- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01389804
Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Parents of children that have received a heart, kidney, liver or lung transplant will be invited to participate in this protocol.
Involvement in this study entails completion of questionnaires at 4 separate time points. Parents will first complete questionnaires regarding discharge teaching, care coordination and readiness for hospital discharge on the day of discharge from the hospital. Parents will subsequently complete questionnaires at 3 weeks, 3 months and 6 months after discharge. The post discharge questionnaires assess coping, family management, adherence and utilization of healthcare resources.
Currently, no research has been conducted related to readiness for hospital discharge of a parent as the primary caregiver for a child with solid organ transplant or the sequential relationships between hospitalization care and the trajectory of post-discharge outcomes. This research will fill the gap in knowledge needed for care of solid organ transplant children and parents.
The ability to identify factors in the first year after transplant that are predictive of decreased coping and non-adherence affords an opportunity to develop nursing and health interventions that have significant implications for care decisions, as well as disease activity and health care costs.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60614
- Children's Memorial Hospital
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Missouri
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St. Louis, Missouri, États-Unis, 63110
- St. Louis Children's Hospital
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Nebraska
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Omaha, Nebraska, États-Unis, 68114
- Children's Hospital and Medical Center of Nebraska
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North Carolina
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Charlotte, North Carolina, États-Unis, 28203
- Levine Children's Hospital
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53146
- Children's Hospital of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- the parent's child has undergone a heart, kidney, liver, lung or multivisceral transplant and is being discharged home from the hospital
- the parent is English speaking (tools being used have been validated for English participants only)
- the parent is 18 years of age or older
Exclusion Criteria:
- presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
- the child has already experienced the discharge to home transition after a previous transplant.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Pediatric Solid Organ Transplant
Parents of pediatric solid organ transplant recipients
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Determine if discharge preparation has an effect on parent readiness for hospital discharge and if readiness for hospital discharge effects post-discharge outcomes following hospital discharge in parents of solid organ transplant recipients
Délai: 2 years
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Determine if discharge preparation (discharge teaching and care coordination) for parents of solid organ transplant children has an effect on: (1) short term discharge transition outcomes and transition to home-based care (measured at 3 weeks post-discharge) and,(2) longer term chronic care outcomes at 3 and 6 months post-discharge. |
2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Post transplant outcomes
Délai: 2 years
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Determine outcomes (parent coping, adherence, family management, and utilization of healthcare services) and the relationship between these outcomes, throughout the transition to chronic care management for families of solid organ transplant recipients at 3 weeks, 3 months and 6 months post-discharge.
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2 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Stacee Lerret, PhD(c), RN, Medical College of Wisconsin/Children's Hospital of Wisconsin
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
- CHW10/115,GC 1127
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Essais cliniques sur Transplantation
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Abramson Cancer Center of the University of PennsylvaniaRetiréPatients cancéreux subissant une greffe de cellules souches (RCT of ACP for Transplant)