Manage My Pain at Chronic Pain Clinics

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT04762329
Collaborator
Ontario Centres of Excellence (Industry)
246
1
2
27
9.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Manage My Pain (MMP) digital pain app group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
246 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Manage My Pain at Chronic Pain Clinics in Urban, Community, and Rural Hospitals
Actual Study Start Date :
Jan 8, 2018
Actual Primary Completion Date :
Jan 8, 2020
Actual Study Completion Date :
Apr 8, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluating engagement based on adoption and retention rates [24 months]

    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

  1. 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)]

  2. 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)]

  3. Change in pain disability as measured by the Pain Disability Index (PDI) [Short-term (4.5 months) and long-term (4.5-7 months)]

  4. Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS) [Short-term (4.5 months) and long-term (4.5-7 months)]

  5. Change in opioid consumption as measured by Oral Morphine Equivalents (OME) [Short-term (4.5 months) and long-term (4.5-7 months)]

  6. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto
  • Ontario Centres of Excellence

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04762329
Other Study ID Numbers:
  • 17-6201
First Posted:
Feb 21, 2021
Last Update Posted:
Feb 21, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2021