- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01804972
Efficacy of Patient Centred Information for Vascular Disease
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Limerick, Irland, 000
- Midwestern Regional Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Effectiveness of providing electronically based information to the vascular patient population
Tidsramme: 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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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Stewart R Walsh, HSE and University of Limerick
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INFO2013
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Kliniske forsøg med Vaskulær sygdom
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McMaster UniversityCanadian Institutes of Health Research (CIHR); Population Health Research... og andre samarbejdspartnereAktiv, ikke rekrutterendeKirurgi (hjerte) | Kirurgi (Major Vascular)Canada, Det Forenede Kongerige
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Saint Camillus International University of Health...AfsluttetTilfredshed, patient | Bradykardi | Tilfredshed, personlig | Hypotension under operation | Kvalme/opkastning | Kirurgi (Major Vascular) | Desaturation | Hypertension arteriel | Fentanyl analgesi | Dexmedetomidin inducerede sedationItalien
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University of CincinnatiNational Institute of Nursing Research (NINR)Aktiv, ikke rekrutterendeSlag | FamilieplejereForenede Stater
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Cliniques universitaires Saint-Luc- Université...UkendtKronisk lymfatisk leukæmiBelgien