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跨性别者跨学科互联网医疗(i²TransHealth):一项随机对照试验的研究方案。

Interdisciplinary, internet-based trans health care (i²TransHealth): study protocol for a randomised controlled trial.

机构信息

Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Interdisciplinary Transgender Health Care Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Interdisciplinary Transgender Health Care Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

出版信息

BMJ Open. 2022 Feb 1;12(2):e045980. doi: 10.1136/bmjopen-2020-045980.

Abstract

INTRODUCTION

Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants' place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers' perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network?

METHODS AND ANALYSIS

In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth.

ETHICS AND DISSEMINATION

Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications.

TRIAL REGISTRATION NUMBER

NCT04290286.

PROTOCOL VERSION

22 December 2021 (V.1.0).

摘要

简介

生活在缺乏跨性别者健康护理结构的地区对跨性别者不利。通过提供基于互联网的医疗保健计划,i²TransHealth 旨在减少生活在缺乏专业护理地区的跨性别者面临的结构性劣势。该电子健康干预措施包括视频咨询和与研究治疗师的一对一聊天。此外,i²TransHealth 网络与医生合作,医生专门在参与者居住地附近提供危机干预。本研究的目的是评估基于互联网的跨性别者健康护理计划与对照组(等待)相比的(成本)效益。将对 163 名跨性别者进行以下研究问题的研究:接受 i²TransHealth 基于互联网的健康护理计划 4 个月的治疗是否能改善患者报告的健康结果?从社会或医疗保健支付者的角度来看,i²TransHealth 是否具有成本效益?参与和接受 i²TransHealth 的支持是否会导致医生网络中跨性别相关专业知识的增加?

方法和分析

在一项随机对照试验中,将研究一项针对跨性别者的基于互联网的健康护理计划的结果。在干预组中,邀请参与者使用 i²TransHealth 4 个月。分配到对照组的参与者将能够在参加研究 4 个月后开始进行他们的性别过渡相关护理。主要结果测量指标是使用 i²TransHealth 计划 4 个月后,通过 Brief Symptom Inventory-18 评估的躯体症状减少。两组参与者都将在基线和使用 i²TransHealth 4 个月后进行评估。

伦理和传播

汉堡医疗协会(PV7131)已批准该研究符合伦理要求。结果将通过媒体向服务使用者及其家属传播,通过专业培训和会议向医疗保健专业人员传播,并通过会议和出版物向研究人员传播。

试验注册号

NCT04290286。

方案版本

2021 年 12 月 22 日(V.1.0)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/00c3/8808412/17136ec16b46/bmjopen-2020-045980f01.jpg

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