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i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

U

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Gender Identity Disorder
Gender Identity
Gender Dysphoria
Gender Incongruence
Transsexualism

Treatments

Other: i2TransHealth

Study type

Interventional

Funder types

Other

Identifiers

NCT04290286
i2TransHealth

Details and patient eligibility

About

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.

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 years or older
  • Gender different from their assigned sex at birth
  • resident at least 50 km outside Hamburg
  • present themselves with treatment needs (TS/GD) to one of the participating physicians in the i2TransHealth network, or direct contact with institute and/or e-health platform
  • receive the suspected diagnosis TS/GD during an initial interview in the UKE
  • can operate the video chat cognitively, verbally and auditory
  • Able to read, speak, and understand German
  • Written informed consent after written and oral information

Exclusion criteria

  • Under 18 years of age
  • Missing informed consent
  • Unable to speak German
  • Indication for inpatient treatment, e.g. due to acute psychotic symptoms (self-report, Prodromal Questionnaire, PQ-B) or severe depressive symptoms (self-report, BDI-II ≥ 29)
  • Acute suicidal tendencies
  • Decrease in intelligence (IQ below 70)
  • Acute drug intoxication
  • Failure to meet technical requirements (no Internet access, lack of IT knowledge)

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

186 participants in 2 patient groups

intervention group
Experimental group
Description:
TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)
Treatment:
Other: i2TransHealth
waiting group
No Intervention group
Description:
TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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