跳至主要内容
临床试验/CTRI/2025/07/090684
CTRI/2025/07/090684
招募中
不适用

Efficacy of telemedicine consultation compared to in-person consultation for patients with major mental illness: An open-label randomised control trial

Multidisciplinary Research Unit MRU of AIIMS Deoghar under DHR1 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2025年7月21日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Multidisciplinary Research Unit MRU of AIIMS Deoghar under DHR
入组人数
496
试验地点
1
主要终点
1. change in CGI-S scores at all consultations to assess severity.

概览

简要总结

Despite the wide use of telemedicine across India, the efficacy of telemedicine over in-person consultations has yet to be established for mental health. This is one of the barriers to the broader utilisation and expansion of the services from the patient’s and clinicians’ points of view. We could not find similar studies in the Indian context. Paper to public health translation of telemedicine guidelines requires evidence for its usefulness across contexts, disorders, and demographics. The current study will help generate evidence for the feasibility of telemedicine compared to in-person consultations for patients with severe mental illnesses like schizophrenia, bipolar disorder, OCD and depression. The hypothesis for this trial is that, the efficacy of telemedicine will be equal to an in-person consultation for severe mental illness, and telemedicine will be cost-effective compared to in-person consultations for the same purpose.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • • Adult patients diagnosed with major mental illness like Schizophrenia Bipolar Disorder Major Depressive Disorder and OCD were diagnosed using ICD
  • • Able to provide written informed consent.
  • • Having Mobile phone with WhatsApp facility.

排除标准

  • Patients with severe disease as determined by requiring inpatient care or referral to a higher centre for intervention.

结局指标

主要结局

1. change in CGI-S scores at all consultations to assess severity.

时间窗: Baseline, 15th, 30th, 45th day

次要结局

  • 1. Change in Positive and Negative symptoms scale (PANSS) scores for schizophrenia.(2. Change in Hamilton rating scale for depression (HAM-D) for Depression.)

研究者

发起方
Multidisciplinary Research Unit MRU of AIIMS Deoghar under DHR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Santanu Nath

All India Institute of Medical Sciences-Deoghar

研究点 (1)

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