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Validation and Implementation of Online Information Portal for Congenital Aortic and Pulmonary Valve Disease.


- candidate number27335
- NTR NumberNTR6805
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-mei-2017
- Secondary IDsMEC-2015-584 THCHOZ 2015-17
- Public TitleValidation and Implementation of Online Information Portal for Congenital Aortic and Pulmonary Valve Disease.
- Scientific TitleValidation and Implementation of Online Information Portal for Congenital Aortic and Pulmonary Valve Disease.
- ACRONYM
- hypothesisThe aim of present study is to assess the effect of a patient information portal on patient information and shared decision-making in a multicenter stepped-wedge cluster randomized trial.
- Healt Condition(s) or Problem(s) studiedCongenital heart defects
- Inclusion criteriaAll patients aged between 18 and 40 years and parents/caregivers of patients <18 years of age that are diagnosed with congenital aortic or pulmonary valve disease will be prospectively included.
- Exclusion criteriaMentally incompetent and/or legally incapable subjects will be excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-sep-2015
- planned closingdate31-dec-2017
- Target number of participants250
- InterventionsOnline information portal for (the parents of) patients
- Primary outcome HADS
- Secondary outcome SF-36 Mental Component
API
Control Preferences Scale
Decisional Conflict Scale
Patient knowledge
How well informed the patients felt
- TimepointsSurvey's are sent 1 month after outpatient clinic visit
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jonathan R.G. Etnel
- CONTACT for SCIENTIFIC QUERIES Jonathan R.G. Etnel
- Sponsor/Initiator Hartstichting
- Funding
(Source(s) of Monetary or Material Support)
Hartstichting
- Publications
- Brief summaryAll patients aged between 18 and 40 years and parents/caregivers of patients aged <18 years with congenital aortic and/or pulmonary valve disease (including tetralogy of Fallot) of ≥moderate hemodynamic severity will be prospectively included.
Participants will be enrolled from the following four Dutch centers for pediatric and congenital cardiology and heart surgery:

Erasmus Medical Center (EMC)
Radboud University Medical Center (Radboudumc)
Leiden University Medical Center (LUMC)
Amsterdam Medical Center (AMC)

The participants will be prospectively included in a stepped-wedge cluster randomized trial. In short, each center will start by including participants who do not have access to the information portal (control group). At a certain point in time, the information portal will be implemented in each center, after which participants will be enrolled that do have access to the information portal (intervention group). Each participant (in both control and intervention groups) will complete a questionnaire on patient knowledge, involvement, anxiety, depression and mental quality of life approximately four weeks after their visit to the outpatient clinic. By comparing the questionnaire results of the control group with those of the intervention group, the effect of the information portal on these outcomes will be measured.
- Main changes (audit trail)
- RECORD30-mei-2017 - 25-nov-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl