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i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04290286
Recruitment Status : Completed
First Posted : February 28, 2020
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
Timo Nieder, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gender Dysphoria Gender Identity Disorder Transsexualism Gender Identity Gender Incongruence Other: i2TransHealth Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Interdisciplinary, Internet-based Trans Health Care (i2TransHealth): A Randomized Controlled Trial
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : May 31, 2022
Actual Study Completion Date : September 30, 2022
Arms and Interventions
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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)
 Other: i2TransHealth
i2TransHealth: online intervention for TGD people
No Intervention: waiting group
TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290286


Locations
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Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Timo Nieder, PI: Timo Nieder, PhD ECPS, Head of Outpatient Unit for Sexual Health and Transgender Care, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry (Co-PI: Arne Dekker, PhD, Peer Briken, MD FECSM Prof)), Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04290286    
Other Study ID Numbers: i2TransHealth
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gender Dysphoria
Sexual Dysfunctions, Psychological
Mental Disorders