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Manage My Pain at Chronic Pain Clinics

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Manage My Pain (MMP) digital pain app group
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain focused on measuring Pain, Psychology, Patient Oriented Research, Quality of Life, Digital Health, Chronic Pain, Pain App, Virtual Care, mHealth, Pain Management, Chronic Disease Management, Remote Monitoring

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

Patient group using paper format for pain data

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2020
Last Updated
February 16, 2021
Sponsor
University Health Network, Toronto
Collaborators
Ontario Centres of Excellence
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1. Study Identification

Unique Protocol Identification Number
NCT04762329
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Ontario Centres of Excellence

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient group using Manage My Pain (MMP) digital application for pain data
Arm Type
Experimental
Arm Description
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
Arm Title
Patient group using paper format for pain data
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manage My Pain (MMP) digital pain app group
Intervention Description
To evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting
Primary Outcome Measure Information:
Title
Evaluating engagement based on adoption and retention rates
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in depression as measured by the Patient Health Questionnaire 9-item (PHQ-9)
Time Frame
Short-term (4.5 months) and long-term (4.5-7 months)
Title
Change in anxiety as measured by the General Anxiety Disorder 7-item Questionnaire (GAD-7)
Time Frame
Short-term (4.5 months) and long-term (4.5-7 months)
Title
Change in pain disability as measured by the Pain Disability Index (PDI)
Time Frame
Short-term (4.5 months) and long-term (4.5-7 months)
Title
Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS)
Time Frame
Short-term (4.5 months) and long-term (4.5-7 months)
Title
Change in opioid consumption as measured by Oral Morphine Equivalents (OME)
Time Frame
Short-term (4.5 months) and long-term (4.5-7 months)
Title
Change in patient satisfaction as measured by the Patient Global Impression of Change (PGIC) scale
Time Frame
Short-term (4.5 months) and long-term (4.5-7 months)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD was collected during the study to share
Citations:
PubMed Identifier
27583140
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.
Results Reference
background
PubMed Identifier
27713649
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.
Results Reference
background
PubMed Identifier
30361196
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.
Results Reference
background
PubMed Identifier
33661130
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.
Results Reference
derived

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Manage My Pain at Chronic Pain Clinics

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