Downs SyndromeHIIPNCT01889550
Use of eHealth in Communication With Patients About Prenatal Diagnosis
A study testing Access to the website www.graviditetsportalen.dk and Access to the website www.ouh.dk in people with Downs Syndrome and Health Knowledge, Attitudes, Practice, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Downs Syndrome, Health Knowledge, Attitudes, Practice
- What is being tested?
- Access to the website www.graviditetsportalen.dk and Access to the website www.ouh.dk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,150 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women participating in screening for Downs syndorme
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Odense University Hospital, Department of Gynaecology and Obstetrics
Odense, Region Syddanmark, 5000
About this study
Official title: Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics
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.
Read the 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.
- Being tested
- Access to the website www.graviditetsportalen.dk, Access to the website www.ouh.dk
- Keywords
- Screening, Downs syndrome, Informed choice, eHealth
- Medical subject headings
- Down Syndrome, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to the website www.graviditetsportalen.dkBehavioural
Also called Website
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 website www.ouh.dkBehavioural
Access to the usual information from the hospital website
| Study group | Role | What they receive |
|---|---|---|
| Access to the website www.graviditetsportalen.dk | Active comparator | The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics. Receives: Behavioral: Access to the website www.graviditetsportalen.dk |
| Access to the website www.ouh.dk | Placebo comparator | Access to the usual information from the hospital website Receives: Behavioral: Access to the website www.ouh.dk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional measure of informed choice (MMIC)
Questionnaire for assessing knowledge of prenatal screening for Downs syndrome
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be asked to compleete the questionnaire in an expected average of 6 weeks after having had the nuchal translucency scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Downs SyndromeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Maria Skjoeth, Odense University Hospital
- Investigators
- Mette Maria Skjoeth, PhD Student, Principal investigator, Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and ObstetricsJan Stener Joergensen, Associate professor, Study chair, Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and ObstetricsClaus Duedal Pedersen, Head of Innovation Unit, Study chair, Odense University Hospital, The LEAN and Innovation UnitEva Draborg, Associate professor, Study chair, University of Southern Denmark, Centre of Health Economics Research - Institute of Public HealthHelle Ploug Hansen, Professor, Study chair, University of Southern Denmark, The Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889550
- Sponsor's protocol ID
- HIIP
- Acronym
- HIIP
- Status last verified
- Oct 2014
- First submitted
- 19 Jun 2013
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of eHealth in Communication With Patients About Prenatal Diagnosis. An Intervention Study Carried Out in a Highly Specialised Unit for Obstetrics
- ClinicalTrials.gov ID
- NCT01889550
- Acronym / sponsor ID
- HIIP / HIIP
- Keywords
- Screening, Downs syndrome, Informed choice, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to the website www.graviditetsportalen.dk | Active comparator | Behavioral: Access to the website www.graviditetsportalen.dkThe 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 comparator | Behavioral: Access to the website www.ouh.dkAccess to the usual information from the hospital website |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women participating in screening for Downs syndorme
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to the website www.graviditetsportalen.dkAlso: WebsiteThe website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics. | Behavioural | Access to the website www.graviditetsportalen.dk |
| Access to the website www.ouh.dkAccess to the usual information from the hospital website | Behavioural | Access to the website www.ouh.dk |
Primary outcome
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
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Maria Skjoeth, PhD Student principal investigator
Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics
Jan Stener Joergensen, Associate professor study chair
Odense University Hospital, Department of Gynaecology and Obstetrics, University of Southern Denmark, Institute of Clinical research, Research Unit of Gynaecology and Obstetrics
Claus Duedal Pedersen, Head of Innovation Unit study chair
Odense University Hospital, The LEAN and Innovation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to the website www.graviditetsportalen.dk and Access to the website www.ouh.dk in people with Downs Syndrome and Health Knowledge, Attitudes, Practice, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.