Use of eHealth in Communication With Patients About Prenatal Diagnosis

Health Knowledge, Attitudes, Practice Clinical Trial

— HIIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889550
• Other study ID #: HIIP
• Status: Completed
• Phase: N/A
• First received: June 19, 2013
• Last updated: October 15, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Down Syndrome
• Downs Syndrome
• Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
• 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.
• Access to the website www.ouh.dk
Access to the usual information from the hospital website

Locations

Country	Name	City	State
Denmark	Odense University Hospital, Department of Gynaecology and Obstetrics	Odense	Region of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No