Use of eHealth in Communication With Patients About Prenatal Diagnosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics

Conditions
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Downs Syndrome, Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Behavioral: Access to the website www.graviditetsportalen.dk
* Behavioral: Access to the website www.ouh.dk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women participating in screening for Downs syndorme 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Access to the website www.graviditetsportalen.dk<br>The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics. | Behavioral: Access to the website www.graviditetsportalen.dk<br>* The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.<br>* Other names: Website;|
| Placebo Comparator: Access to the website www.ouh.dk<br>Access to the usual information from the hospital website | Behavioral: Access to the website www.ouh.dk<br>* Access to the usual information from the hospital website<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, Screening, Downs syndrome, Informed choice