- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01804972
Efficacy of Patient Centred Information for Vascular Disease
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Hospitals and health care institutions attempt to provide information to patients through a variety of media including; written information, web-site based information and more recently through the use of smart phone based applications. Such educational campaigns have financial implications for hospitals and institutions.
The level of knowledge among patients with vascular disease of their pathology and its associated risk factors has been shown to be poor (Lovell et al 2009, Hirsch et al 2007). The optimum tool with which to provide information to patients with vascular disease has not been determined to date.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
-
Limerick, Irlanda, 000
- Midwestern Regional Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Newly diagnosed abdominal aortic aneurysm, peripheral vascular disease or varicose veins
- Capacity to and willingness to consent to participation in the study
- Adult patients
- In-patient or out-patient status
Exclusion Criteria:
- Previously diagnosed with vascular disease
- Limited capacity or unwilling to consent
- Information already provided by hospital doctor
- Cognitive/intellectual impairment/acquired brain injury/visual impairment
- Qualified medical professionals
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Verbal and written infomation
Verbal and written information:Patients will receive both verbal information and written patient information leaflets
|
Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets
|
|
Sperimentale: Verbal and electronic information
Patient will receive both verbal information and a web address to access patient information electronically
|
Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall improvement in knowledge in a group of patients with vascular disease following the provision of information through verbal, written or electronically based sources.
Lasso di tempo: 6 weeks
|
Patients will be randomised to receive either verbal and written information or verbal and electronically based information on their disease specific condition.
Knowledge will be assessed through the use of a multi choice questionnaire at baseline prior to the provision of information on their condition and again at follow up 6 weeks later.
|
6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Effectiveness of providing electronically based information to the vascular patient population
Lasso di tempo: 6 weeks
|
At follow patients will be asked to complete a questionnaire detailing their use of the information provided. The following measures will be recorded: Did you access the website address provided Y/N If Yes, How many times did you access the website (Specify) ____________________ Did you find the website useful or informative Yes/No/Somewhat Did you read the information leaflet provided Y/N If Yes, How many times did you read the leaflet (Specify) ______________________ Did you find the leaflet useful or informative Yes/No/Somewhat |
6 weeks
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Stewart R Walsh, HSE and University of Limerick
Pubblicazioni e link utili
Pubblicazioni generali
- Lovell M, Harris K, Forbes T, Twillman G, Abramson B, Criqui MH, Schroeder P, Mohler ER 3rd, Hirsch AT; Peripheral Arterial Disease Coalition. Peripheral arterial disease: lack of awareness in Canada. Can J Cardiol. 2009 Jan;25(1):39-45. doi: 10.1016/s0828-282x(09)70021-2.
- Hirsch AT, Murphy TP, Lovell MB, Twillman G, Treat-Jacobson D, Harwood EM, Mohler ER 3rd, Creager MA, Hobson RW 2nd, Robertson RM, Howard WJ, Schroeder P, Criqui MH; Peripheral Arterial Disease Coalition. Gaps in public knowledge of peripheral arterial disease: the first national PAD public awareness survey. Circulation. 2007 Oct 30;116(18):2086-94. doi: 10.1161/CIRCULATIONAHA.107.725101. Epub 2007 Sep 17.
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
- INFO2013
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 .