Clinical trial NCT01889550: Use of eHealth in Communication With Patients About Prenatal Diagnosis
Official title: Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Downs Syndrome
Health Knowledge, Attitudes, Practice
Keywords: Screening
Downs syndrome
Informed choice
eHealth
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 1150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional measure of informed choice (MMIC)
timeFrame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
Secondary outcomes:
measure: Decisional Conflict Scale
timeFrame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
measure: WHO well-being index
timeFrame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
measure: Cambridge Worry Scale
timeFrame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Department of Gynaecology and Obstetrics
state: Region of Southern Denmark
Study officials:
affiliation: Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics
name: Mette Maria Skjoeth, PhD Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics
name: Jan Stener Joergensen, Associate professor
role: STUDY_CHAIR
affiliation: Odense University Hospital, The LEAN and Innovation Unit
name: Claus Duedal Pedersen, Head of Innovation Unit
role: STUDY_CHAIR
affiliation: University of Southern Denmark, Centre of Health Economics Research - Institute of Public Health
name: Eva Draborg, Associate professor
role: STUDY_CHAIR
affiliation: University of Southern Denmark, The Institute of Public Health
name: Helle Ploug Hansen, Professor
role: STUDY_CHAIR
References: