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Decision Aid for Gender Dysphoria
N/A
Waitlist Available
Led By Rachel A. Moses, MD, MPH
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Assigned female on the original birth certificate
Aged 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-decision aid use, and post-surgical consultation (dates vary, approximately 2-6 weeks from baseline).
Awards & highlights
Summary
This trial aims to test a new online tool that provides information to help individuals considering Gender Affirming Surgery make informed decisions. Participants will either receive standard care or use the web-based decision aid and provide
Who is the study for?
This trial is for transgender individuals considering gender-affirming surgeries, specifically metoidioplasty and phalloplasty. Participants should be in the decision-making process regarding these surgeries and willing to provide feedback on a new online decision aid tool.
What is being tested?
The study tests an online tool designed to help with decisions about Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS). It compares the experiences of those using this tool against those receiving standard care, focusing on user-friendliness and its impact on surgery readiness.
What are the potential side effects?
Since this trial involves an informational decision aid rather than a medical intervention, there are no direct physical side effects. However, participants may experience emotional or psychological responses related to engaging with information about surgical options.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was assigned female at birth.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within one week following the surgical consultation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within one week following the surgical consultation.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Decisional Conflict Scale (DCS) Score Change
Preparation for Decision Making (PrepDM) Scale Score Change
Secondary study objectives
CollaboRATE Score Change Post-Surgical Consultation
System Usability Scale (SUS) Score
Other study objectives
Qualitative Feedback from Cognitive Interviews
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MaPGAS Decision Aid InterventionExperimental Treatment1 Intervention
Participants in this arm will be provided with access to a novel, web-based decision aid designed for individuals considering MaPGAS. The decision aid includes interactive components, educational materials regarding surgical options, risks, benefits, and patient testimonials. Participants will have unlimited access to the decision aid for four weeks prior to their surgical consultation.
Group II: MaPGAS Usual CareActive Control1 Intervention
Participants in this arm will receive the standard pre-consultation care provided by their healthcare provider, which does not include access to the novel decision aid. Standard care may include informational brochures. This group serves to compare the outcomes of traditional decision-making processes with those who use the decision aid.
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Who is running the clinical trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
536 Previous Clinical Trials
2,539,547 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,751 Total Patients Enrolled
Dartmouth CollegeOTHER
86 Previous Clinical Trials
1,419,384 Total Patients Enrolled
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