i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Gender Dysphoria, Gender Identity Disorder, Transsexualism, Gender Identity, Gender Incongruence

Intervention / Treatment
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* Other: i2TransHealth


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group) | Other: i2TransHealth<br>* i2TransHealth: online intervention for TGD people<br>|
| No Intervention: waiting group<br>TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden according to BSI-18 | References: Franke, G. H. (2000). Franke, G.H. (2000). BSI. Brief Symptom Inventory - Deutsche Version. Manual. Göttingen: Beltz. | Change from Baseline Mental Health Symptoms to the point of time after online intervention (Baseline + 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (physical health, psychological health, social relationships, and environment) | QoL is measured using the WHOQOL-BREF (WHO, 1998). References: Angermeyer, M. C., Kilian, R., & Matschinger, H. (2000). WHOQOL - WHOQOL-100 und WHOQOL-BREF. Handbuch für die deutschsprachigen Versionen der WHO Instrumente zur Erfassung von Lebensqualität. WHO (1998). Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychological medicine, 28(3), 551-558. | Change from Baseline QoL to the point of time after online intervention (Baseline + 4 months)] | 
| Treatment satisfaction according to modified version ZUF-8 | References: Schmidt, J., Lamprecht, F., & Wittmann, W. W. (1989). Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. [Satisfaction with inpatient care: Development of a questionnaire and first validity assessments.]. PPmP: Psychotherapie Psychosomatik Medizinische Psychologie, 39(7), 248-255. | Treatment satisfaction at the point of time after online intervention (4 months after admission to studies) | 
| Direct or indirect costs and productivity losses by persons with TS/GD in comparison to the German general population (via CSSRI) | References: Chisholm, D., Knapp, M. R. J., Knudsen, H. C., Amaddeo, F., Gaite, L., Wijngaarden, B. van, & Group, E. S. (2000). Client Socio-Demographic and Service Receipt Inventory - European Version: Development of an instrument for international research: EPSILON Study 5. The British Journal of Psychiatry, 177(S39), s28-s33. https://doi.org/10.1192/bjp.177.39.s28 | Change from Baseline to the point of time after online intervention (Baseline + 4 months) | 
| Health-related quality of life (via EQ-5D-5L): quality-adjusted life years (QALYs) | References: Herdman, M., Gudex, C., Lloyd, A., Janssen, MF., Kind, P., Parkin, D., … Badia, X. (2011). Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality of Life Research, 20(10), 1727-1736. https://doi.org/10.1007/s11136-011-9903-x | Change from Baseline to the point of time after online intervention (Baseline + 4 months) | 
| Knowledge increase of the cooperating physicians on trans health care (via VSE) | References: Raupach, T., Schiekirka, S., Münscher, C., Beißbarth, T., Himmel, W., Burckhardt, G., & Pukrop, T. (2012). Implementierung und Erprobung eines Lernziel-basierten Evaluationssystems im Studium der Humanmedizin. GMS Zeitschrift für medizinische Ausbildung, 29(3), 1-14. | Change from Baseline to the point of time after study completion (Baseline + 18 months) | 
| Satisfaction of the cooperating physicians with the support in the i2TransHealth network (via modified version ZUF-8) | References: Schmidt, J., Lamprecht, F., & Wittmann, W. W. (1989). Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. [Satisfaction with inpatient care: Development of a questionnaire and first validity assessments.]. PPmP: Psychotherapie Psychosomatik Medizinische Psychologie, 39(7), 248-255. | Satisfaction at the point of time after study completion (18 months) |