| 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
|
|
|
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
|
|
|
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
|
|
|
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 dayâ€). 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 dayâ€). 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. |