- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01427634
Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
5. september 2013 oppdatert av: Icahn School of Medicine at Mount Sinai
Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families
The primary aim of the study is to provide "proof of concept" to demonstrate that patients with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible.
Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.
The investigators will also examine differences in utilization of healthcare services, mortality, and completion of advance directives between intervention and control patients.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A ventricular assist device is an implanted mechanical device which augments the pumping function of the heart's ventricles.
The number of patients with VADs is expected to increase in an exponential manner in the years to come as device technology improves and continues to show a survival benefit.
The investigators propose a randomized controlled trial of a proactive palliative care intervention for patients with VADs and their caregivers.
Patients randomized to palliative care will receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study.
The intervention is delivered primarily in the outpatient setting by a palliative care nurse practitioner.
Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed.
Control patients will receive usual care as provided by the VAD clinical team.
Data collection will be performed by a research assistant at Mount Sinai (blinded to randomization) who conducts baseline assessments in person, and then follow-up assessments over the phone.
The primary aim of the study is to provide "proof of concept" to demonstrate that patients and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible.
Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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New York
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New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- age >21 years
- fluent in English
- have a caregiver/family member who is willing to be enrolled and who is also fluent in English
- consistent and reliable access to a phone
Exclusion Criteria:
- non English-speaking
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Kontroll
Vanlig omsorg
|
Receive usual care as provided by the VAD clinical team.
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Aktiv komparator: Palliative Care
Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study.
Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
|
Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study.
Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Assessment - change at 1 year from baseline
Tidsramme: baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
|
baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction with care - change at 1 year from baseline
Tidsramme: at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
|
at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
|
PROMIS anxiety scale - change at 1 year from baseline
Tidsramme: at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
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at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
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PROMIS depression scale - change at 1 year from baseline
Tidsramme: at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
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at baseline (within 2 weeks of enrollment) and at 1 year after implantment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nathan E. Goldstein, MD, Icahn School of Medicine at Mount Sinai
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Veronique L]. Circulation. 2011 Oct 18;124(16):e425.
- Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Ulisney KL, Baldwin JT, Young JB. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010 Jan;29(1):1-10. doi: 10.1016/j.healun.2009.10.009. No abstract available.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2011
Primær fullføring (Faktiske)
1. juli 2012
Studiet fullført (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først innsendt
15. august 2011
Først innsendt som oppfylte QC-kriteriene
31. august 2011
Først lagt ut (Anslag)
1. september 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. september 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. september 2013
Sist bekreftet
1. september 2013
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GCO 11-0152
- P30AG028741-01A2 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .