4.5-7 months)
measure: Change in pain disability as measured by the Pain Disability Index (PDI)
timeFrame: Short-term (4.5 months) and long-term (4.5-7 months)
measure: Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS)
timeFrame: Short-term (4.5 months) and long-term (4.5-7 months)
measure: Change in opioid consumption as measured by Oral Morphine Equivalents (OME)
timeFrame: Short-term (4.5 months) and long-term (4.5-7 months)
measure: Change in patient satisfaction as measured by the Patient Global Impression of Change (PGIC) scale
timeFrame: Short-term (4.5 months) and long-term (4.5-7 months)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.