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Heart Failure Management Program Versus Usual Care

This study is currently recruiting participants.
Verified November 2016 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822912
First Posted: April 4, 2013
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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.


Condition Intervention
Cardiac Failure Congestive Heart Failure Other: Heart Failure Disease Management Program Other: Heart Failure Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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


Estimated Enrollment: 1400
Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Heart Failure Disease Management Program
Patients will receive personalized care to include medication titration, daily weights, symptom and activity assessment, documentation of ejection fraction, patient and caregiver education,dietary surveillance, discharge instructions and follow up visit within 7 days of SNF discharge
Other: Heart Failure Disease Management Program
Subjects will be assessed 3 times a week while in SNF.
Placebo Comparator: Heart Failure Usual Care
SNF patients with HF will receive usual care
Other: Heart Failure Usual Care
Subjects will receive standard of care.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822912


Contacts
Contact: Melissa Smith, MBA 303.724.8466 melissa.a.smith@ucdenver.edu
Contact: Rebecca Boxer, MD 303.724.1922 rebecca.boxer@ucdenver.edu

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Rebecca Boxer, MD, MS         
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Rebecca Boxer, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01822912     History of Changes
Other Study ID Numbers: 14-0006
R01HL113387 ( U.S. NIH Grant/Contract )
First Submitted: March 26, 2013
First Posted: April 4, 2013
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by University of Colorado, Denver:
Skilled Nursing Facility
Heart Failure
Transitional Care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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