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Clinical Trials/CTRI/2024/06/069070
CTRI/2024/06/069070
Not yet recruiting
Not Applicable

Effect of text message reminders on treatment engagement among patients with severe mental illness after discharge from inpatient settings: A randomised controlled trial

JIPMER1 site in 1 country340 target enrollmentStarted: July 31, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
JIPMER
Enrollment
340
Locations
1
Primary Endpoint
Time to drop out (i.e treatment engagement) is the primary outcome over the study period of 12 months

Overview

Brief Summary

This randomized controlled trial tries to find out the effect of mobile phone-based text message reminders on time to drop out from treatment among patients with severe mental illnesses after discharge from an inpatient setting across a follow-up period of 12 months from discharge. The patients will be randomly divided into two groups (intervention and standard care groups). The intervention group will receive two sets of text message reminders on their mobile phones. One set will be variable one, where they will receive a text message on the phone three days and five days before their next follow-up visit (every four weeks). The second set of fixed-frequency text message reminders will be sent for medication adherence on Monday and Thursday of every week. There will be twice weekly messages except in one week, with four messages per week. The control group will get the usual treatment during the study period (12 months) without any intervention. Both groups of patients will be assessed for time to drop out across a 12-month follow-up period and for change in medication adherence, insight and functioning at baseline, at eight weeks, six months.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Diagnosis of Schizophrenia, Bipolar disorder, Severe depression with psychotic symptoms admitted to inpatient department of Psychiatry, JIPMER,Puducherry
  • At least six months of duration of illness.

Exclusion Criteria

  • Patients/Caregivers without access to mobile phones
  • Patients/Caregivers who cannot read Tamil/English
  • Patients with organic psychosis
  • Psychosis due to substance use 5.

Outcomes

Primary Outcomes

Time to drop out (i.e treatment engagement) is the primary outcome over the study period of 12 months

Time Frame: 1 week, 3rd week, 5th week, 3rd month onwards monthly till the 12th month (study end point)

Secondary Outcomes

  • Six-month trends in medication adherence, insight, and functioning among inpatients with severe mental illnesses after discharge from inpatient setting in intervention versus control group(The patient will be assessed at baseline, eight weeks and six months)

Investigators

Sponsor
JIPMER
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Natarajan Varadharajan

JIPMER

Study Sites (1)

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