- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01389804
Parents of Pediatric Solid Organ Transplant Recipients: Transition to Home and Chronic Illness Care
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60614
- Children's Memorial Hospital
-
-
Missouri
-
St. Louis, Missouri, Stati Uniti, 63110
- St. Louis Children's Hospital
-
-
Nebraska
-
Omaha, Nebraska, Stati Uniti, 68114
- Children's Hospital and Medical Center of Nebraska
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28203
- Levine Children's Hospital
-
-
Wisconsin
-
Milwaukee, Wisconsin, Stati Uniti, 53146
- Children's Hospital of Wisconsin
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
---|
Pediatric Solid Organ Transplant
Parents of pediatric solid organ transplant recipients
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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
Lasso di tempo: 2 years
|
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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Post transplant outcomes
Lasso di tempo: 2 years
|
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.
|
2 years
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Stacee Lerret, PhD(c), RN, Medical College of Wisconsin/Children's Hospital of Wisconsin
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHW10/115,GC 1127
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Trapianto
-
Abramson Cancer Center of the University of PennsylvaniaRitiratoPazienti affetti da cancro sottoposti a trapianto di cellule staminali (RCT of ACP for Transplant)