Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415545
Status:
COMPLETED
Last Update Posted:
2013-06-07
First Post:
2006-12-21
Brief Title:
Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure
Status:
COMPLETED
Status Verified Date:
2013-06
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:
REMOTE-HF
Brief Summary:
Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas
Detailed Description:
Heart failure is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body It is important for individuals with heart failure to closely monitor their symptoms and seek out medical attention when appropriate Swelling and weight gain are common heart failure symptoms that indicate excess fluid buildup in the body and worsening heart function Closely monitoring and responding to these symptoms can be a strategic way to prevent heart failure exacerbations However many patients ignore symptoms and are reluctant to seek care Specialized monitoring programs can help heart failure patients to respond more appropriately to their symptoms
Traditionally heart failure patients living in rural areas have had limited access to formal monitoring programs Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms specifically excess fluid buildup The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas
In this 2-year study 710 participants will be randomly assigned to either the Fluid Watchers LITE program the Fluid Watchers PLUS program or a usual care control group Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies Participants in the PLUS program will receive additional counseling audio tapes and follow-up telephone calls on a biweekly basis All participants will record self-monitoring adherence and contact with healthcare providers Outcome measures will be assessed during either clinic or home visits at study entry and Months 3 12 and 24 and will include number of emergency department visits number of physician visits heart failure severity and quality of life
Traditionally heart failure patients living in rural areas have had limited access to formal monitoring programs Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms specifically excess fluid buildup The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas
In this 2-year study 710 participants will be randomly assigned to either the Fluid Watchers LITE program the Fluid Watchers PLUS program or a usual care control group Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies Participants in the PLUS program will receive additional counseling audio tapes and follow-up telephone calls on a biweekly basis All participants will record self-monitoring adherence and contact with healthcare providers Outcome measures will be assessed during either clinic or home visits at study entry and Months 3 12 and 24 and will include number of emergency department visits number of physician visits heart failure severity and quality of life
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL083176-01A1 | NIH | None | httpsreporternihgovquickSearchR01HL083176-01A1 |
| R01HL083176 | NIH | None | None |