- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01360203
Better Effectiveness After Transition - Heart Failure (BEAT-HF)
10. maj 2016 opdateret af: Michael Ong, University of California, Los Angeles
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1437
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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Davis, California, Forenede Stater, 95616
- University of California, Davis
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Irvine, California, Forenede Stater, 92697
- University of California, Irvine
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Los Angeles, California, Forenede Stater, 90095
- University of California, Los Angeles
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Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai Medical Center
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San Diego, California, Forenede Stater, 92093
- University of California, San Diego
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San Francisco, California, Forenede Stater, 94143
- University of California, San Francisco
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- patients hospitalized at any of the six medical centers who are being actively treated for heart failure.
Exclusion Criteria:
- 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,
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Current Care
Patients will receive the current care provided to heart failure patients at each of the study sites
|
|
Eksperimentel: Care Transition Intervention
Care transition intervention beginning prior to discharge and through six months post-discharge.
|
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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
180 day rehospitalization rate
Tidsramme: at 180 days post-discharge
|
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
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at 180 days post-discharge
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
7 day mortality rate
Tidsramme: within 7 days post-discharge
|
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.
|
within 7 days post-discharge
|
Change in quality of Life
Tidsramme: as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
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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
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as an inpatient, within 7 days post-discharge, and at 30 and 180 days post-discharge
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30 day mortality rate
Tidsramme: at 30 days post-discharge
|
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.
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at 30 days post-discharge
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180 day mortality rate
Tidsramme: at 180 days post-discharge
|
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.
|
at 180 days post-discharge
|
30 day rehospitalization rate
Tidsramme: at 30 days post-discharge
|
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
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at 30 days post-discharge
|
7 day rehospitalization rate
Tidsramme: within 7 days post-discharge
|
Patient self-report in response to telephone survey, combined with administrative claims data of rehospitalization for any cause
|
within 7 days post-discharge
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael K Ong, MD, PhD, University of California, Los Angeles
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- Ong 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. Erratum In: JAMA Intern Med. 2016 Apr;176(4):568. JAMA Intern Med. 2016 Jun 1;176(6):871.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2011
Primær færdiggørelse (Faktiske)
1. marts 2014
Studieafslutning (Faktiske)
1. marts 2014
Datoer for studieregistrering
Først indsendt
18. maj 2011
Først indsendt, der opfyldte QC-kriterier
23. maj 2011
Først opslået (Skøn)
25. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. maj 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. maj 2016
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01HS019311 (U.S.A. AHRQ bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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