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Uncertainty Management Intervention

6. februar 2014 oppdatert av: Duke University

Uncertainty Management Intervention for Patients Awaiting Liver Transplant

The goal of this study is to improve symptoms and quality of life for end-stage liver disease patients awaiting a liver transplant and their caregivers by providing them with the resources and tools to self-manage their complex concerns.

Studieoversikt

Detaljert beskrivelse

Hepatitis C Virus is the most common blood-borne infection in the U.S., affecting at least 4 million individuals, with more than 19,000 new cases occurring each year. Further, the CDC has projected a fourfold increase in the number of chronic hepatitis C patients between 1990 and 2015, and these patients are at risk for developing end stage liver disease (ESLD). By 2015 an estimated 375,000 chronic hepatitis C patients will develop cirrhosis and progress to ESLD, representing the majority of individuals who need liver transplants. ESLD is a life-limiting illness, and patients are told that, without a liver transplant, they may die.

This 5 year randomized controlled trial will test the efficacy of an Uncertainty Management Intervention delivered via telephone by a nurse to the patient and caregiver. An attention control group of patients and caregivers will receive phone calls to discuss their experience of awaiting a liver transplant. Based on the problems and concerns of patients waiting for a liver transplant and the prior success of the Intervention for patients dealing with serious chronic illness, we believe the Uncertainty Management Intervention adapted specifically for ESLD patients will lead to significant improvements in patients' and caregivers' abilities to manage the symptoms and distress associated with ESLD and the process of awaiting liver transplant.

The specific aims are to: 1) examine the effects of the Uncertainty Management Intervention on patient outcomes of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and QOL compared to an attention control group receiving calls to discuss their disease experience; 2) explore the effects of the Intervention on caregiver outcomes of uncertainty management, self-efficacy for helping the patient manage symptoms, and better QOL compared to an attention control group; 3) identify characteristics of individuals for whom the intervention is particularly effective.

Waiting for a liver transplant under conditions of uncertainty is a harrowing experience for patients and caregivers, yet there have been few attempts to test nursing interventions for ESLD patients. The overall goal of this project is to provide these patients and their caregivers the tools to self-manage their complex concerns. The anticipated outcome is ESLD patients awaiting liver transplant benefit from the Uncertainty Management Intervention, thus providing new knowledge for practitioners and policy makers.

Studietype

Intervensjonell

Registrering (Faktiske)

288

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • The University of Nebraska Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • University of North Carolina-Chapel Hill
      • Durham, North Carolina, Forente stater, 27705
        • Duke University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15261
        • The University of Pittsburgh

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria (patient):

  • Diagnosis of ESLD and on the liver transplant waiting list
  • Receiving care at a Liver Clinic in the United States
  • 18 years of age or older
  • MELD greater than or equal to 11
  • Able to read and speak English
  • No major cognitive impairment
  • Not a recipient of a prior transplant (any organ)
  • Has a caregiver willing to participate

Inclusion Criteria (caregiver):

  • 18 years of age or older
  • Able to read and speak English
  • Provides care to a patient meeting the above criteria

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Uncertainty Management Intervention
The Uncertainty Management Intervention will consist of six 30-minute phone calls with a study educator to discuss issues of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and quality of life.
Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
Annen: Comparison Conditions for Liver Disease
Six 30-minute telephone calls that provide structured education about liver disease.
Six 30-minute telephone calls that provide structured education about liver disease.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Uncertainty Management
Tidsramme: Five months
Five months

Sekundære resultatmål

Resultatmål
Tidsramme
Symptom control
Tidsramme: Five months
Five months
Quality of life
Tidsramme: Five months
Five months
Psychological distress
Tidsramme: Five months
Five months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: James Tulsky, MD, Duke University School of Nursing
  • Hovedetterforsker: Donald Bailey, PhD, Duke University School of Nursing
  • Hovedetterforsker: Annette Devito Dabbs, PhD, RN, The University of Pittsburgh
  • Hovedetterforsker: Paul H. Hayashi, MD, MPH, University of North Carolina, Chapel Hill
  • Hovedetterforsker: Laurel Williams-Salonen, RN,MSN,CCTC, The University of Nebraska Medical Center

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. februar 2010

Primær fullføring (Faktiske)

1. september 2013

Studiet fullført (Faktiske)

1. september 2013

Datoer for studieregistrering

Først innsendt

10. juli 2009

Først innsendt som oppfylte QC-kriteriene

10. juli 2009

Først lagt ut (Anslag)

14. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. februar 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. februar 2014

Sist bekreftet

1. februar 2014

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00007468
  • 1P01NR010948-01 (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. .

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