Efficacy of telemedicine consultation compared to in-person consultation for patients with major mental illness: An open-label randomised control trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 496
- Locations
- 1
- Primary Endpoint
- 1. change in CGI-S scores at all consultations to assess severity.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •• 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.
Exclusion Criteria
- •Patients with severe disease as determined by requiring inpatient care or referral to a higher centre for intervention.
Outcomes
Primary Outcomes
1. change in CGI-S scores at all consultations to assess severity.
Time Frame: Baseline, 15th, 30th, 45th day
Secondary Outcomes
- 1. Change in Positive and Negative symptoms scale (PANSS) scores for schizophrenia.(2. Change in Hamilton rating scale for depression (HAM-D) for Depression.)
Investigators
Santanu Nath
All India Institute of Medical Sciences-Deoghar