Evaluating the Manage My Pain App in Pain Clinics

January 30, 2024 updated by: University of Alberta

Chronic Pain is one of the most common reasons adults seek medical care, and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety and depression, and poor perceived health or reduced quality of life. Chronic Pain Clinics are an effective solution, however, the resources available and investments have fallen behind the growing needs of patients. Local waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting. Tools and technology that can help patients and healthcare providers understand and manage the patients' pain are needed for the effectiveness of the healthcare system.

In response to this problem, the Manage My Pain (MMP) App, which allows patients to log daily reflections of functionality, pain, and medication use; as well as, provide educational resources is a potential support for patients on the waitlist. This log is intended to support the patient understanding and management of their pain, and share their reports with their circle of care.

This study will assess the impact of MMP on waitlist patients' health outcomes compared to a control group of waitlist patients over 60 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic Pain is one of the most common reasons adults seek medical care and has been linked to restrictions in mobility and daily activities, dependence on opioids, anxiety, depression, and poor perceived health or reduced quality of life. Currently, local pain clinic waitlists have thousands of patients with wait times between 1 to 3 years, with many receiving little to no specialized support while waiting for an appointment. To address this problem, this study assesses the impact of the MMP App to support the health and medication use of patients on the waitlist. Using this approach patients on the waitlist can use this app to report their pain, functionality, reflections, and medication use, as well as read educational resources about pain management.

This study tests the effectiveness of the MMP App versus a control group (i.e., standard practice) on health outcomes and mediation use over 60 days in a randomized control trial (RCT). The primary outcomes are pain, anxiety, pain self-efficacy, and quality of life. Secondary outcome is medication usage. Researchers will use descriptive and regression analysis to assess the data collected.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Calgary Chronic Pain Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older
  • On the Calgary Pain Clinic waitlist

Exclusion Criteria:

  • Participants were excluded if they did not meet any of the above criteria
  • Patients declining or unable to complete the consent process for the study
  • No internet access
  • No access to a device or computer to display the app/website

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manage My Pain App Intervention
Participants will have access to the MMP App and standard care for 60 days.
Other: Manage My Pain App
This digital application helps patients measure, track, and manage chronic pain, functionality, and medication use. MMP can also be used to share patient pain experiences with their circle of care via reports and offers educational resources for patients.
No Intervention: Control Group
Participants will engage in standard care for 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQol-5 Dimension-5 Levels (EQ5D5L)
Time Frame: 60 days
EQ5D5L is a short descriptive questionnaire and a visual analogue scale that are simple to complete and assess five dimensions of quality of life including: mobility, selfcare, usual activities, pain/discomfort, and anxiety and depression (EuroQol, 2019). Each quality of life dimension will be assessed according to the following five level response scale, which varies in degree of severity from: no problem, light problem, moderate problems, severe problems, and unable to / extreme problems (EuroQol, 2019). The respondent will be asked to select the response item that most appropriately matches their current state (EuroQol, 2019). The single item score for each dimension is used assess the dimension, rather than a composite score. This instrument has been proven to be valid, reliable, and responsive in numerous conditions and populations (EuroQol, 2019; Finch et al., 2018).
60 days
Generalized Anxiety Disorder (GAD-7)
Time Frame: 60 days
The GAD-7 is a brief self-report assessment of anxiety severity for clinical practice and research (Spitzer et al., 2006). The GAD-7 consists of 7-items assessing anxiety on a four-point scale with response options including: not at all (score=0), several days (score=1), more than half the days (score=2), and nearly every day (score=3). To obtain the GAD-7 score, all scores are added to develop a total anxiety score. A score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and a score greater than 15 = severe anxiety (Plummer et al., 2016). To screen for anxiety disorders, a score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder (Plummer, et al 2016). The GAD-7 has been demonstrated to be a reliable and valid tool to detect generalized anxiety (Spitzer et al., 2006).
60 days
Pain (Numeric Pain Rating Scale)
Time Frame: 60 days
The Pain Numeric Rating Scale (NRS) is an 11 point scale that asks patients to identify the number between 0 (no pain at all) and 10 (the worst pain ever possible) that fits their pain intensity (McCaffery & Beebe, 1989).
60 days
Pain self-efficacy (PSEQ-4)
Time Frame: 60 days
PSEQ-4 is an instrument to assess pain self-efficacy for clinical and research purposes (Chiarotto et al., 2016). The PSEQ-4 includes four items scored on a 7-point Likert scale ranging from not at all confident (score=0) to completely confident (score=6). Pain self-efficacy is calculated by summing the scores to determine a total score ranging from 0 to 24 (Chiarotto et al., 2016). High scores indicate greater pain self-efficacy. A systematic review has found that the PSEQ-4 has demonstrated excellent validity, reliability, and responsiveness among chronic lower back pain patients (Dubé et al., 2021). The PSEQ-4 may replace the full PSEQ and have similar responsiveness (Chiarotto et al., 2016).
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Usage
Time Frame: 60 days
A medication usage questionnaire used in pain clinics was modified with clinicians for this study. The survey asks if any of the listed medication (i.e.,Tramadol, Acetaminophen/ Codeine (Tylenol No 3, Hydromorphone, Hydromorphone Contin, Oxycodone 5mg/ Acetaminophen 325mg (Percocet), Oxycodone 5mg/Naloxone 10mg (Targin), Oxycodone, Oxycontin, Codeine, Morphine, Morphine Contin, Oxycodone, Oxycontin, Methadone, Fentanyl, Buprenorphine, Other Opioid) were taken in the last 7 days. If the medication was taken, the dose and frequency of administration was recorded.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Alberta Health services
Ontario Bioscience Innovation Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00126058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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