i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

Gender Dysphoria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290286
• Other study ID #: i2TransHealth
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: September 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gender Dysphoria
• Gender Identity
• Gender Identity Disorder
• Gender Incongruence
• Transsexualism

Intervention

Other:
• i2TransHealth
i2TransHealth: online intervention for TGD people

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)]
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   https://www.i2transhealth.de/english-landing-page/