- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04290286
i2TransHealth: Interdisciplinary, Internet-based Trans Health Care
Interdisciplinary, Internet-based Trans Health Care (i2TransHealth): A Randomized Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)
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i2TransHealth: online intervention for TGD people
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No Intervention: waiting group
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom burden according to BSI-18
Time Frame: Change from Baseline Mental Health Symptoms to the point of time after online intervention (Baseline + 4 months)
|
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)
Time Frame: Change from Baseline QoL to the point of time after online intervention (Baseline + 4 months)]
|
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
Time Frame: Treatment satisfaction at the point of time after online intervention (4 months after admission to studies)
|
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)
Time Frame: Change from Baseline to the point of time after online intervention (Baseline + 4 months)
|
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)
Time Frame: Change from Baseline to the point of time after online intervention (Baseline + 4 months)
|
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)
Time Frame: Change from Baseline to the point of time after study completion (Baseline + 18 months)
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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)
Time Frame: Satisfaction at the point of time after study completion (18 months)
|
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)
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- i2TransHealth
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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