i2TransHealth: Interdisciplinary, Internet-based Trans Health Care
Primary Purpose
Gender Dysphoria, Gender Identity Disorder, Transsexualism
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
i2TransHealth
Sponsored by
About this trial
This is an interventional health services research trial for Gender Dysphoria
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)
Sites / Locations
- University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
waiting group
Arm Description
TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)
TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation
Outcomes
Primary Outcome Measures
Symptom burden according to BSI-18
References:
Franke, G. H. (2000). Franke, G.H. (2000). BSI. Brief Symptom Inventory - Deutsche Version. Manual. Göttingen: Beltz.
Secondary Outcome Measures
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.
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.
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
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
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.
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.
Full Information
NCT ID
NCT04290286
First Posted
February 26, 2020
Last Updated
November 3, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT04290286
Brief Title
i2TransHealth: Interdisciplinary, Internet-based Trans Health Care
Official Title
Interdisciplinary, Internet-based Trans Health Care (i2TransHealth): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria, Gender Identity Disorder, Transsexualism, Gender Identity, Gender Incongruence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)
Arm Title
waiting group
Arm Type
No Intervention
Arm Description
TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation
Intervention Type
Other
Intervention Name(s)
i2TransHealth
Intervention Description
i2TransHealth: online intervention for TGD people
Primary Outcome Measure Information:
Title
Symptom burden according to BSI-18
Description
References:
Franke, G. H. (2000). Franke, G.H. (2000). BSI. Brief Symptom Inventory - Deutsche Version. Manual. Göttingen: Beltz.
Time Frame
Change from Baseline Mental Health Symptoms to the point of time after online intervention (Baseline + 4 months)
Secondary Outcome Measure Information:
Title
Quality of Life (physical health, psychological health, social relationships, and environment)
Description
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.
Time Frame
Change from Baseline QoL to the point of time after online intervention (Baseline + 4 months)]
Title
Treatment satisfaction according to modified version ZUF-8
Description
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.
Time Frame
Treatment satisfaction at the point of time after online intervention (4 months after admission to studies)
Title
Direct or indirect costs and productivity losses by persons with TS/GD in comparison to the German general population (via CSSRI)
Description
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
Time Frame
Change from Baseline to the point of time after online intervention (Baseline + 4 months)
Title
Health-related quality of life (via EQ-5D-5L): quality-adjusted life years (QALYs)
Description
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
Time Frame
Change from Baseline to the point of time after online intervention (Baseline + 4 months)
Title
Knowledge increase of the cooperating physicians on trans health care (via VSE)
Description
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.
Time Frame
Change from Baseline to the point of time after study completion (Baseline + 18 months)
Title
Satisfaction of the cooperating physicians with the support in the i2TransHealth network (via modified version ZUF-8)
Description
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.
Time Frame
Satisfaction at the point of time after study completion (18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35105559
Citation
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.
Results Reference
derived
Links:
URL
https://www.i2transhealth.de/
Description
https://www.i2transhealth.de/english-landing-page/
Learn more about this trial
i2TransHealth: Interdisciplinary, Internet-based Trans Health Care
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