NCT00141856

Brief Summary

The primary objective of this telephonic heart failure specific patient education study is to assess the incremental clinical, psycho-social, and functional lifestyle benefits of the Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study) when added to standard care among veteran beneficiaries with a heart failure diagnosis. A secondary objective is to assess the impact of the Health E Heart Study on total system utilization costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 23, 2008

Status Verified

June 1, 2008

Enrollment Period

3 years

First QC Date

August 30, 2005

Last Update Submit

June 19, 2008

Conditions

Heart Failure, Congestive

Keywords

Dis ManagementHeart DecompensationHeartsVeteran (M01.930)

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular death/re-hospitalization within 6 to12 months from enrollment; 6 to 12 month all-cause mortality/re-hospitalization treatment failure; 6-month heart failure mortality/re-hospitalization; interim analyses

    At 6 months and at 12 months

Secondary Outcomes (2)

  • all measures at 6-month intervals

  • Secondary outcomes include alternative definitions of clinical impact through chart review at study start; functional status and resource utilization and costs at study start, at 6 months, and at twelve months.

Study Arms (1)

1

OTHER
Behavioral: Telephone care

Interventions

Telephone careBEHAVIORAL
1

Eligibility Criteria

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

You may qualify if:

  • Be 18 years of age
  • Have a diagnosis of heart failure
  • Have received care in urgent care or have been hospitalized, or have more than 12 outpatient visits in the last twelve months.
  • Speak either English or Spanish.

You may not qualify if:

  • End-stage renal disease on chronic dialysis
  • Prior heart transplant
  • End-stage or terminal illness in addition to heart failure, such as metastatic malignancy or AIDS with anticipated life expectancy less than 6 months.
  • Residence in a nursing home
  • Currently participating in another research or care management program.
  • No access to a telephone
  • Severe dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA South Texas Health Care System

San Antonio, Texas, 78229-5700, United States

Location

Related Publications (6)

  • Goff DC Jr, Pandey DK, Chan FA, Ortiz C, Nichaman MZ. Congestive heart failure in the United States: is there more than meets the I(CD code)? The Corpus Christi Heart Project. Arch Intern Med. 2000 Jan 24;160(2):197-202. doi: 10.1001/archinte.160.2.197.

    PMID: 10647758RESULT

  • Berg GD, Wadhwa S, Johnson AE. A matched-cohort study of health services utilization and financial outcomes for a heart failure disease-management program in elderly patients. J Am Geriatr Soc. 2004 Oct;52(10):1655-61. doi: 10.1111/j.1532-5415.2004.52457.x.

    PMID: 15450041RESULT

  • Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, Freeman GL. Long-term healthcare and cost outcomes of disease management in a large, randomized, community-based population with heart failure. Circulation. 2004 Dec 7;110(23):3518-26. doi: 10.1161/01.CIR.0000148957.62328.89. Epub 2004 Nov 7.

    PMID: 15531765RESULT

  • Fonarow GC. Heart failure disease management programs: not a class effect. Circulation. 2004 Dec 7;110(23):3506-8. doi: 10.1161/01.CIR.0000151101.17629.20. No abstract available.

    PMID: 15583088RESULT

  • Mendez GF, Cowie MR. The epidemiological features of heart failure in developing countries: a review of the literature. Int J Cardiol. 2001 Sep-Oct;80(2-3):213-9. doi: 10.1016/s0167-5273(01)00497-1.

    PMID: 11578717RESULT

  • McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD; Resource Utilization Among Congestive Heart Failure (REACH) Study. Confirmation of a heart failure epidemic: findings from the Resource Utilization Among Congestive Heart Failure (REACH) study. J Am Coll Cardiol. 2002 Jan 2;39(1):60-9. doi: 10.1016/s0735-1097(01)01700-4.

    PMID: 11755288RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Richard L Bauer, MD MSc BA

    VA South Texas Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 23, 2008

Record last verified: 2008-06

Locations

US(1)