EPIO App for Chronic Pain

(Flourish Trial)

Overseen By Eleshia J. Morrison, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Cancer pain, Severe untreated psychological illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called EPIO, designed to help people manage chronic pain using cognitive-behavioral techniques. The goal is to evaluate the app's effectiveness for Black and LGBTQ+ adults who have experienced chronic pain for at least three months and struggle with daily activities. Participants should reside in Minnesota, Wisconsin, or Iowa and must have a smartphone or tablet to use the app daily. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance chronic pain management for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an app for pain management, so you may not need to change your medication routine.

What prior data suggests that the EPIO App is safe for chronic pain management?

Research has shown that the EPIO app is generally safe for people with chronic pain. In a previous study, users reported no major negative effects, indicating the app was well-tolerated. Another study found that while the app didn't significantly change how pain affected daily life, it caused no harm. Overall, users experienced positive mental changes over time. This suggests that the app is safe and could help manage chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The EPIO App for chronic pain is unique because it leverages a digital platform to provide tailored pain management strategies. Unlike traditional treatments that often rely on medications or physical therapy, this app offers personalized coping mechanisms and cognitive-behavioral techniques directly through a smartphone. Researchers are excited about its potential to improve accessibility and engagement, especially for Black and LGBTQIA+ adults, groups that may experience disparities in healthcare access. This approach could lead to more inclusive and effective chronic pain management.

What evidence suggests that the EPIO App is effective for chronic pain?

Research has shown that the EPIO app, a digital tool for managing chronic pain, yields promising results. One study found that using EPIO for 12 months led to lasting improvements in pain management. Another study noted that the app helped reduce anxiety and the tendency to focus excessively on pain, which are often linked to chronic pain. Although some short-term results did not show major changes in how pain affects daily life, users reported benefits like reduced anxiety. Overall, EPIO appears to be an effective tool for managing chronic pain. This trial will specifically evaluate the EPIO app for Black adults and LGBTQIA+ adults with chronic pain to assess its effectiveness in these groups. ^{1 2 3 5 6}

Who Is on the Research Team?

Eleshia J. Morrison, Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for Black and LGBTQ+ adults who have been dealing with high-impact chronic pain that has lasted at least 3 months and disrupts daily life. The study aims to test the feasibility of a cognitive-behavioral eHealth app designed for pain self-management.

Inclusion Criteria

Identify as Black or LGBTQ+

Reside in MN, WI, or IA

I can use a smartphone or tablet daily and am willing to use the EPIO app.

Exclusion Criteria

Unable or unwilling to use the digital app for the study

Do not have daily access to a smart mobile device (smartphone or tablet)

I experience cancer-related pain or have severe psychological illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a cognitive-behavioral eHealth application for pain self-management

3 months

Baseline and 3-month assessments

Follow-up

Participants are monitored for changes in pain management and psychological outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EPIO App

Trial Overview The intervention being studied is the EPIO App, a cognitive-behavioral eHealth application aimed at helping individuals manage their chronic pain through various techniques provided digitally.

How Is the Trial Designed?

Group I: LGBTQIA+ adults with chronic pain Experimental Treatment 1 Intervention

Group II: Black adults with chronic pain Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a study involving 246 participants with chronic pain, the Manage My Pain (MMP) app was associated with lower anxiety levels and reduced pain catastrophizing, indicating its potential effectiveness in managing chronic pain alongside standard care.

Approximately 73.6% of participants agreed to use the app, and those who engaged with it reported significant improvements in mental health outcomes, suggesting that digital tools can enhance patient self-management in chronic pain treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial. Bhatia, A., Kara, J., Janmohamed, T., et al.[2021]

A new mobile application and remote monitoring support center were developed to improve the management of chronic pain patients, ensuring adherence to follow-up protocols and enhancing patient care.

The application was positively received by initial users, leading to minor adjustments based on their feedback, indicating its potential effectiveness in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of an integrated solution for patients with neurostimulator for chronic pain in times of COVID-19: A mobile application with a support center]. Cordero Tous, N., Santos Martín, L., Sánchez Corral, C., et al.[2023]

Electronic pain diaries and software programs for pain assessment can enhance the quality of data collected from patients with chronic pain, reducing biases associated with traditional paper methods.

While these innovative tools show promise in improving pain management, further clinical trials are necessary to establish their efficacy compared to standard assessment practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic pain assessment in clinical practice. Marceau, LD., Smith, LD., Jamison, RN.[2014]

The study involved 123 patients undergoing evaluation for spine surgery, showing that compliance rates were significantly higher for digital PROMs (82.9%) compared to paper PROMs (57.7%).

