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CTRI Number  CTRI/2024/06/069070 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [mobile phone-based text message reminders]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of adjunctive mobile phone-based text message reminders on treatment retention among inpatients with severe mental illnesses following discharge 
Scientific Title of Study   Effect of text message reminders on treatment engagement among patients with severe mental illness after discharge from inpatient settings: A randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
none  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Natarajan Varadharajan 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Psychiatry, JIPMER, Puducherry Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  9790816564  
Fax    
Email  natarajanv1158@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Natarajan Varadharajan 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Psychiatry, JIPMER, Puducherry Pondicherry PONDICHERRY 605006 India


PONDICHERRY
605006
India 
Phone  9790816564  
Fax    
Email  natarajanv1158@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Natarajan Varadharajan 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Psychiatry, JIPMER, Puducherry Pondicherry PONDICHERRY 605006 India


PONDICHERRY
605006
India 
Phone  9790816564  
Fax    
Email  natarajanv1158@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Campus Road, JIPMER Campus, Dhanvantari Nagar, Puducherry, 605006  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Natarajan Varadharajan  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Room no-74, Ground Floor, Department of Psychiatry, Old hospital building, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), JIPMER Campus, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 
9790816564

natarajanv1158@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR OBSERVATIONAL STUDIES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia, (2) ICD-10 Condition: F31||Bipolar disorder, (3) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (4) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  mobile phone-based text messages  The intervention group will receive text message reminders regarding the follow-up dates and medication adherence. 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 3 days and 5 days prior to their next follow-up visit (every 3 weeks). These messages will contain text that initially greets the recipient followed by reminders about their next follow-up date in JIPMER, ending with a thank you note and positive message (“have a nice day”). Fixed frequency text message reminders will be sent for medication adherence on Monday and Thursday of every week. These messages will contain text that initially greets the recipient followed by a generic reminder about taking their medication as prescribed and finally ending with a thank you note and positive message (“have a nice day”). Totally, there will be twice weekly messages except in one week where there will be 4 messages per week. The message will be sent in Tamil or English as per the participant’s preference. This intervention will be carried out for 12 months.  
Comparator Agent  Standard usual care   The standard treatment, which will be followed for the Schizophrenia/Bipolar disorder/ Severe depression with psychotic symptoms patients group. They will not receive the text messages and will be followed till the end of study period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Diagnosis of Schizophrenia, Bipolar disorder,
Severe depression with psychotic symptoms
admitted to inpatient department of Psychiatry,
JIPMER,Puducherry
2. At least six months of duration of illness
 
 
ExclusionCriteria 
Details  1. Patients/Caregivers without access to mobile
phones
2. Patients/Caregivers who cannot read
Tamil/English
3. Patients with organic psychosis
4. Psychosis due to substance use
5. Refusal to give informed consent
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to drop out (i.e treatment engagement) is the primary outcome over the study period of 12 months  1 week, 3rd week, 5th week, 3rd month onwards monthly till the 12th month (study end point)
 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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