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Heart Failure Management Program Versus Usual Care

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01822912
First Posted: April 4, 2013
Last Update Posted: October 19, 2017
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. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver
March 26, 2013
April 4, 2013
October 19, 2017
January 2013
December 2017   (Final data collection date for primary outcome measure)
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.
30 day post SNF admission outcomes [ Time Frame: Up to 60 days post SNF admission ]
To determine the difference in the composite endpoint of 30-day all-cause hospitalization, all-cause emergency department visits and all-cause mortality between heart failure patients in Skilled Nursing Facilities cared for by a heart failure-disease management program vs usual care.
Complete list of historical versions of study NCT01822912 on ClinicalTrials.gov Archive Site
  • 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
  • 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 heart failure 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.
  • 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.
  • 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
Not Provided
Not Provided
 
Heart Failure Management Program Versus Usual Care
Evaluation of a Skilled Nursing Facility Heart Failure Disease 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Cardiac Failure
  • Congestive Heart Failure
  • Other: Heart Failure Disease Management Program
    Subjects will be assessed 3 times a week while in SNF.
  • Other: Heart Failure Usual Care
    Subjects will receive standard of care.
  • 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
    Intervention: Other: Heart Failure Disease Management Program
  • Placebo Comparator: Heart Failure Usual Care
    SNF patients with HF will receive usual care
    Intervention: Other: Heart Failure Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
713
December 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01822912
14-0006
R01HL113387 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Rebecca Boxer, MD University of Colorado, Denver
University of Colorado, Denver
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP