Group intEgrative MINdfulness Over the Internet Using an Online Platform
NCT ID: NCT04340739
Last Updated: 2022-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
35 participants
OBSERVATIONAL
2021-01-30
2021-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 (8 Patients)
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.
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
Cohort 2 (16 Patients)
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.
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
Cohort A (8 Healthcare Providers)
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
BrightOutcome
INDUSTRY
University of Massachusetts, Worcester
OTHER
Responsible Party
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Paula Gardiner
Associate Professor, Associate Research Director, Medical Group Visit Program Director
Principal Investigators
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Paula Gardiner, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Niina Haas, MA
Role: STUDY_DIRECTOR
BrightOutcome
Locations
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University of Massachusetts Medical School
Worcester, Massachusetts, United States
Countries
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References
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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.
Other Identifiers
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H00017069
Identifier Type: -
Identifier Source: org_study_id
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