Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792085
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2023-01-26
Brief Title:
Heart Failure Optimization at Home to Improve Outcomes Hozho A Pragmatic in Navajo Nation
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Heart Failure Optimization at Home to Improve Outcomes Hozho A Pragmatic Clinic Trial of Telephone-Based GDMT Optimization in Navajo Nation
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Hozho
Brief Summary:
Heart failure causes significant morbidity and mortality particularly in Navajo Nation There are well-established evidence of improved mortality and lower heart failure hospitalizations with certain pharmacotherapies for heart failure with reduced ejection fraction HFrEF However these medications are underutilized nationally including in the Indian Health Service which is one important driver of poor heart failure outcomes Therefore as part of an EHR-based pragmatic clinic trial we are implementing and testing a model that identifies American Indian HFrEF patients receiving care at one large Indian Health Service Site who meet clinical criteria for but are not on appropriate therapy and implements a model in patients are initiated and titrated on appropriate therapy over the phone with remote tele monitoring using home blood pressure cuff We will evaluate the impact of this model to improve uptake of GDMT among HFrEF patients
Detailed Description:
None
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