Use of eHealth in Communication With Patients About Prenatal Diagnosis

Not Applicable

Completed

• Conditions: Health Knowledge, Attitudes, Practice; Downs Syndrome
• Interventions: Behavioral: Access to the website www.ouh.dk; Behavioral: Access to the website www.graviditetsportalen.dk

• Registration Number: NCT01889550
• Lead Sponsor: Odense University Hospital

Brief Summary

The research aims at generating new knowledge about ways to inform pregnant women about prenatal screening for Downs syndrome.

The overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for Downs syndrome, and thereby an option to make an informed choice. The project is planned as a research into whether the use of an eHealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

Detailed Description

Prenatal screening and diagnosis is testing for diseases or rare conditions in the fetus before birth. The aim is to assist the pregnant women to make their own decisions, and neutral and adequate counseling is a prerequisite during prenatal diagnosis. To make an informed choice, the pregnant women must be informed about the benefits and potential disadvantages of prenatal diagnosis and with this background be able to make a comprehensive evaluation, where ethical values will have a high impact.

The overall purpose of this project is to increase pregnant women's knowledge of prenatal screening for Downs syndrome, and thereby an option to make an informed choice. The project is planned as a research into whether the use of an eHealth solution (in this project an interactive website) may be an appropriate intervention for pregnant women.

Methods:

Part one consists of an identification of the problem

Part two consists of developing a website with relevant information about prenatal screening for Downs syndrome.

Part three is an effect measurement. The effect of the intervention is measured through a randomized controlled trail in which the essentials of the measurement will be the pregnant women's knowledge and behavior in relation to prenatal diagnosis. Twice 300 pregnant women will be included in the project.

Results:

The research aims at generating new knowledge about ways to inform pregnant women about prenatal diagnosis and prenatal screening. The expected results are:

* Higher knowledge about prenatal diagnosis for the pregnant women.

* Less difficulty in making an informed choice for the coming parents.

* Easy access to high quality information.

* Equity in access to high quality information.

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-27
• Study First Posted: 2013-06-28
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1150

Inclusion Criteria

• Pregnant women participating in screening for Downs syndorme

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Exclusion Criteria

• Respondents who do not speak, read and understand Danish.
• Respondents who have opted out of health care services and prenatal diagnosis.
• Reespondenter who do not wish to participate.
• Respondents under 18 years.
• Respondents with a strong suspicion of threatening abortion
• Respondents whom are vulnerable
• Respondents with a late referral

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Access to the website www.ouh.dk	Access to the website www.ouh.dk	Access to the usual information from the hospital website
Access to the website www.graviditetsportalen.dk	Access to the website www.graviditetsportalen.dk	The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.

Primary Outcome Measures

Name	Time	Method
Multidimensional measure of informed choice (MMIC)	Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.	Questionnaire for assessing knowledge of prenatal screening for Downs syndrome

Secondary Outcome Measures

Name	Time	Method
Cambridge Worry Scale	Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
Decisional Conflict Scale	Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
WHO well-being index	Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.

Trial Locations

Locations (1)

Odense University Hospital, Department of Gynaecology and Obstetrics; 🇩🇰 Odense, Region of Southern Denmark, Denmark