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

Primary Purpose

Downs Syndrome, Health Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Access to the website www.graviditetsportalen.dk
Access to the website www.ouh.dk
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Downs Syndrome focused on measuring Screening, Downs syndrome, Informed choice, eHealth

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital, Department of Gynaecology and Obstetrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Access to the website www.graviditetsportalen.dk

Access to the website www.ouh.dk

Arm Description

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 usual information from the hospital website

Outcomes

Primary Outcome Measures

Multidimensional measure of informed choice (MMIC)
Questionnaire for assessing knowledge of prenatal screening for Downs syndrome

Secondary Outcome Measures

Decisional Conflict Scale
WHO well-being index
Cambridge Worry Scale

Full Information

First Posted
June 19, 2013
Last Updated
October 15, 2014
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01889550
Brief Title
Use of eHealth in Communication With Patients About Prenatal Diagnosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Downs Syndrome, Health Knowledge, Attitudes, Practice
Keywords
Screening, Downs syndrome, Informed choice, eHealth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
1150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Access to the website www.graviditetsportalen.dk
Arm Type
Active Comparator
Arm Description
The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.
Arm Title
Access to the website www.ouh.dk
Arm Type
Placebo Comparator
Arm Description
Access to the usual information from the hospital website
Intervention Type
Behavioral
Intervention Name(s)
Access to the website www.graviditetsportalen.dk
Other Intervention Name(s)
Website
Intervention Description
The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.
Intervention Type
Behavioral
Intervention Name(s)
Access to the website www.ouh.dk
Intervention Description
Access to the usual information from the hospital website
Primary Outcome Measure Information:
Title
Multidimensional measure of informed choice (MMIC)
Description
Questionnaire for assessing knowledge of prenatal screening for Downs syndrome
Time Frame
Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Maria Skjoeth, PhD Student
Organizational Affiliation
Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Stener Joergensen, Associate professor
Organizational Affiliation
Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claus Duedal Pedersen, Head of Innovation Unit
Organizational Affiliation
Odense University Hospital, The LEAN and Innovation Unit
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eva Draborg, Associate professor
Organizational Affiliation
University of Southern Denmark, Centre of Health Economics Research - Institute of Public Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helle Ploug Hansen, Professor
Organizational Affiliation
University of Southern Denmark, The Institute of Public Health
Official's Role
Study Chair
Facility Information:
Facility Name
Odense University Hospital, Department of Gynaecology and Obstetrics
City
Odense
State/Province
Region of Southern Denmark
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

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Use of eHealth in Communication With Patients About Prenatal Diagnosis

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