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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04762329
Other study ID # 17-6201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2018
Est. completion date April 8, 2020

Study information

Verified date February 2021
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 246
Est. completion date April 8, 2020
Est. primary completion date January 8, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Toronto Western Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Ontario Centres of Excellence

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Alexander JC, Joshi GP. Smartphone applications for chronic pain management: a critical appraisal. J Pain Res. 2016 Sep 26;9:731-734. eCollection 2016. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary Change in pain disability as measured by the Pain Disability Index (PDI) Short-term (4.5 months) and long-term (4.5-7 months)
Secondary Change in pain catastrophizing and measured by the Pain Catastrophizing Scale (PCS) Short-term (4.5 months) and long-term (4.5-7 months)
Secondary Change in opioid consumption as measured by Oral Morphine Equivalents (OME) Short-term (4.5 months) and long-term (4.5-7 months)
Secondary 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)
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