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OpenTrials
Completed

NCT Number: NCT01822912

Heart Failure Management Program Versus Usual Care

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Failure Disease Management Program

Other

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

Heart Failure Usual Care

Other

Subjects will receive standard of care.

Primary outcomes

  1. Change in 60 day post SNF admission outcomes

    Time frame: Up to 60 days post SNF admission

    To 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 outcomes

  1. Difference in health status and self-care 60 days post SNF admission

    Time frame: 60 days post SNF admission

    To 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.

  2. Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)

    Time frame: 60 days post SNF admission

    To 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.

  3. Difference in Cost-effectiveness

    Time frame: Up to 60 days post SNF admission

    To assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Apr 4, 2013
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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