The decision aid will support couples at risk of transmitting a genetic disease to their offspring in their decision-making regarding the fulfillment of their child wish. HP1: The decision aid will lead to a statistically significant decrease of…
ID
Bron
Verkorte titel
Aandoening
Hereditary Diseases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Decisional conflict. This will be assessed by means of the Decisional Conflict Scale (O’Connor, 1995).
Achtergrond van het onderzoek
A nationwide multi-center randomized controlled trial will be implemented to investigate the immediate, short- and long term efficacy of a decision aid (DA) aimed to support couples at risk of transmitting a genetic disease in making a decision regarding reproductive options . Couples will be randomly allocated to a control group (standardized information) and an experimental group (DA).
Doel van het onderzoek
The decision aid will support couples at risk of transmitting a genetic disease to their offspring in their decision-making regarding the fulfillment of their child wish. HP1: The decision aid will lead to a statistically significant decrease of decisional conflict.
HP2: The decision aid will lead to a statistically significant increase in informed decision-making after using the decision aid
Onderzoeksopzet
Baseline (before intervention, T0), immediately after viewing the DA/standardized information intervention, (T1) after 1 month (T2) and after 6 months (T3).
Onderzoeksproduct en/of interventie
Decision aid with written and visual information, including value clarification methods (VCMs).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
One of the partners has an autosomal dominant hereditary condition, an X-linked condition, a chromosomal anomaly or both partners are carrier of an autosomal recessive condition for which all reproductive options are available in the Netherlands, participants should have an active child wish (within 5 years), and the female partner should be of reproductive age (18-41 years). Additionally, couples should have sufficient knowledge of the Dutch language and ample experience with the use of computers and internet.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Being pregnant at time of inclusion.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9415 |
| Ander register | Issueing body: Medical Ethics Committee Maastricht University Medical Centre +. : Niet-WMO METC 2019-1278 |