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Heart Failure Management Program Versus Usual Care

Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01822912
Enrollment
713
Registered
2013-04-04
Start date
2013-01-31
Completion date
2019-03-31
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Failure, Congestive Heart Failure

Keywords

Skilled Nursing Facility, Heart Failure, Transitional Care

Brief summary

Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home. HF disease management programs have been shown to reduce rehospitalizations in community settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF). This study will investigate the the effect of a heart failure-disease management program on the outcome of all-cause hospital readmissions, emergency room admissions and mortality for 30 days post-SNF admission using 7 component heart failure disease management program.

Interventions

OTHERHeart Failure Disease Management Program

Subjects will be assessed 3 times a week while in SNF.

OTHERHeart Failure Usual Care

Subjects will receive standard of care.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Heart Failure is listed as the hospital discharge primary diagnosis * Heart Failure is listed as the hospital discharge secondary diagnosis

Exclusion criteria

* Any life threatening condition which predicts mortality in 6 months or less

Design outcomes

Primary

MeasureTime frameDescription
Change in 60 day post SNF admission outcomesUp to 60 days post SNF admissionTo determine the difference in the composite endpoint of 60-day all-cause hospitalization, all-cause emergency department visits and all-cause mortality between HF patients in Skilled Nursing Facilities cared for by a heart failure-disease management program vs usual care.

Secondary

MeasureTime frameDescription
Difference in health status and self-care 60 days post SNF admission60 days post SNF admissionTo compare the difference in health status and self-care for patients with HF cared for by a SNF heart failure-disease management program vs usual care 60 days post SNF admission. Health Status will be measured by the KCCQ (Kansas City Cardiomyopathy Questionnaire) which is a 23 item questionnaire specific for patients with HF. It includes aspects of physical function, symptoms (frequency, severity and stability), social function, self-efficacy, knowledge, and quality of life. HF Self Management will be measured using the SCHFI (Self-Care HF Index) which consists of 15 item scale with 3 domains of self care including self care maintenance (behaviors to maintain clinical stability), self-care management (decision making process with regard to symptom changes), and confidence to manage symptoms.
Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)60 days post SNF admissionTo determine if a SNF HF disease management program vs. usual care results in a greater proportion of HF patients who were previously living at home return home vs. admission to long term care post SNF discharge.
Difference in Cost-effectivenessUp to 60 days post SNF admissionTo assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026