Clinical trial NCT04340739: Group intEgrative MINdfulness Over the Internet Using an Online Platform
Official title: GEMINI: Virtual Integrative Medicine Group Visits (IMGV) for Managing Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Keywords: Widespread Chronic Pain
Pain, Chronic
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: BrightOutcome
First posted: 2020-04-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pain patients will be recruited from the local Central Massachusetts area, with a focus on the adult primary care clinics within the UMass Memorial System. Providers can and will be recruited nationally through listservs, professional organizations, and word of mouth.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Qualitative Feedback (Cohort 1)
timeFrame: Following 30 minute hands-on evaluation of system and brief (max 10 mins) survey collection (SUS, listed as add'l outcomes), duration of up to 1 hour. Session max of 2 hours.
measure: Qualitative Feedback (Cohort 2)
timeFrame: Following 30 minute hands-on evaluation of system and brief (max 30 mins) survey collection (SUS, PFU, TAM-B, all listed as add'l outcomes), duration of up to 1 hour. Session max of 2 hours.
measure: Qualitative Feedback (Cohort A)
timeFrame: Following 30 minute hands-on evaluation of system and brief (max 30 mins) survey collection (SUS, PFU, TAM-B, all listed as add'l outcomes), duration of up to 1 hour. Session max of 2 hours.
measure: System Usability Scale (SUS)
timeFrame: Following 30 minute hands-on evaluation of system, up to 10 minutes, followed by Qualitative Feedback collection to end session. Session max of 2 hours.
measure: Perceived Feature Usefulness Scale (PFU)
timeFrame: Following 30 minute hands-on evaluation of system, up to 10 minutes (30 mins for all 3 surveys), followed by Qualitative Feedback collection to end session. Session max of 2 hours.
measure: Technology Acceptance Based Model Survey
timeFrame: Following 30 minute hands-on evaluation of system, up to 10 minutes (30 mins for all 3 surveys), followed by Qualitative Feedback collection to end session. Session max of 2 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Paula Gardiner, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: BrightOutcome
name: Niina Haas, MA
role: STUDY_DIRECTOR
References:
citation: Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.