NCT00415545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

5 years

First QC Date

December 21, 2006

Last Update Submit

June 6, 2013

Conditions

Heart Failure, Congestive

Keywords

Heart FailurePatient Education

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for heart failure and cardiac mortality

    Measured at Year 2

Secondary Outcomes (4)

  • Heart failure-related emergency department visits (without hospitalization)

    Measured at Year 2

  • Unplanned physician visits

    Measured at Year 2

  • Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)

    Measured at Year 2

  • Quality of life

    Measured at Year 2

Study Arms (3)

1

EXPERIMENTAL

Fluid Watchers LITE program

Behavioral: Fluid Watchers LITE Educational Intervention

2

EXPERIMENTAL

Fluid Watchers PLUS program

Behavioral: Fluid Watchers PLUS Educational Intervention

3

NO INTERVENTION

Usual care control group

Interventions

Fluid Watchers LITE Educational InterventionBEHAVIORAL

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.

1
Fluid Watchers PLUS Educational InterventionBEHAVIORAL

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Davis

Davis, California, 95817, United States

Location

University of Kentucky

Lexington, Kentucky, 40526, United States

Location

Washoe Health Care System

Reno, Nevada, 89523, United States

Location

Related Publications (8)

  • 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.

    PMID: 16290977BACKGROUND

  • 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.

    PMID: 30663898DERIVED

  • 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.

    PMID: 30353706DERIVED

  • 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.

    PMID: 29158435DERIVED

  • 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.

    PMID: 26721913DERIVED

  • 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.

    PMID: 26230482DERIVED

  • 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.

    PMID: 25146960DERIVED

  • 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.

    PMID: 24815499DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kathleen A. Dracup, DNSc

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

January 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations

US(3)