The SpineHealthie app demonstrated strong correlation with traditional paper methods for assessing patient outcomes, indicating it is an effective tool for monitoring patient function and quality of life after spine surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of smartphone app-based digital patient reported outcomes in full-endoscopic spine surgery. Pan, J., Yap, N., Prasse, T., et al.[2023]

The smartphone pain app was well tolerated and easily introduced among 90 chronic pain patients over a six-month trial, with no safety issues reported.

While greater use of the app correlated with improved mood and satisfaction, it did not lead to significant improvements in pain levels or activity, suggesting the need for strategies to enhance user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal trial of a smartphone pain application for chronic pain patients: Predictors of compliance and satisfaction. Jamison, RN., Mei, A., Ross, EL.[2018]

Patients with high-impact chronic pain found the Smerteinfo.dk website valuable for accessing information and reported improvements in understanding their condition (56%) and coping strategies (33%) after using it.

Despite its benefits, users expressed a need for more personalized information and better navigation tools, highlighting the importance of continuous updates and enhancements to the website based on user feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience and usability of a website containing research-based knowledge and tools for pain self-management: a mixed-method study in people with high-impact chronic pain. Laerkner, E., Bendix, L., Jäger, M., et al.[2023]

A mobile application and remote monitoring support center were developed to enhance the management of chronic pain patients, ensuring adherence to follow-up protocols and improving patient care.

Initial evaluations from users indicated that the application was useful, leading to minor adjustments for better usability, which highlights the importance of user feedback in healthcare technology development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an integrated solution for patients with neurostimulator for chronic pain in times of COVID-19: A mobile application with a support center. Cordero Tous, N., Santos Martín, L., Sánchez Corral, C., et al.[2022]

The study implemented a tiered approach to automate patient-reported outcome (PRO) data collection in chronic pain management, achieving a high completion rate of 96% among participants, compared to only 74% in standard clinical care.

The use of automated methods like web-based personal health records and interactive voice response calls proved effective, with age being the only demographic factor influencing response rates, suggesting that these technologies can enhance regular PRO administration in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research. Owen-Smith, A., Mayhew, M., Leo, MC., et al.[2022]

The electronic Persistent Pain Outcomes Collaboration (ePPOC) has expanded to support over 100 adult and pediatric services in Australia and New Zealand since its inception in 2013, enhancing care for individuals with persistent pain.

Improvements in benchmarking, quality indicators, and research collaborations have strengthened the integration of quality improvement initiatives within pain services, contributing to a more comprehensive outcomes registry for persistent pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A decade of outcomes: The evolution of an australasian outcomes collaboration for chronic pain services. Holloway, D., Allingham, S., Bryce, M., et al.[2023]

Among the 393 veterans surveyed, those who used the Pain Coach app reported significantly greater pain self-efficacy and lower pain interference after using the app, indicating its potential effectiveness in managing chronic pain.

Despite the positive outcomes, only 10.2% of veterans used the app, with the main barrier being a lack of discussion about the app by their healthcare teams, highlighting the need for better communication and endorsement from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Adoption and Preliminary Effectiveness of a Mobile App for Chronic Pain Management Among US Military Veterans: Pre-Post Mixed Methods Evaluation. Hogan, TP., Etingen, B., McMahon, N., et al.[2022]

A new system for collecting pain management data, called the Assessment of Pain Outcomes Longitudinal Electronic Data Capture, has been successfully implemented, with 951 new patient and 688 return visit forms entered by December 2011.

The data collection process has shown high completion rates (over 90%) and excellent accuracy (error rate of 1 in 11,250), indicating that creating a reliable pain outcomes database using validated measures is achievable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of pain outcomes in the clinical setting: development of the "APOLO" electronic data capture system. Hassett, AL., Wasserman, R., Goesling, J., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10492177/

Short-Term Findings From Testing EPIO, a Digital Self ... Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions ...

2. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-07963-x

Engaging with EPIO, a digital pain self-management program This study aimed to gain insight into the experiences of people with chronic pain when engaging with EPIO, an application (app)-based cognitive- ...

3. journals.lww.com journals.lww.com/painrpts/fulltext/2024/08000/living_well_with_chronic_pain__a_12_month.7.aspx

Living well with chronic pain: a 12-month randomized... The EPIO program aims to improve outreach of evidence-based pain self-management interventions. Findings demonstrate how using EPIO can lead to sustainable ...

4. withpower.com withpower.com/trial/phase-chronic-pain-6-2024-a026b

EPIO App for Chronic Pain (Flourish Trial) In a study involving 246 participants with chronic pain, the Manage My Pain (MMP) app was associated with lower anxiety levels and reduced pain catastrophizing, ...

5. jmir.org jmir.org/2023/1/e47284/

Short-Term Findings From Testing EPIO, a Digital Self ... Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11221858/

Living well with chronic pain: a 12-month randomized ... Findings from a 12-month randomized controlled trial revealed long-term positive psychological changes for patients with chronic pain receiving EPIO.