Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472544
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Trauma-Informed Intervention for Rheumatoid Arthritis on Blackfeet Nation
Sponsor:
Blackfeet Community College
Organization:
Blackfeet Community College
Study Overview
Official Title:
Trauma-informed Intervention for Rheumatoid Arthritis on Blackfeet Nation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this study is to determine whether an intervention grounded in Blackfeet culture improves systemic inflammation and symptoms of arthritis in Blackfeet People with rheumatoid arthritis The intervention is designed to increase conectedness of Blackfeet people to Blackfeet culture and community The intervention will consist of one week of meetings in which Blackfeet Elders talk about Blackfeet historical trauma culture traditions and cerimonies The second week of the intervention consists of visiting Blackfeet sacred sites guided by Blackfeet Elders Participants will complete surveys to determine their conectedness to Blackfeet Culture level of stress Adverse Childhood Experiences Score ACES and arthritis symptoms Participants will also be evaluated for clinical severity of arthritis and biomarkers of systemic inflammation Participants will be evaluated pre- and post-intervention as well as 6 months post-intervention
Detailed Description:
The prevalence rate of rheumatoid arthritis RA in Blackfeet Nation members is among the highest in North America With our current NARCH funding we have found that cultural connectiveness in members of the Blackfeet Nation ameliorated the pro-inflammatory effects associated with high exposure to adverse childhood experiences ACES This raises the question of whether improving cultural connectedness might be an effective trauma-informed approach to improve function outcome andor a sense of well-being in individuals with rheumatic diseases such as RA The plausibility of taking this approach is grounded on the high exposure rates to ACEs in individuals living on and near the Blackfeet Reservation and the strong association between ACEs and systemic inflammation Thus we will test the hypothesis that a trauma-informed intervention aimed to improve cultural connectiveness will improve subjective and objective features of RA in individuals living on or near the Blackfeet Nation Reservation This research project will serve the overall goal of the NARCH grant by 1 building on past NARCH research to better understand physical and mental health of the Blackfeet Nation 2 building capacity for health research at BCC-CCM through engagement and training of BCC students driving scholarly productivity of BCC faculty and building new inter-institutional collaborations and 3 generate compelling results to address health concerns for the Blackfeet Nation We propose 2 aims that can be accomplished over the time frame of this application
Specific Aim 1 We will test the effects of a 2-week intervention designed to connect individuals with RA more strongly to Blackfeet language cultures ceremonies and land This pilot intervention of limited size will consist of assessing the clinical symptoms of RA ACES scores and biomarkers of inflammation before and immediately after the culturally grounded intervention This pilot will inform a second more encompassing intervention in aim 2 Specific Aim 2 We will test the hypothesis that a 2-week intervention to improve cultural connectedness in individuals with RA living on or near the Blackfeet Nation result in objective changes to pro-inflammatory markers including markers associated with disease activity in RA We believe developing an intervention which could reduce systemic inflammation could not only ameliorate symptoms of RA but possibly other inflammation-mediated diseases as well
Specific Aim 1 We will test the effects of a 2-week intervention designed to connect individuals with RA more strongly to Blackfeet language cultures ceremonies and land This pilot intervention of limited size will consist of assessing the clinical symptoms of RA ACES scores and biomarkers of inflammation before and immediately after the culturally grounded intervention This pilot will inform a second more encompassing intervention in aim 2 Specific Aim 2 We will test the hypothesis that a 2-week intervention to improve cultural connectedness in individuals with RA living on or near the Blackfeet Nation result in objective changes to pro-inflammatory markers including markers associated with disease activity in RA We believe developing an intervention which could reduce systemic inflammation could not only ameliorate symptoms of RA but possibly other inflammation-mediated diseases as well
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