i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

• ClinicalTrials.gov Identifier: NCT04290286
• Recruitment Status: Completed
• First Posted: February 28, 2020
• Last Update Posted: November 4, 2022
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Information provided by (Responsible Party): Timo Nieder, Universitätsklinikum Hamburg-Eppendorf

Tracking Information

• First Submitted Date: February 26, 2020
• First Posted Date: February 28, 2020
• Last Update Posted Date: November 4, 2022
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2020)

• 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.
• 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.
• 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
• 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
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Health Services Research

Condition

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

Intervention

Other: i2TransHealth

i2TransHealth: online intervention for TGD people

Study Arms

• Experimental: intervention group
  TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)
  Intervention: Other: i2TransHealth
• No Intervention: waiting group
  TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2022): 186
• Original Estimated Enrollment (submitted: February 26, 2020): 210
• Actual Study Completion Date: September 30, 2022
• Actual Primary Completion Date: May 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT04290286
• Other Study ID Numbers: i2TransHealth
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Timo Nieder, Universitätsklinikum Hamburg-Eppendorf
• Original Responsible Party: Timo Nieder, Universitätsklinikum Hamburg-Eppendorf, Timo Nieder, PhD
• Current Study Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universitätsklinikum Hamburg-Eppendorf
• Verification Date: November 2022