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

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ClinicalTrials.gov Identifier: NCT01889550
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Mette Maria Skjoeth, 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.


Condition or disease Intervention/treatment Phase
Downs Syndrome Health Knowledge, Attitudes, Practice Behavioral: Access to the website www.graviditetsportalen.dk Behavioral: Access to the website www.ouh.dk Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
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 Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Multidimensional measure of informed choice (MMIC) [ Time Frame: 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 :
  1. Decisional Conflict Scale [ Time Frame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan. ]
  2. WHO well-being index [ Time Frame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan. ]
  3. Cambridge Worry Scale [ Time Frame: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889550


Locations
Denmark
Odense University Hospital, Department of Gynaecology and Obstetrics
Odense, Region of Southern Denmark, Denmark, 5000
Sponsors and Collaborators
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

Responsible Party: Mette Maria Skjoeth, PhD Student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01889550     History of Changes
Other Study ID Numbers: HIIP
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Mette Maria Skjoeth, Odense University Hospital:
Screening
Downs syndrome
Informed choice
eHealth

Additional relevant MeSH terms:
Down Syndrome
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn