| CTRI Number |
CTRI/2024/04/065474 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Texy messaging] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Text Messaging in first episode psychosis |
|
Scientific Title of Study
|
Effect of text message reminders on treatment retention rates among outpatients with first episode psychosis: A randomized controlled trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikas Menon |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Dept of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry- 605005
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098158528 |
| Fax |
|
| Email |
drvmemon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Menon |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) |
| Address |
Dept of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry- 605005
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098158528 |
| Fax |
|
| Email |
drvmemon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Menon |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Dept of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Puducherry- 605005
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8098158528 |
| Fax |
|
| Email |
drvmemon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Post Graduate Medical Education and Research, GORIMEDU, PONDICHERRY -605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER, GORIMEDU, PONDICHERRY -605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharmi B |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Pondicherry |
Room No 74, Dept of Psychiatry, Old Hospital Building, JIPMER, Gorimedu, Dhanvantari nagar, Puducherry - 605006
Pondicherry
PONDICHERRY |
9080612761
sharmibascarane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Interventional Studies CDSCO Reg No : ECR/342/Inst/PY/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30-F39||Mood [affective] disorders, (2) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The control group will not receive the text messages. The control group will be followed till the end of study period. |
| Intervention |
Intervention group |
The intervention consists of sending text message reminders to intervention group 3 days and 5 days prior to the next follow up visit. The expected frequency of follow up of patients is once in two to three weeks. Fixed frequency text message reminders will be sent for medication adherence on Monday and thursday of every week. The text messages will be sent for 6 months and will be continued till the end of the study period until the last patient is recruited and followed up for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18 to 40 years presenting to JIPMER with first episode of psychosis with duration of illness less than 12 months and less than four weeks of treatment with antipsychotic, antidepressant, or mood stabilizer regardless of recovery.
|
|
| ExclusionCriteria |
| Details |
1. Caregivers without access to mobile phones
2. Caregivers who cannot read Tamil or english
3. Patients with organic psychosis
4. Psychosis due to substance use
5. Refusal to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Text message reminder intervention increases the time to dropout among patients with first episode psychosis compared to treatment as usual |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Medication adherence, insight, social and occupational functioning |
Baseline,1, 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
20/04/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Eligible patients satisfying inclusion criteria will be consented for study purposes. Since this is a pilot RCT, sample size has not been calculated as it is difficult to predict the dropout rates and patients will be recruited till the end of the study period. After baseline assessment, the participants will be randomly assigned into the control and intervention groups. SMS reminders for treatment appointment and medication adherence, at a frequency described before, will be sent to the intervention group. Outcome measures such as time to drop out (primary outcome) will be assessed over the follow-up period of 6 months, along with medication adherence, functioning, and insight (secondary outcomes) at 1,3 and 6 months. For the statistical analysis, survival analysis using cox proportional hazards regression will be done with group assignment as the primary variable of interest and the following as co-variates, subject to there being at least 10 events per independent variable: 1. Distance from hospital 2. Living with parents 3. Regular employment 4. Baseline psychopathology 5. Insight 6. Substance use 7. Family emergencies 8. Education 9. Age 10. Sex |