An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin (SWING)
15 marzo 2010 aggiornato da: Eli Lilly and Company
Resource Utilisation and Patient Satisfaction With SWitching INsulin (SWING)
The purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch.
The additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
2459
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Purkersdorf, Austria, 3002
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Bad Homburg, Germania, D-61350
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Athens, Grecia, 11527
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Olesnica, Polonia
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Beroun, Repubblica Ceca, 26601
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Bucharest, Romania, 020045
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Bratislava, Slovacchia, 85101
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Konya, Tacchino, 42075
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Bekescsaba, Ungheria, 5600
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Budapest, Ungheria, H-1139
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Dombovar, Ungheria, 7200
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Dunaujvaros, Ungheria, 2400
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Eger, Ungheria, 3300
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Esztergom, Ungheria, 2500
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Gyula, Ungheria, 5700
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Hodmezovasarhely, Ungheria, H-6800
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Kaposvar, Ungheria, 7400
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Karcag, Ungheria, 5301
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Kecskemet, Ungheria, 6000
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Kisber, Ungheria
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Mako, Ungheria, 6900
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Mosonmagyarovar, Ungheria, 9200
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Nagykanizsa, Ungheria, 8800
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Oroshaza, Ungheria, 5901
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Papa, Ungheria, 8500
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Pecs, Ungheria, 7623
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Szekszard, Ungheria, 7100
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients with Type II Diabetes treated with a regimen which includes any rapid-acting analog insulin or any short-acting human insulin
Descrizione
Inclusion Criteria:
- are at least 18 years of age
- according to the clinical judgement of the investigator have been diagnosed with type II diabetes
- have presented within the normal course of care
- at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other
- are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
- have been fully informed and have given their written consent for the use of their data
- have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
Exclusion Criteria:
- no specific exclusion criteria exist for this study
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Rapid acting to short acting
Patients on rapid-acting analog insulins who switch to short-acting human insulin
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prescribed in accordance with usual clinical practice
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Short acting to rapid acting
Patients on short-acting human insulins who switch to rapid-acting analog insulin
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prescribed in accordance with usual clinical practice
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The estimation of the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and a short-acting human insulin therapy within the first year following the switch.
Lasso di tempo: 1 year
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1 year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change in Euro Quality of Life (EQ-5D)
Lasso di tempo: 1 year
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1 year
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Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Lasso di tempo: 1 year
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1 year
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Change in Diabetes Health Profile (DHP-18)
Lasso di tempo: 1 year
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1 year
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The estimation of the total costs (direct and indirect) associated with switching, in either direction, between rapid-acting analog and short-acting human insulin within the first year following the switch
Lasso di tempo: 1 year
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1 year
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2007
Completamento primario (Effettivo)
1 febbraio 2010
Completamento dello studio (Effettivo)
1 febbraio 2010
Date di iscrizione allo studio
Primo inviato
23 ottobre 2007
Primo inviato che soddisfa i criteri di controllo qualità
23 ottobre 2007
Primo Inserito (Stima)
26 ottobre 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
16 marzo 2010
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 marzo 2010
Ultimo verificato
1 marzo 2010
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 11760
- F3Z-EW-B003 (Altro identificatore: Eli Lilly)
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 .