MaPGAS Decision Making

Part of paid clinical trials in Hanover, New Hampshire.

Sponsor
Dartmouth-Hitchcock Medical Center
Study ID
NCT06565663
Status
Enrolling By Invitation

Conditions

  • Gender Dysphoria
  • Gender Dysphoria, Adult
  • Gender Incongruence
  • Phalloplasty
  • Transgender Persons
  • Transgenderism
  • Transsexualism

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MaPGAS Decision Aid — BEHAVIORAL
    This intervention involves a novel, web-based decision aid tool specifically designed to support transgender and non-binary individuals assigned female at birth in making informed decisions about Metoidioplasty and Phalloplasty Gender Affirming Surgeries (MaPGAS). The tool includes comprehensive information on surgical options, risks, benefits, and medical illustrations to aid in aligning surgical decisions with the individual's personal values and goals.

Study Details

The goal of this clinical trial is to test a new online tool designed to provide clear and understandable information to help individuals considering Metoidioplasty and Phalloplasty Gender Affirming Surgery (MaPGAS)make informed decisions The main questions it aims to answer are: * How user-friendly is the decision aid for individuals considering metoidioplasty and phalloplasty? * Does using the decision aid reduce uncertainty and improve readiness for making surgery decisions compared to usual care? Participants in this study will: * Be randomly assigned to either 1) receive usual care or 2) test the web-based decision aid. * Share their feedback on the tool's usability and its helpfulness in supporting decision-making. * Complete surveys before and after using the decision aid to measure any changes in their decision-making process. Researchers will compare participants who used the decision aid with those who received standard care to see if the decision aid reduces decisional uncertainty and improves readiness for surgery.

Key Dates

Start date
Oct 23, 2024
Status verified
Nov 2025
Primary completion
Feb 2, 2028
Completion
Mar 6, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: MaPGAS Decision Aid 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.
  • No Intervention: MaPGAS Usual Care
    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.

Primary Outcome Measure

Decisional Conflict Scale (DCS) Score Change [ Time Frame: Baseline (within 1-2 weeks prior to using the decision aid) and follow-up (immediately after decision aid use, approximately 2-4 weeks later). ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dartmouth CollegeHanoverNew Hampshire03755-
University of UtahSalt Lake CityUtah84112-

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By research site
Dartmouth College· Hanover, NHUniversity of Utah· Salt Lake City, UT

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