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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group) |
|
| waiting group | No Intervention | TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i2TransHealth | Other | i2TransHealth: online intervention for TGD people |
|
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41891088 | Derived | Renner J, Briken P, Dekker A, Pregartbauer L, Zapf A, Sehner S, Pepic A, Augustin M, Nieder TO. Which transgender and gender diverse groups benefit most from E-health? Subgroup analyses of the randomized controlled trial i2TransHealth in Germany. Int J Transgend Health. 2025 Feb 22;27(2):824-839. doi: 10.1080/15532739.2025.2465710. eCollection 2026. | |
| 41580775 |
| Label | URL |
|---|---|
| https://www.i2transhealth.de/english-landing-page/ | View source |
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| D014189 | Transsexualism |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
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| 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) |
| Schmidt F, Renner J, Schroder SI, Pregartbauer L, Dekker A, Nieder TO. Enabling and hindering aspects of the i(2)TransHealth e-health intervention for transgender and gender diverse people in Germany: a qualitative process evaluation. BMC Health Serv Res. 2026 Jan 24;26(1):149. doi: 10.1186/s12913-026-14026-y. |
| 40204312 | Derived | Grochtdreis T, Konnopka A, Renner J, Konig HH, Dekker A, Briken P, Nieder T, Dams J. Excess costs of transgender and gender-diverse people with gender incongruence and gender dysphoria compared with people from the general population in Germany: a secondary analysis using data from a randomised controlled trial and a representative telephone survey. BMJ Open. 2025 Apr 9;15(4):e089663. doi: 10.1136/bmjopen-2024-089663. |
| 39419729 | Derived | Nieder TO, Renner J, Sehner S, Pepic A, Zapf A, Lambert M, Briken P, Dekker A. Effect of the i2TransHealth e-health intervention on psychological distress among transgender and gender diverse adults from remote areas in Germany: a randomised controlled trial. Lancet Digit Health. 2024 Dec;6(12):e883-e893. doi: 10.1016/S2589-7500(24)00192-4. Epub 2024 Oct 16. |
| 35105559 | Derived | Nieder TO, Renner J, Zapf A, Sehner S, Hot A, Konig HH, Dams J, Grochtdreis T, Briken P, Dekker A. Interdisciplinary, internet-based trans health care (i(2)TransHealth): study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 1;12(2):e045980. doi: 10.1136/bmjopen-2020-045980. |
| D001519 |
| Behavior |