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- Essai clinique NCT00938795
Uncertainty Management Intervention
Uncertainty Management Intervention for Patients Awaiting Liver Transplant
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Nebraska
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Omaha, Nebraska, États-Unis, 68198
- The University of Nebraska Medical Center
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina-Chapel Hill
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Durham, North Carolina, États-Unis, 27705
- Duke University
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15261
- The University of Pittsburgh
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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.
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Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
|
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Autre: Comparison Conditions for Liver Disease
Six 30-minute telephone calls that provide structured education about liver disease.
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Six 30-minute telephone calls that provide structured education about liver disease.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Uncertainty Management
Délai: Five months
|
Five months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Symptom control
Délai: Five months
|
Five months
|
|
Quality of life
Délai: Five months
|
Five months
|
|
Psychological distress
Délai: Five months
|
Five months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: James Tulsky, MD, Duke University School of Nursing
- Chercheur principal: Donald Bailey, PhD, Duke University School of Nursing
- Chercheur principal: Annette Devito Dabbs, PhD, RN, The University of Pittsburgh
- Chercheur principal: Paul H. Hayashi, MD, MPH, University of North Carolina, Chapel Hill
- Chercheur principal: Laurel Williams-Salonen, RN,MSN,CCTC, The University of Nebraska Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00007468
- 1P01NR010948-01 (Subvention/contrat des NIH des États-Unis)
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