Use of eHealth in Communication With Patients About Prenatal Diagnosis (HIIP)

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

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice; Downs Syndrome
• Intervention / Treatment: Behavioral: Access to the website www.graviditetsportalen.dk; Behavioral: Access to the website www.ouh.dk

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 Type: Interventional
• Enrollment (Actual): 1150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region of Southern Denmark
    • Odense, Region of Southern Denmark, Denmark, 5000
      • Odense University Hospital, Department of Gynaecology and Obstetrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Website
Placebo Comparator: Access to the website www.ouh.dk; Access to the usual information from the hospital website	Behavioral: Access to the website www.ouh.dk; Access to the usual information from the hospital website

What is the study measuring?

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	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.

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Mette Maria Skjoeth, PhD Student, Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics; Study Chair: Jan Stener Joergensen, Associate professor, Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics; Study Chair: Claus Duedal Pedersen, Head of Innovation Unit, Odense University Hospital, The LEAN and Innovation Unit; Study Chair: Eva Draborg, Associate professor, University of Southern Denmark, Centre of Health Economics Research - Institute of Public Health; Study Chair: Helle Ploug Hansen, Professor, University of Southern Denmark, The Institute of Public Health

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 19, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Screening; eHealth; Downs syndrome; Informed choice
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Down Syndrome
• Other Study ID Numbers: HIIP