Evaluating the Manage My Pain App in Pain Clinics

NCT ID: NCT05946239

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial (RCT) using quantitative approaches will be undertaken to assess the impact of MMP on chronic pain clinic waitlist patient health outcomes prior to attending their first pain clinic appointment. This study will have 1 intervention group (access to MMP + standard care) and 1 control group (standard care). Participants will be randomly assigned to the intervention group or control group at a 2:1 ratio to account for variations in App usage.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Manage My Pain App Intervention

Participants will have access to the MMP App and standard care for 60 days.

Group Type EXPERIMENTAL

Manage My Pain App

Intervention Type OTHER

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.

Control Group

Participants will engage in standard care for 60 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ontario Bioscience Innovation Organization

UNKNOWN

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Calgary Chronic Pain Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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Chiarotto A, Vanti C, Cedraschi C, Ferrari S, de Lima E Sa Resende F, Ostelo RW, Pillastrini P. Responsiveness and Minimal Important Change of the Pain Self-Efficacy Questionnaire and Short Forms in Patients With Chronic Low Back Pain. J Pain. 2016 Jun;17(6):707-18. doi: 10.1016/j.jpain.2016.02.012. Epub 2016 Mar 11.

Reference Type BACKGROUND
PMID: 26975193 (View on PubMed)

Dube MO, Langevin P, Roy JS. Measurement properties of the Pain Self-Efficacy Questionnaire in populations with musculoskeletal disorders: a systematic review. Pain Rep. 2021 Dec 21;6(4):e972. doi: 10.1097/PR9.0000000000000972. eCollection 2021 Nov-Dec.

Reference Type BACKGROUND
PMID: 34963996 (View on PubMed)

Finch AP, Brazier JE, Mukuria C. What is the evidence for the performance of generic preference-based measures? A systematic overview of reviews. Eur J Health Econ. 2018 May;19(4):557-570. doi: 10.1007/s10198-017-0902-x. Epub 2017 May 30.

Reference Type BACKGROUND
PMID: 28560520 (View on PubMed)

Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

Reference Type BACKGROUND
PMID: 16320034 (View on PubMed)

Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016 Mar-Apr;39:24-31. doi: 10.1016/j.genhosppsych.2015.11.005. Epub 2015 Nov 18.

Reference Type BACKGROUND
PMID: 26719105 (View on PubMed)

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

Reference Type BACKGROUND
PMID: 16717171 (View on PubMed)

Pain: clinical manual for nursing practice Pain: clinical manual for nursing practice Margo McCaffery Alexander Beebe Mosby Yearbook UK pound17.25 0 7234 1992 2. Nurs Stand. 1994 Dec 7;9(11):55. doi: 10.7748/ns.9.11.55.s69.

Reference Type BACKGROUND
PMID: 27527475 (View on PubMed)

Related Links

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https://euroqol.org/publications/user-guides/

EuroQol Research Foundation. (2019). EQ5D5L User Guide

Other Identifiers

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Pro00126058

Identifier Type: -

Identifier Source: org_study_id

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