Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515925
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Our Whole Lives Gemini Virtual Integrative Medical Group Visits for Managing Chronic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II GEMINI Virtual Integrative Medical Group Visits for Managing Chronic Pain
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to test the efficacy of a non-prescription medicine web-based platform solution for patients with chronic pain to improve pain self-management and related outcomes The main question investigators aim to answer is would the use of this web-based intervention plus an online group visit compared to control result in better pain-related outcomes and improved pain impact
Detailed Description:
This study has 6 mandatory components and 1 optional component
Recruitment Screening Call
Informed Consent Session
Baseline Survey Session
Intervention Engagement with the Our Whole Lives OWL an e-health platform For 9 weeks participants will all have access to a mindfulness program within OWL optimized for people with chronic pain
Live-Online Mindfulness Group weekly
Control Low dose engagement with OWL with no group engagement
Follow-Up Survey Sessions at Week 10 Week 16 and Week 24
Online Focus GroupIndividual Interview Participants will be asked to participate in an OPTIONAL individual interview or a one-hour focus group with other participants in the study who used the OWL website as well
Researchers will compare two groups that will be using the web-based platform Each group will have different engagement content from the web-based platform and investigators will see if it affects overall chronic pain and pain management
Recruitment Screening Call
Informed Consent Session
Baseline Survey Session
Intervention Engagement with the Our Whole Lives OWL an e-health platform For 9 weeks participants will all have access to a mindfulness program within OWL optimized for people with chronic pain
Live-Online Mindfulness Group weekly
Control Low dose engagement with OWL with no group engagement
Follow-Up Survey Sessions at Week 10 Week 16 and Week 24
Online Focus GroupIndividual Interview Participants will be asked to participate in an OPTIONAL individual interview or a one-hour focus group with other participants in the study who used the OWL website as well
Researchers will compare two groups that will be using the web-based platform Each group will have different engagement content from the web-based platform and investigators will see if it affects overall chronic pain and pain management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None