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NCT Number: NCT04290286

i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

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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Key information

Conditions

Gender Dysphoria Behavior Gender Identity Gender Identity Disorder Gender Incongruence Mental Disorders Sexual Behavior Sexual Dysfunctions, Psychological Sexuality Transsexualism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

i2TransHealth

Other

i2TransHealth: online intervention for TGD people

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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)

    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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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