Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Positive Minds Strong Joints for Knee Osteoarthritis
Sponsor:
Boston University Charles River Campus
Organization:
Boston University Charles River Campus
Study Overview
Official Title:
Physical and Mental Health Intervention for Black Adults With Knee Osteoarthritis A Randomized Controlled Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PMSJ
Brief Summary:
The aim of this research study is to test the feasibility of a physical and mental health intervention Positive Minds Strong Joints or PMSJ for Black adults with knee osteoarthritis OA
Detailed Description:
In this feasibility RCT study 40 Black Adults will be enrolled to either receive PMSJ or usual care Participants who will take part in this research study will be in it for about 26 weeks Participants in the PMSJ group will receive a one-hour individual session of psycho-education mindfulness and cognitive behavior therapy skills for 10 weeks via a HIPAA-protected zoom video-call or over the telephone In addition they will receive a community-based group exercise and pain education program once a week for 10 weeks Participants in this group will also continue to receive their usual care Participants in the usual care will not receive any additional intervention from the researchers All participants will be asked to take surveys at five time points ie before the start of the 10-week intervention baseline visit mid-way through the intervention week 5 end of the 10-week intervention post-intervention 6 weeks after the intervention week 16 and 12 weeks after the intervention week 22 Brief surveys will also be completed weekly throughout the study The surveys will be about pain function quality of life mood social support sleep etc At baseline and post-intervention visits all participants will be asked to wear a small movement sensor on their lower back They will complete a remote assessment of their walking function while wearing this sensor and also wear this sensor for 7 days of continuous movement and physical activity monitoring Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate retention rate and adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None