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

Trial Summary

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 data supports the effectiveness of the EPIO App treatment for chronic pain?

Research shows that digital apps for managing chronic pain, like the Manage My Pain app, can help improve communication between patients and healthcare providers and support self-management. Additionally, a study on a similar smartphone pain app found that users who engaged more frequently with the app reported higher satisfaction, suggesting that such apps can be beneficial for chronic pain management. ^{1 2 3 4 5}

Is the EPIO App safe for use in humans?

The EPIO App was found to be well tolerated in a study with chronic pain patients, indicating it is generally safe for use. ^{2 3 6 7 8}

How is the EPIO App treatment for chronic pain different from other treatments?

The EPIO App is unique because it is a smartphone application that allows chronic pain patients to assess, monitor, and communicate their pain status to healthcare providers, promoting self-management and enhancing patient-provider communication. ^{2 3 9 10 11}

What is the purpose of this trial?

The purpose of this study is to examine the feasibility of the dissemination of a cognitive-behavioral eHealth application (app) for pain self-management with Black and LGBTQ+ adults with high-impact chronic pain lasting at least 3 months and disrupting daily functioning (Implementation aim).

Research Team

Eleshia J. Morrison, Ph.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A decade of outcomes: The evolution of an australasian outcomes collaboration for chronic pain services. [2023]

2. Canada 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Longitudinal trial of a smartphone pain application for chronic pain patients: Predictors of compliance and satisfaction. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Validation of smartphone app-based digital patient reported outcomes in full-endoscopic spine surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of pain outcomes in the clinical setting: development of the "APOLO" electronic data capture system. [2019]

7. Germany 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Electronic pain assessment in clinical practice. [2014]

9. Spain 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. [2022]

10. Canada 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. [2022]

11. Spain 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]. [2023]