Health Knowledge, Attitudes, Practice Clinical Trial
— HIIPOfficial title:
Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics
Verified date | October 2014 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1150 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital, Department of Gynaecology and Obstetrics | Odense | Region of Southern Denmark |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | 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. | No | |
Secondary | 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. | No | |
Secondary | 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. | No |
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