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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

Tracking Information
First Submitted Date  ICMJE June 19, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date October 16, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • 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. ]
  • 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. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of eHealth in Communication With Patients About Prenatal Diagnosis
Official Title  ICMJE Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Downs Syndrome
  • Health Knowledge, Attitudes, Practice
Intervention  ICMJE
  • 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
  • Behavioral: Access to the website www.ouh.dk
    Access to the usual information from the hospital website
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Access to the website www.graviditetsportalen.dk
  • Placebo Comparator: Access to the website www.ouh.dk
    Access to the usual information from the hospital website
    Intervention: Behavioral: Access to the website www.ouh.dk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
1150
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
600
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889550
Other Study ID Numbers  ICMJE HIIP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mette Maria Skjoeth, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Odense University Hospital
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP