FertiScreen: an Online Application to Improve the Quality of Fertility Care
NCT ID: NCT01820039
Last Updated: 2013-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
152 participants
INTERVENTIONAL
2013-06-30
Brief Summary
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Methods The investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. Couples consulting their general practitioner with an unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis antibody titre and semen analysis). FertiScreen then uses the validated prediction model of Hunault to calculate couples' chance of natural conception during the next twelve months. In addition, patients can find links to extra information concerning subfertility. Couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. When the calculated prognosis of spontaneous conception within one year is \>30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment.
Questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability Scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for Infertility.
In order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. Their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the System Usability Scale).
The investigators will recruit couples presenting to general practitioners in the Nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). To detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (P\<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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FertiScreen
all patients between 18 and 38 years, consulting their general practitioner for infertility will be asked to use FertiScreen.
FertiScreen
FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.
Interventions
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FertiScreen
FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.
Eligibility Criteria
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Inclusion Criteria
* women \>18 years and \<38 years
* one of the partners Dutch speaking
* access to the Internet
* residing in the Netherlands
* unfulfilled childwish for at least 6 months
18 Years
37 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jan AM Kremer, MD, PhD
Role: STUDY_DIRECTOR
IQ Healthcare, UMC St Radboud, Nijmegen, The Netherlands
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, PO Box 9101, Netherlands
Countries
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Central Contacts
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Other Identifiers
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FertiScreen
Identifier Type: -
Identifier Source: org_study_id