CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 186 enrolled
Drug / intervention
i2TransHealthother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04290286
NCT04290286N/ACompleted

Interdisciplinary, Internet-based Trans Health Care (i2TransHealth): A Randomized Controlled Trial

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Feb 28, 2020·Updated Nov 4, 2022

In Brief

A clinical study evaluating i2TransHealth for Gender Dysphoria and 4 related conditions. Completed, enrolled 186 participants across 1 site.

Detailed Summary

i2TransHealth is a randomized controlled trial that investigates the outcomes of an internet-based health care approach for transgender and gender diverse (TGD) people. As a health services research project, i2TransHealth aims at reducing the structural disadvantage for TGD people \[people with transsexualism (TS: ICD-10), gender incongruence (GIC: ICD-11) and/or gender dysphoria (GD: DSM-5)\] living in areas lacking specialized transition-related treatment. Located at the Institute for Sex Research and in cooperation with the Interdisciplinary Transgender Health Care Center Hamburg (ITHCCH), both University Medical Center Hamburg-Eppendorf (UKE), i2TransHealth is an innovative intervention including video consultation and a 1:1 chat with clinical psychologists. By cooperating with the ITHCCH, general physicians and psychiatrists provide first and local access to the specialized treatment provided by the UKE. In the intervention group, the study participants are invited to use the i2TransHealth e-health platform including a video consultation hour every two weeks and a messenger between the video-meetings. In addition, they have the opportunity to receive medical support close to their home by licensed GPs and psychiatrists according to their needs (especially in case of a somatic or mental health crisis). The waiting group participants will be able to go forward with transition-related care after four months of study participation, as part of regular care. The primary outcome measure is a reduced symptomatology for TGD people (BSCL). Secondary outcome parameters include quality of life and patient satisfaction as well as healthcare-related costs and cost-effectiveness. Finally, based on a longitudinal design, it will be assessed if the physicians improve their TGD-related expertise by cooperating within the i2TransHealth-network.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartMay 1, 2020
Primary CompletionMay 31, 2022
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.3 years ago

Interventions

i2TransHealthother

i2TransHealth: online intervention for TGD people