Group intEgrative MINdfulness Over the Internet Using an Online Platform

Pain, Chronic Clinical Trial

— GEMINI  

Official title:

GEMINI: Virtual Integrative Medicine Group Visits (IMGV) for Managing Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340739
• Other study ID #: H00017069
• Secondary ID: 1R43AT010460-01
• Status: Completed
• Start date: January 30, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Other:
• online patient education teach mindfulness based stress reduction
This is an online self management chronic pain curriculum that presents adapted Mindfulness Based Stress Reduction through videos, audios, and written materials

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	BrightOutcome, Inc., National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Feedback (Cohort 1)	Prototype feedback collected during a 30 min to 1 hour semi-structured interview that will be held either in person or virtually, as able and with following all external guidelines.	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.
Primary	Qualitative Feedback (Cohort 2)	Prototype feedback collected during a 30 min to 1 hour semi-structured interview that will be held either in person or virtually, as able and with following all external guidelines.	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.
Primary	Qualitative Feedback (Cohort A)	Prototype feedback collected during a 30 min to 1 hour semi-structured interview that will be held either in person or virtually, as able and with following all external guidelines.	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.
Primary	System Usability Scale (SUS)	Prototype feedback data collected from all 3 cohorts using the System Usability Scale (SUS). The System Usability Scale is a 10 item survey, with each item ranked on a Likert scale ranging from 1-5, with a calculated score ranging from 0-100 (Subtracting 1 from each odd-numbered item's answer value and for each even-numbered question, subtracting their value from 5, summing both question sets, then multiplying the sum by 2.5). Average scores must fall at or above 70 to equate acceptable usability. Further information regarding scoring can be found by reading Bangor A, Kortum P, Miller J. Determining what individual SUS scores mean: adding an adjective rating scale. J Usability Studies. 2009;4(3):114-123.	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.
Primary	Perceived Feature Usefulness Scale (PFU)	Prototype feedback data collected from Cohorts 2 and A using the Perceived Feature Usefulness Scale, a to-be designed 5-point Likert scale (from strongly disagree to strongly agree) survey. PFU cannot be fully designed before the system functions and the site structure are finalized because it would specifically ask the subject to rate the usefulness of each major system feature to guide our future product development plans. For instance, the statements could be "It is useful to view the profiles of my fellow patients in the group" or "It is useful to receive reminder emails about upcoming group sessions."	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.
Primary	Technology Acceptance Based Model Survey	Prototype feedback data collected from Cohorts 2 and A using the Technology Acceptance Based Model Survey, a 5-point Likert scale survey. This survey will be based on the Technology Acceptance Model (TAM) that has been studied extensively to predict the actual use of health information technology (HIT) systems (Holden RJ, Karsh BT. The technology acceptance model: its past and its future in health care. J Biomed Inform. 2010;43(1):159-172). Key constructs include perceived usefulness (e.g., helpful in managing pain), perceived ease of use (e.g., easy to learn, session not too long), social influence (e.g., group effects), and perceived behavioral control (e.g., feasibility of videoconferencing).	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.