- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02475967
Study Assessing the Effectiveness of a Cardiac Web-based eLearning Platform (eEduHeart I)
eEduHeart I: a Multi-center Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-based eLearning Platform
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Patients participating in the trial will be provided with a cardiac web-based eLearning platform for one month during study period. The medical content of the packages will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists).
E-Learning packages type I: videos with information from caregivers. In these videos, medics and paramedics are interviewed to highlight the etiology, pathophysiology and treatment of coronary artery disease; the associated comorbidities and the ways to prevent recurrence.
E-Learning packages type II: videos in which patients are interviewed. Patients can help each other to adhere to their treatment plan, by sharing stories from their own experience about their illness and the rehabilitation afterwards. Short clips of maximum 2 minutes will be provided to study participants.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Genk, Belgia, 3600
- ZOL
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Hasselt, Belgia, 3500
- Jessa Ziekenhuis
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting
Exclusion Criteria:
- Patients with dementia or cognitive impairment not being able to sufficiently understand the E-Learning packages content
- (Foreign) patients unable to speak Dutch, thereby not being able to understand the content of the E-Learning packages
- Patients with advanced visual and/or auditory impairments, hindering them to adequately understand the E-earning packages
- Patients participating in another trial during the Pilot study period
- Patients refusing to provide signed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention group
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.
|
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.The content of platform will be gathered from a multidisciplinary input of both medics (e.g.
cardiologists) and paramedics (e.g.
psychologists).
Patients will also contribute to platform content.
|
|
Aktiv komparator: Control group
The control group patients receive conventional cardiac care alone.
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The control group patients receive conventional cardiac care alone.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Health-related quality of life
Tidsramme: 3 months
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Health-related quality of life, assessed by HeartQol
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3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Adherence to the E-learning packages
Tidsramme: 3 months
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Adherence to the E-learning packages as assessed by the number of logs and the cumulative log time on the E-learning platform per patient.
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3 months
|
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Effectiveness of E-learning packages
Tidsramme: 3 months
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Effectiveness of intervention in improving patients' knowledge of cardiac diseases as assessed by questionnaire scores.
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3 months
|
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User experience of eLearning platform
Tidsramme: 3 months
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Asses user experience of eLearning platform by User Experience Questionnaire (UEQ)
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3 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Ines Frederix, drs., Hasselt University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PDEN-IFRE 01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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