Pain, ChronicGEMININCT04340739
Group intEgrative MINdfulness Over the Internet Using an Online Platform
An observational study of Pain, Chronic, run by University of Massachusetts, Worcester at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- online patient education teach mindfulness based stress reduction
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: GEMINI: Virtual Integrative Medicine Group Visits (IMGV) for Managing Chronic Pain
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.
Read the detailed description
The objectives are:
- 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.
- 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).
- 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.
- 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).
- 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).
- To end the project with a tested, active prototype of the GEMINI chronic pain management/education/telehealth tool.
- Conditions
- Pain, Chronic
- Being tested
- online patient education teach mindfulness based stress reduction
- Keywords
- Widespread Chronic Pain, Pain, Chronic
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online patient education teach mindfulness based stress reductionOther
This is an online self management chronic pain curriculum that presents adapted Mindfulness Based Stress Reduction through videos, audios, and written materials
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: online patient education teach mindfulness based stress reduction | |
| 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. Receives: Other: online patient education teach mindfulness based stress reduction | |
| 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. Receives: Other: online patient education teach mindfulness based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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."
Measured: 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.
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start30 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), BrightOutcome
- Responsible party
- Principal investigator, Paula Gardiner, University of Massachusetts, Worcester
- Investigators
- Paula Gardiner, MD MPH, Principal investigator, University of Massachusetts, WorcesterNiina Haas, MA, Study director, BrightOutcome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340739
- Sponsor's protocol ID
- H00017069
- Other IDs
- 1R43AT010460-01
- Acronym
- GEMINI
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is not a clinical trial and the only data being collected is quantitative and qualitative feedback on our team's prototype chronic pain patient education and disease management platform, we do not plan to share any data at this time.
Publications
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.
PubMed 25105072
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEMINI: Virtual Integrative Medicine Group Visits (IMGV) for Managing Chronic Pain
- ClinicalTrials.gov ID
- NCT04340739
- Acronym / sponsor ID
- GEMINI / H00017069
- Conditions
- Pain, Chronic
- Keywords
- Widespread Chronic Pain, Pain, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), BrightOutcome
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
- 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.
- 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).
- 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).
- To end the project with a tested, active prototype of the GEMINI chronic pain management/education/telehealth tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (8 Patients) | – | Other: online patient education teach mindfulness based stress reductionA 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. |
| Cohort 2 (16 Patients) | – | Other: online patient education teach mindfulness based stress reductionA 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. |
| Cohort A (8 Healthcare Providers) | – | Other: online patient education teach mindfulness based stress reductionEight 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online patient education teach mindfulness based stress reductionThis is an online self management chronic pain curriculum that presents adapted Mindfulness Based Stress Reduction through videos, audios, and written materials | Other | Cohort 1 (8 Patients), Cohort 2 (16 Patients), Cohort A (8 Healthcare Providers) |
Primary outcome
Qualitative Feedback (Cohort 1)
Time frame: 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.
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.
Qualitative Feedback (Cohort 2)
Time frame: 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.
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.
Qualitative Feedback (Cohort A)
Time frame: 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.
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.
System Usability Scale (SUS)
Time frame: 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.
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.
Perceived Feature Usefulness Scale (PFU)
Time frame: 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.
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."
Technology Acceptance Based Model Survey
Time frame: 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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 25105072Gardiner 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.
- Individual participant dataSharing planned: No. As this is not a clinical trial and the only data being collected is quantitative and qualitative feedback on our team's prototype chronic pain patient education and disease management platform, we do not plan to share any data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Gardiner, MD MPH principal investigator
University of Massachusetts, Worcester
Niina Haas, MA study director
BrightOutcome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Feedback (Cohort 1) (time frame: 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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.