Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634810
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SAMBA COPD
Brief Summary:
The Icahn School of Medicine at Mount Sinai will conduct a randomized controlled trial of a self-management support intervention for predominantly minoritized and low-income adults with chronic obstructive pulmonary disease COPD The trial will focus on comprehensive screening and targeted management of barriers to COPD control incorporating home-based pulmonary rehabilitation and oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations The research team will compare this intervention with an attention control group to evaluate the effects on medication adherence COPD symptoms inhaler technique physical activity and exercise capacity at 6 months and at 12 months to examine sustainability of treatment effects The research team will also examine hospitalizations and emergency department visits at 12 months The study will recruit 300 participants from the Mount Sinai Health System in Manhattan Queens and Brooklyn ensuring diverse representation Health coaches from the VNS Health will deliver the intervention guided by a detailed training manual Weekly conference calls will address logistical and protocol-related issues
Detailed Description:
The Icahn School of Medicine at Mount Sinai is the lead and only site of recruitment for this project Research study activities will be conducted at practices across the Mount Sinai Health System The research team will identify a patient pool through the electronic health record The research team will recruit 300 150 per arm participants from the Mount Sinai Health System in Manhattan Queens and Brooklyn in NYC These practices provide care to a diverse population with considerable sociodemographic diversity 40 Latino and 30 Black 50 with household incomes 1350month Randomization will occur 1 month after the baseline interview and after the devices are returned Randomization will be in blocks of variable size 4 to 6 and stratified by Global Initiative for Chronic Obstructive Lung Disease GOLD criteria B or E The studys main outcomes will be assessed at 6 months and sustainability of treatment effects at 12 months The intervention will be delivered by community health workers CHWhealth coaches employed by VNS Health The research team will follow a detailed intervention training manual and Manual of Operations to guide CHWs through the intervention The CHWs will also attend a 90-minute monthly group meeting to discuss cases and hear presentations on topics of their choosing for skills and knowledge development The research team will meet by conference call weekly to discuss logistical issues refinement of protocol and other issues pertaining to the study The project manager will email any modifications to the IRB and research coordinator within one day of receiving approval The project manager will also email a copy of the amendment approval letter Mount Sinai will abide by IRB policies as serving site
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