Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391073
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
Reach Out 2 Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Reach Out 2 Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Emergency department visits provide an opportunity to identify people with undiagnosed untreated or uncontrolled high blood pressure In Reach Out we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit Subsequently we will estimate the reduction in heart attack stroke and dementia if Reach Out were implemented across all US safety-net emergency departments
Detailed Description:
Hypertension is the most important modifiable risk factor for cardiovascular disease Black Americans have the highest prevalence of hypertension and the lowest rates of blood pressure BP control of any racial or ethnic group in the US contributing to cardiovascular disease disparities Low-income Americans are also disproportionally burdened by hypertension To achieve health equity new approaches to hypertension management leveraging safety-net healthcare systems to reach underserved populations are needed
One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed untreated or with undertreated hypertension - people who have fallen through the cracks in the healthcare system We did this in Reach Out 1 R01MD011516 a mobile health mHealth 8-arm factorial trial of hypertensive patients recruited from a safety-net ED Overall systolic BP declined by 92 mmHg 95 CI -122 to - 63 after 6 months without differences across treatment arms Reach Out 1 successfully enrolled a hypertensive medically underserved population into a mHealth intervention Despite a very large reduction in BP overall the efficacy of the Reach Out mHealth intervention is uncertain given the lack of a control group
Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open blinded-endpoint PROBE controlled trial Reach Out 2 continues our work with the same safety-net ED and Federally Qualified Health Centers In Reach Out 2 we will compare usual care to 6-months of prompted self-monitored blood pressure SMBP monitoring with tailored feedback and facilitated primary care appointment and transportation The usual care group will receive instructions to follow up with a primary care provider after ED discharge After 6 months the intervention participants will enter an extended treatment period of long-term SMBP monitoring To contextualize our findings we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction stroke and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention Because safety-net EDs are anchor institutions that care for large populations of medically underserved hypertensive people mHealth strategies initiated here have tremendous potential to reduce cardiovascular inequities To reach this potential evidence based interventions to reduce BP must be identified aim 1 long-term engagement evaluated aim 2 and their impact understood aim 3
One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed untreated or with undertreated hypertension - people who have fallen through the cracks in the healthcare system We did this in Reach Out 1 R01MD011516 a mobile health mHealth 8-arm factorial trial of hypertensive patients recruited from a safety-net ED Overall systolic BP declined by 92 mmHg 95 CI -122 to - 63 after 6 months without differences across treatment arms Reach Out 1 successfully enrolled a hypertensive medically underserved population into a mHealth intervention Despite a very large reduction in BP overall the efficacy of the Reach Out mHealth intervention is uncertain given the lack of a control group
Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open blinded-endpoint PROBE controlled trial Reach Out 2 continues our work with the same safety-net ED and Federally Qualified Health Centers In Reach Out 2 we will compare usual care to 6-months of prompted self-monitored blood pressure SMBP monitoring with tailored feedback and facilitated primary care appointment and transportation The usual care group will receive instructions to follow up with a primary care provider after ED discharge After 6 months the intervention participants will enter an extended treatment period of long-term SMBP monitoring To contextualize our findings we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction stroke and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention Because safety-net EDs are anchor institutions that care for large populations of medically underserved hypertensive people mHealth strategies initiated here have tremendous potential to reduce cardiovascular inequities To reach this potential evidence based interventions to reduce BP must be identified aim 1 long-term engagement evaluated aim 2 and their impact understood aim 3
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