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Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas (REMOTE-HF)

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluid Watchers LITE Educational Intervention
Fluid Watchers PLUS Educational Intervention
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure, Congestive focused on measuring Heart Failure, Patient Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized for heart failure in the 6 months prior to study entry
  • Able to read and write English
  • Lives independently

Exclusion Criteria:

  • Current participation in a heart failure management program
  • Impaired cognition
  • Serious co-morbidity

Sites / Locations

  • University of California, Davis
  • University of Kentucky
  • Washoe Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Fluid Watchers LITE program

Fluid Watchers PLUS program

Usual care control group

Outcomes

Primary Outcome Measures

Hospitalization for heart failure and cardiac mortality

Secondary Outcome Measures

Heart failure-related emergency department visits (without hospitalization)
Unplanned physician visits
Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)
Quality of life

Full Information

First Posted
December 21, 2006
Last Updated
June 6, 2013
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00415545
Brief Title
Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas
Acronym
REMOTE-HF
Official Title
Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Heart Failure, Patient Education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fluid Watchers LITE program
Arm Title
2
Arm Type
Experimental
Arm Description
Fluid Watchers PLUS program
Arm Title
3
Arm Type
No Intervention
Arm Description
Usual care control group
Intervention Type
Behavioral
Intervention Name(s)
Fluid Watchers LITE Educational Intervention
Intervention Description
Patients in Fluid Watchers LITE will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written material, a diary, a scale and a telephone follow-up to answer any questions they might have about the educational session.
Intervention Type
Behavioral
Intervention Name(s)
Fluid Watchers PLUS Educational Intervention
Intervention Description
Patients in Fluid Watchers PLUS will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written materials, a diary, a scale, an audio tape of the session and telephone followup. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis, as compared to participants in the LITE program.
Primary Outcome Measure Information:
Title
Hospitalization for heart failure and cardiac mortality
Time Frame
Measured at Year 2
Secondary Outcome Measure Information:
Title
Heart failure-related emergency department visits (without hospitalization)
Time Frame
Measured at Year 2
Title
Unplanned physician visits
Time Frame
Measured at Year 2
Title
Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)
Time Frame
Measured at Year 2
Title
Quality of life
Time Frame
Measured at Year 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized for heart failure in the 6 months prior to study entry Able to read and write English Lives independently Exclusion Criteria: Current participation in a heart failure management program Impaired cognition Serious co-morbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen A. Dracup, DNSc
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40526
Country
United States
Facility Name
Washoe Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89523
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16290977
Citation
Caldwell MA, Peters KJ, Dracup KA. A simplified education program improves knowledge, self-care behavior, and disease severity in heart failure patients in rural settings. Am Heart J. 2005 Nov;150(5):983. doi: 10.1016/j.ahj.2005.08.005.
Results Reference
background
PubMed Identifier
30663898
Citation
Park LG, Dracup K, Whooley MA, McCulloch C, Lai S, Howie-Esquivel J. Sedentary lifestyle associated with mortality in rural patients with heart failure. Eur J Cardiovasc Nurs. 2019 Apr;18(4):318-324. doi: 10.1177/1474515118822967. Epub 2019 Jan 21.
Results Reference
derived
PubMed Identifier
30353706
Citation
Howie-Esquivel J, Dracup K, Whooley MA, McCulloch C, Jin C, Moser DK, Clark RA, Pelter MM, Biddle M, Park LG. Rapid 5 lb weight gain is not associated with readmission in patients with heart failure. ESC Heart Fail. 2019 Feb;6(1):131-137. doi: 10.1002/ehf2.12370. Epub 2018 Oct 24.
Results Reference
derived
PubMed Identifier
29158435
Citation
Park LG, Dracup K, Whooley MA, McCulloch C, Jin C, Moser DK, Clark RA, Pelter MM, Biddle M, Howie Esquivel J. Symptom Diary Use and Improved Survival for Patients With Heart Failure. Circ Heart Fail. 2017 Nov;10(11):e003874. doi: 10.1161/CIRCHEARTFAILURE.117.003874. Erratum In: Circ Heart Fail. 2017 Dec;10(12):
Results Reference
derived
PubMed Identifier
26721913
Citation
Wu JR, Moser DK, DeWalt DA, Rayens MK, Dracup K. Health Literacy Mediates the Relationship Between Age and Health Outcomes in Patients With Heart Failure. Circ Heart Fail. 2016 Jan;9(1):e002250. doi: 10.1161/CIRCHEARTFAILURE.115.002250.
Results Reference
derived
PubMed Identifier
26230482
Citation
Hwang B, Moser DK, Pelter MM, Nesbitt TS, Dracup K. Changes in Depressive Symptoms and Mortality in Patients With Heart Failure: Effects of Cognitive-Affective and Somatic Symptoms. Psychosom Med. 2015 Sep;77(7):798-807. doi: 10.1097/PSY.0000000000000221.
Results Reference
derived
PubMed Identifier
25146960
Citation
Nesbitt T, Doctorvaladan S, Southard JA, Singh S, Fekete A, Marie K, Moser DK, Pelter MM, Robinson S, Wilson MD, Cooper L, Dracup K. Correlates of quality of life in rural patients with heart failure. Circ Heart Fail. 2014 Nov;7(6):882-7. doi: 10.1161/CIRCHEARTFAILURE.113.000577. Epub 2014 Aug 21.
Results Reference
derived
PubMed Identifier
24815499
Citation
Dracup K, Moser DK, Pelter MM, Nesbitt TS, Southard J, Paul SM, Robinson S, Cooper LS. Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas. Circulation. 2014 Jul 15;130(3):256-64. doi: 10.1161/CIRCULATIONAHA.113.003542. Epub 2014 May 9.
Results Reference
derived

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Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas

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