Interdisciplinary, Internet-based Trans Health Care (i2TransHealth): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Symptom burden according to BSI-18
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Symptom burden according to BSI-18
时间窗: 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.
次要结局
- Direct or indirect costs and productivity losses by persons with TS/GD in comparison to the German general population (via CSSRI)(Change from Baseline to the point of time after online intervention (Baseline + 4 months))
- Quality of Life (physical health, psychological health, social relationships, and environment)(Change from Baseline QoL to the point of time after online intervention (Baseline + 4 months)])
- Treatment satisfaction according to modified version ZUF-8(Treatment satisfaction at the point of time after online intervention (4 months after admission to studies))
- Knowledge increase of the cooperating physicians on trans health care (via VSE)(Change from Baseline to the point of time after study completion (Baseline + 18 months))
- Health-related quality of life (via EQ-5D-5L): quality-adjusted life years (QALYs)(Change from Baseline to the point of time after online intervention (Baseline + 4 months))
- Satisfaction of the cooperating physicians with the support in the i2TransHealth network (via modified version ZUF-8)(Satisfaction at the point of time after study completion (18 months))
研究者
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