Clinical trial NCT05946239: Evaluating the Manage My Pain App in Pain Clinics
Official title: Evaluating the Manage My Pain App in Pain Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain management
digital health
communication
quality of life
chronic pain
psychology
chronic disease management
anxiety
medication usage
patient oriented research
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Ontario Bioscience Innovation Organization
name: Alberta Health services
First posted: 2023-07-14
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: EuroQol-5 Dimension-5 Levels (EQ5D5L)
timeFrame: 60 days
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 60 days
measure: Pain (Numeric Pain Rating Scale)
timeFrame: 60 days
measure: Pain self-efficacy (PSEQ-4)
timeFrame: 60 days
Secondary outcomes:
measure: Medication Usage
timeFrame: 60 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Calgary Chronic Pain Centre
state: Alberta
Study officials:
References:
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