- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Genk, Belgien, 3600
- ZOL
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Hasselt, Belgien, 3500
- Jessa Ziekenhuis
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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:
- 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intervention group
The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Ines Frederix, drs., Hasselt University
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PDEN-IFRE 01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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