Cardiac FailureNCT01822912
Heart Failure Management Program Versus Usual Care
A study testing Heart Failure Disease Management Program in people with Cardiac Failure and Congestive Heart Failure, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Failure, Congestive Heart Failure
- What is being tested?
- Heart Failure Disease Management Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 713 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Heart Failure is listed as the hospital discharge primary diagnosis
- Heart Failure is listed as the hospital discharge secondary diagnosis
Who cannot join
- Any life threatening condition which predicts mortality in 6 months or less
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiac Failure, Congestive Heart Failure
- Being tested
- Heart Failure Disease Management Program, Heart Failure Usual Care
- Keywords
- Skilled Nursing Facility, Heart Failure, Transitional Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure Disease Management ProgramOther
Subjects will be assessed 3 times a week while in SNF.
Heart Failure Usual CareOther
Subjects will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Disease Management Program | Active comparator | 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 Receives: Other: Heart Failure Disease Management Program |
| Heart Failure Usual Care | Placebo comparator | SNF patients with HF will receive usual care Receives: Other: Heart Failure Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 60 day post SNF admission outcomes
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.
Measured: Up to 60 days post SNF admission
Secondary outcomes (3)
Difference in health status and self-care 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.
Measured: 60 days post SNF admission
Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)
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.
Measured: 60 days post SNF admission
Difference in Cost-effectiveness
To assess the cost-effectiveness of heart failure disease management program vs usual care for SNF patients with HF
Measured: Up to 60 days post SNF admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Rebecca Boxer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822912
- Sponsor's protocol ID
- 14-0006
- Other IDs
- R01HL113387
- Status last verified
- Aug 2019
- First submitted
- 26 Mar 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lum H, Obafemi O, Dukes J, Nowels M, Samon K, Boxer RS. Use of Medical Orders for Scope of Treatment for Heart Failure Patients During Postacute Care in Skilled Nursing Facilities. J Am Med Dir Assoc. 2017 Oct 1;18(10):885-890. doi: 10.1016/j.jamda.2017.05.021. Epub 2017 Jul 6.
PubMed 28688730
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Skilled Nursing Facility Heart Failure Disease Management Program Versus Usual Care
- ClinicalTrials.gov ID
- NCT01822912
- Acronym / sponsor ID
- 14-0006
- Conditions
- Cardiac Failure, Congestive Heart Failure
- Keywords
- Skilled Nursing Facility, Heart Failure, Transitional Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2013
- Primary completion
- May 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Disease Management Program | Active comparator | Other: Heart Failure Disease Management ProgramPatients 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 |
| Heart Failure Usual Care | Placebo comparator | Other: Heart Failure Usual CareSNF patients with HF will receive usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Heart Failure is listed as the hospital discharge primary diagnosis
- Heart Failure is listed as the hospital discharge secondary diagnosis
Key exclusion criteria (1 listed)
- Any life threatening condition which predicts mortality in 6 months or less
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Failure Disease Management ProgramSubjects will be assessed 3 times a week while in SNF. | Other | Heart Failure Disease Management Program |
| Heart Failure Usual CareSubjects will receive standard of care. | Other | Heart Failure Usual Care |
Primary outcome
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.
3 secondary outcomes
Difference in health status and self-care 60 days post SNF admission
Time frame: 60 days post SNF admission
Change in Patients living at home 60 days post-SNF admission with Heart Failure (HF)
Time frame: 60 days post SNF admission
Difference in Cost-effectiveness
Time frame: Up to 60 days post SNF admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 28688730Lum H, Obafemi O, Dukes J, Nowels M, Samon K, Boxer RS. Use of Medical Orders for Scope of Treatment for Heart Failure Patients During Postacute Care in Skilled Nursing Facilities. J Am Med Dir Assoc. 2017 Oct 1;18(10):885-890. doi: 10.1016/j.jamda.2017.05.021. Epub 2017 Jul 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Boxer, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure Disease Management Program in people with Cardiac Failure and Congestive Heart Failure, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 60 day post SNF admission outcomes (time frame: Up to 60 days post SNF admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.