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

O

Odense University Hospital

Status

Completed

Conditions

Downs Syndrome
Health Knowledge, Attitudes, Practice

Treatments

Behavioral: Access to the website www.graviditetsportalen.dk
Behavioral: Access to the website www.ouh.dk

Study type

Interventional

Funder types

Other

Identifiers

NCT01889550
HIIP

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,150 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,150 participants in 2 patient groups, including a placebo group

Access to the website www.graviditetsportalen.dk
Active Comparator group
Description:
The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.
Treatment:
Behavioral: Access to the website www.graviditetsportalen.dk
Access to the website www.ouh.dk
Placebo Comparator group
Description:
Access to the usual information from the hospital website
Treatment:
Behavioral: Access to the website www.ouh.dk

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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