No registrations found.
ID
Source
Brief title
Health condition
Hereditary Diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decisional conflict. This will be assessed by means of the Decisional Conflict Scale (O’Connor, 1995).
Secondary outcome
Secondary outcome measures include knowledge and realistic expectations of different reproductive options (e.g. accuracy of perceived risks), deliberation (van den Berg et al., 2006), attitude , joint informed decision-making and preparation for decision making (Bennett et al., 2010). The Multidimensional Measure of Informed Choice (MMIC; Marteau et al., 2001) will be used to assess informed choice.
Background summary
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).
Study objective
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
Study design
Baseline (before intervention, T0), immediately after viewing the DA/standardized information intervention, (T1) after 1 month (T2) and after 6 months (T3).
Intervention
Decision aid with written and visual information, including value clarification methods (VCMs).
Inclusion criteria
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.
Exclusion criteria
Being pregnant at time of inclusion.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9415 |
| Other | Issueing body: Medical Ethics Committee Maastricht University Medical Centre +. : Niet-WMO METC 2019-1278 |