Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas
NCT ID: NCT00415545
Last Updated: 2013-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
614 participants
INTERVENTIONAL
2007-01-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1
Fluid Watchers LITE program
Fluid Watchers LITE Educational Intervention
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.
2
Fluid Watchers PLUS program
Fluid Watchers PLUS Educational Intervention
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.
3
Usual care control group
No interventions assigned to this group
Interventions
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Fluid Watchers LITE Educational Intervention
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.
Fluid Watchers PLUS Educational Intervention
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.
Eligibility Criteria
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Inclusion Criteria
* Able to read and write English
* Lives independently
Exclusion Criteria
* Impaired cognition
* Serious co-morbidity
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Institute of Nursing Research (NINR)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Kathleen A. Dracup, DNSc
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, Davis
Davis, California, United States
University of Kentucky
Lexington, Kentucky, United States
Washoe Health Care System
Reno, Nevada, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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