| CTRI Number |
CTRI/2025/10/096167 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Selected IDEAL discharge planning strategies with Mobile text reminders on Medication Adherence, Work and Social Adjustment and Relapse among Psychiatric Inpatients |
|
Scientific Title of Study
|
A study to Evaluate the Effectiveness of Selected IDEAL discharge planning strategies with Mobile text reminders on Medication Adherence, Work and Social Adjustment and Relapse among Psychiatric Inpatients at Tertiary care institution |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Syed Ruqaya Shameem |
| Designation |
MSc Nursing student |
| Affiliation |
AIIMS Mangalagiri |
| Address |
103, college of nursing
AIIMS Mangalagiri.
Guntur
Andhra Pradesh
522503
India
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7780919194 |
| Fax |
|
| Email |
syedr91299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasan P |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
103, college of Nursing,
Psychiatric Nursing
AIIMS Mangalagiri, Guntur District (A.P) 522503
Andhra Pradesh
522503
India
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7988410148 |
| Fax |
|
| Email |
vasans85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Syed Ruqaya Shameem |
| Designation |
MSc Nursing student |
| Affiliation |
AIIMS Mangalagiri |
| Address |
103, colllege of nursing
AIIMS Mangalagiri.
Guntur
Andhra Pradesh
522503
India
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7780919194 |
| Fax |
|
| Email |
syedr91299@gmail.com |
|
|
Source of Monetary or Material Support
|
| 103, College of Nursing, AIIMS Mangalagiri, Guntur(A.P)-522503 |
|
|
Primary Sponsor
|
| Name |
Ms Syed Ruqaya Shameem |
| Address |
UG Girls hostel, Room no 214,AIIMS Mangalagiri. |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Ms Syed Ruqaya Shameem |
AIIMS Mangalagiri, 103 college of nursing, psychiatric nursing |
Psychiatric nursing
103,College of Nursing, AIIMS Mangalagiri
Guntur
Andhra Pradesh
Guntur
ANDHRA PRADESH |
7780919194
syedr91299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commmittee,AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human Volunteers are the psychiatric inpatients residing in Tertiary care institution- |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Selected IDEAL Discharge Planning Strategies. |
structured intervention designed to enhance post-discharge outcomes among psychiatric inpatients, which comprises of the administration of extensive psychoeducation sessions, group activity cum interactive discussion session (5 days, 5 sessions, 1 session/day, 30 minutes/session) followed by mobile text reminders with positive affirmation (25 days) to encourage consistent medication adherence, thereby supporting work and social adjustment while reducing the risk of relapse based on the three elements i.e Discussion, Education and Listen |
| Comparator Agent |
Treatment as usual.
(No specific intervention) |
Control group will not receive any intervention, it will be treatment as usual group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 18 years and above diagnosed with schizophrenia, mood disorders and substance dependence only.
2. Psychiatric inpatients or caregivers with access to mobile phone and are able to read the text messages.
3. Willing to participate in the study
4. Alert, oriented and comprehend to response
5. Able to speak, read and understand either English or Telugu.
|
|
| ExclusionCriteria |
| Details |
1. Psychiatric inpatients who are discharged before 6 days or more than 14 days from the day of enrollment.
2. Not available during the study
3. Admitted with co-morbidities .
4. Not permitted to participate for legal or forensic reason |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Medication Adherence, Work and Social Adjustment and Relapse |
DAY 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Satisfaction regarding Selected IDEAL discharge planning strategies with Mobile text reminders in intervention group. |
Day 45 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
01/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Psychiatric illnesses are chronic in nature and often require long-term medication adherence and structured social rehabilitation. Non-adherence to medication and lack of proper discharge planning significantly increase the risk of relapse and poor work and social adjustment. This study aims to evaluate the effectiveness of selected IDEAL discharge planning strategies supported by mobile text reminders in improving medication adherence, work and social adjustment, and in preventing relapse among psychiatric inpatients.This is a non-randomized controlled trial. A total of 40 psychiatric inpatients who meet the inclusion criteria will be selected through Convenience Samplingand to prevent the contamination, control group will be completed first before proceeding with the experimental group.The study includes psychiatric inpatients diagnosed with schizophrenia, mood disorders, or substance dependence. Eligible participants must have access to a mobile phone, be able to read text messages, be alert and oriented, willing to participate, and capable of speaking, reading, and understanding either English or Telugu.Patients discharged before six days from the day of enrolment or are unavailable during the study period, have comorbid medical or psychiatric conditions, are not permitted to participate for legal or forensic reasons, or are already enrolled in other related studies will be excluded. The experimental group will receive 30-minute session each day for a period of 5 days, sessions include extensive psychoeducation on psychiatric medication and its adherence, extensive psychoeducation on work and social adjustment, extensive psychoeducation on relapse, Group activity session, and closing session, followed by mobile text reminders with positive affirmations for a period of 25 days. The control group will receive routine discharge care.Data will be collected using validated tools: Medication Adherence Rating Scale (MARS), the Work and Social Adjustment Scale (WSAS), and Clinical Records. Post test will be conducted on the 45th day for both groups. Descriptive and inferential statistics will be used for data analysis. . |