Group intEgrative MINdfulness Over the Internet Using an Online Platform (GEMINI)

University of Massachusetts, Worcester

Status: Completed

Conditions: Pain, Chronic

Treatments: Other: online patient education teach mindfulness based stress reduction

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04340739

H00017069

1R43AT010460-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a one-year study designed to improve upon the latest version of an education website for adult chronic pain patients called Our Whole Lives for Chronic Pain (OWL-CP). We will gain feedback from stakeholders, beta test new versions, and add the ability to conduct live Medical Group Visits through and on the virtual platform we are creating, GEMINI.

Full description

The objectives are:

1. To create a wireframe version of the Group Integrative Mindfulness over the Internet (GEMINI) website, based on feedback from previous projects, for further beta testing.
2. To engage 8 patients with chronic pain in a focus group or individual meeting (utilizing the video-conferencing tool, Zoom) to obtain feedback on the wireframe version of GEMINI through a usability test and qualitative, semi-structured interview (Cohort 1).
3. To create a prototype of the GEMINI system, using all previously collected feedback data (mentioned above), for further beta testing with both patients and providers.
4. To engage 16 patients with chronic pain in focus group(s) to collect feedback on the patient portal side of the tool, through holding a non-intervention, GEMINI telehealth session using the prototype website. No personal health information (PHI) or medical record data will be collected or recorded during this faux session (Cohort 2).
5. To engage 8 health care providers in evaluating the provider portal through asking them to conduct a GEMINI telehealth session with study staff role-playing as chronic pain patients (Cohort A).
6. To end the project with a tested, active prototype of the GEMINI chronic pain management/education/telehealth tool.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older (Patients and Healthcare Providers (HCP))
• self-reported chronic physical pain for at least 12 weeks (Patients)
• average pain intensity for the previous week >4 on a 0 to 10 numerical rating scale (Patients)
• English fluency enough to follow instructions and answer survey questions (Patients and HCPs)
• Providers who treat patients for pain will be eligible for inclusion (HCPs)

Exclusion criteria

• Subjects who are not willing or unable to participate in a focus group or individual appointment over a video conferencing platform/on the University of Massachusetts (UMass) Worcester campus and watch a computer screen and give feedback (Patients

  • HCP)

• Fetuses, prisoners, and other vulnerable populations are not eligible (Patients & HCP)

• Providers/medical students or residents directly supervised by or reporting to the Primary Investigator (HCP)

Trial design

35 participants in 3 patient groups

Cohort 1 (8 Patients)

Description:

A wireframe mock-up of the GEMINI platform will be usability tested by 8 chronic pain patients from whom feedback will be collected by completing a virtual semi-structured interview. Outcomes: Quantitative Testing Data from Usability Testing Prompt. Qualitative data collected as feedback from semi-structured interview using the Usability Test Moderator Guide.

Treatment:

Other: online patient education teach mindfulness based stress reduction

Cohort 2 (16 Patients)

Description:

A live version of GEMINI will be beta-tested by 16 chronic pain patients through completing a faux medical group visit (MGV). This will include things like exploring the education topics available, interacting with the other participating patients, and interacting with a medical provider posing as the faux group's health care provider, all in order to robustly test the system in a "live" environment. Outcomes: Quantitative Testing/User Experience Data from Usability Testing Prompt, System Usability Scale, Perceived Feature Usefulness Scale, and the Technology Acceptance Model Based Survey. Qualitative data collected as feedback from semi-structured interview using the Usability Test Moderator Guide.

Treatment:

Other: online patient education teach mindfulness based stress reduction

Cohort A (8 Healthcare Providers)

Description:

Eight healthcare providers will be divided into pairs, and these pairs will each conduct a faux medical group visit (MGV) with faux patients (staff will pose as patients). They will be asked to complete the faux session as if it were actual patients of theirs, conduct pre- and post-session tasks, and provide usability feedback on the platform. Outcomes: Quantitative Testing/User Experience Data from Usability Testing Prompt, System Usability Scale, Perceived Feature Usefulness Scale, and the Technology Acceptance Model Based Survey. Qualitative data collected as feedback from semi-structured interview using the Usability Test Moderator Guide.

Treatment:

Other: online patient education teach mindfulness based stress reduction