NCT04762329

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

October 26, 2020

Last Update Submit

March 24, 2025

Conditions

Keywords

PainPsychologyPatient Oriented ResearchQuality of LifeDigital HealthChronic PainPain AppVirtual CaremHealthPain ManagementChronic Disease ManagementRemote Monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

Patient group using Manage My Pain (MMP) digital application for pain data

EXPERIMENTAL

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

Patient group using paper format for pain data

NO INTERVENTION

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.

Interventions

To evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting

Patient group using Manage My Pain (MMP) digital application for pain data

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • New patients with chronic pain conditions referred to participating sites with pain programs to adopt the MMP tool into clinical practice.

You may not qualify if:

  • Patients declining to consent for the study
  • Patients withdrawing from the study at a later time after consenting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 27583140BACKGROUND
  • 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.

    PMID: 27713649BACKGROUND
  • 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.

    PMID: 30361196BACKGROUND
  • 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.

MeSH Terms

Conditions

Chronic PainPainAgnosia

Interventions

Matrix Metalloproteinases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2020

First Posted

February 21, 2021

Study Start

January 8, 2018

Primary Completion

January 8, 2020

Study Completion

April 8, 2020

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

No IPD was collected during the study to share

Locations