- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01804972
Efficacy of Patient Centred Information for Vascular Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Limerick, Irlande, 000
- Midwestern Regional Hospital
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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:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Verbal and written infomation
Verbal and written information:Patients will receive both verbal information and written patient information leaflets
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Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets
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Expérimental: Verbal and electronic information
Patient will receive both verbal information and a web address to access patient information electronically
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Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall improvement in knowledge in a group of patients with vascular disease following the provision of information through verbal, written or electronically based sources.
Délai: 6 weeks
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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.
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6 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effectiveness of providing electronically based information to the vascular patient population
Délai: 6 weeks
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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
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Stewart R Walsh, HSE and University of Limerick
Publications et liens utiles
Publications générales
- 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.
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
- INFO2013
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