Heart FailureBEAT-HFNCT01360203
Better Effectiveness After Transition - Heart Failure
A study testing Structured Telephone / Remote Outpatient Monitoring in people with Heart Failure, run by University of California, Los Angeles at 6 sites in United States.
Trial summary
The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Structured Telephone / Remote Outpatient Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,437 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2011to Mar 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients hospitalized at any of the six medical centers who are being actively treated for heart failure.
Who cannot join
- patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
- patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
- patients with dementia,
- patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
- patients who do not have a working land line phone or reliable cell service,
- patients on chronic dialysis,
Show all 10Show fewer
- patients who cannot identify a usual source of care (free clinic is acceptable) and who will not be assigned a provider upon discharge,
- patients with the following cardiovascular conditions: patients with valvular disorders requiring surgical intervention (except for those with incidental valvular disease, who will be included), acute myocardial infarction (except for those with demand ischemia, who will be included), percutaneous coronary intervention
- patients expected to enroll in hospice or expire after discharge,
- patients who are unable to use the intervention equipment (e.g., unable to stand on the weight scale), or who are otherwise unable to comply with the intervention
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of California, Davis
Davis, California, 95616
University of California, Irvine
Irvine, California, 92697
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California, Los Angeles
Los Angeles, California, 90095
University of California, San Diego
San Diego, California, 92093
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Variations in Care: Comparing Heart Failure Care Transition Intervention Effects
The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.
- Conditions
- Heart Failure
- Being tested
- Structured Telephone / Remote Outpatient Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Telephone / Remote Outpatient MonitoringOther
Also called Care Transition Intervention, Care Transitions Intervention, Structured Telephone Monitoring, Remote Monitoring
During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.
| Study group | Role | What they receive |
|---|---|---|
| Current Care | No intervention | Patients will receive the current care provided to heart failure patients at each of the study sites |
| Care Transition Intervention | Experimental | Care transition intervention beginning prior to discharge and through six months post-discharge. Receives: Other: Structured Telephone / Remote Outpatient Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
180 day rehospitalization rate
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
Measured: at 180 days post-discharge
Secondary outcomes (6)
7 day mortality rate
Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.
Measured: within 7 days post-discharge
Change in quality of Life
Quality of life scores will be measured using standardized questionnaires, and data captured during enrollment will be compared with data captured during three post-discharge phone calls
Measured: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
30 day mortality rate
Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.
Measured: at 30 days post-discharge
180 day mortality rate
Mortality during the study period. Next of kin will be contacted in the event the patient has expired to verify death and date of death.
Measured: at 180 days post-discharge
30 day rehospitalization rate
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
Measured: at 30 days post-discharge
7 day rehospitalization rate
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
Measured: within 7 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,437 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, University of California, Davis, University of California, Irvine, University of California, San Diego, University of California, San Francisco
- Responsible party
- Principal investigator, Michael Ong, University of California, Los Angeles
- Investigators
- Michael K Ong, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360203
- Sponsor's protocol ID
- R01HS019311
- Acronym
- BEAT-HF
- Status last verified
- May 2014
- First submitted
- 18 May 2011
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.
PubMed 24725308Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.
PubMed 26857383
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations in Care: Comparing Heart Failure Care Transition Intervention Effects
- ClinicalTrials.gov ID
- NCT01360203
- Acronym / sponsor ID
- BEAT-HF / R01HS019311
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,437 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, University of California, Davis, University of California, Irvine, University of California, San Diego, University of California, San Francisco
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 May 2011 (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.
The purpose of this study is to compare the effect of implementing wireless remote monitoring combined with structured telephone monitoring, versus current care, on variation in rehospitalization among older patients hospitalized with heart failure at six medical centers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Care | No intervention | –Patients will receive the current care provided to heart failure patients at each of the study sites |
| Care Transition Intervention | Experimental | Other: Structured Telephone / Remote Outpatient MonitoringCare transition intervention beginning prior to discharge and through six months post-discharge. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients hospitalized at any of the six medical centers who are being actively treated for heart failure.
Key exclusion criteria (10 listed)
- patients who have previously received a transplant, are being evaluated for a transplant, or who are on the wait list for a transplant,
- patients who are enrolled or enrolling in hospice, or are expected to expire shortly after discharge,
- patients with dementia,
- patients who are admitted from a skilled nursing facility (SNF), or who we anticipate will be discharged to a long term stay in a SNF,
- patients who do not have a working land line phone or reliable cell service,
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 |
|---|---|---|
| Structured Telephone / Remote Outpatient MonitoringAlso: Care Transition Intervention, Care Transitions Intervention, Structured Telephone Monitoring, Remote MonitoringDuring their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device. | Other | Care Transition Intervention |
Primary outcome
180 day rehospitalization rate
Time frame: at 180 days post-discharge
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
6 secondary outcomes
7 day mortality rate
Time frame: within 7 days post-discharge
Change in quality of Life
Time frame: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
30 day mortality rate
Time frame: at 30 days post-discharge
180 day mortality rate
Time frame: at 180 days post-discharge
30 day rehospitalization rate
Time frame: at 30 days post-discharge
7 day rehospitalization rate
Time frame: within 7 days post-discharge
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 11 May 2016.
- Background: PubMed 24725308Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.
- Derived from this study: PubMed 26857383Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.
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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.
Michael K Ong, MD, PhD principal investigator
University of California, Los Angeles
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Telephone / Remote Outpatient Monitoring in people with Heart Failure, run by University of California, Los Angeles at 6 sites 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 1 inclusion and 10 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
180 day rehospitalization rate (time frame: at 180 days post-discharge). 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 NCT01360203, which also lists 2 linked publications.
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 11 May 2016.