Use of eHealth in Communication With Patients About Prenatal Diagnosis
HIIP
1 other identifier
interventional
1,150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 16, 2014
October 1, 2014
1 year
June 19, 2013
October 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Study Arms (2)
Access to the website www.graviditetsportalen.dk
ACTIVE COMPARATORThe 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
PLACEBO COMPARATORAccess to the usual information from the hospital website
Interventions
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
Eligibility Criteria
You may qualify if:
- Pregnant women participating in screening for Downs syndorme
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital, Department of Gynaecology and Obstetrics
Odense, Region Syddanmark, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 28, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 16, 2014
Record last verified: 2014-10