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CTRI Number  CTRI/2025/07/090244 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Attitude regarding medication intake among the patient admitted. 
Scientific Title of Study   Attitude towards drug adherence among patient admitted in a tertiary mental health institute. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Archana Baishya 
Designation  Msc Nursing 1st year trainee 
Affiliation  LGB Regional Institute of Mental Health 
Address  BLOCK A INDOOR, ROOM NO 22, LGBRIMH TEZPUR
Assam India
Sonitpur
ASSAM
784001
India 
Phone  7635868723  
Fax    
Email  baishyaarchana1177@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Kollipara 
Designation  Nursing Tutor 
Affiliation  LGB Regional Institute of Mental Health 
Address  department of psychiatric nursing , 3rd floor, academic block, LGBRIMH TEZPUR
Assam India
Sonitpur
ASSAM
784001
India 
Phone  7399125255  
Fax    
Email  sandeepkolliparatmu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Archana Baishya 
Designation  msc nursing 1st year trainee 
Affiliation  LGB Regional Institute of Mental Health 
Address  department of psychiatric nursing, 3rd floor, academic block, LGBRIMH TEZPUR
Assam India
Sonitpur
ASSAM
784001
India 
Phone  7635868723  
Fax    
Email  baishyaarchana1177@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  self  
Address  department of psychiatric nursing, 3rd floor, academic block, LGBRIMH,TEZPUR 
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 
Archana Baishya  LGB Regional Institute of Mental Health  indoor block A, room no 22
Sonitpur
ASSAM 		 7635868723

baishyaarchana1177@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee LGBRIMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (2) ICD-10 Condition: F30-F39||Mood [affective] disorders, (3) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  - Patient who are fit for discharge as per the decision of the treating team.
- Patient who can read and write either assamese or english language.  
 
ExclusionCriteria 
Details  - patient admitted in Dept of Child and Adolescent, Geriatric and De-addiction medicine.
- patient those discharged on DAMA(discharged against medical advice) or LAMA(leave against medical advice) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
attitude towards drug adherence   one time assessment after 4 weeks of admission  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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)   24/11/2025 
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="2"
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   Adherence to long term psychotropic medication remains a critical challenge for individual suffering from psychiatric illness.. Negative attitude towards drug adherence, influenced by societal stigma, lack of awareness, poor insight leading to worsening of symptoms, re-hospitalization, poor quality of life and wastage of healthcare resources. In contrary, positive attitude can help the patient lead a quality life preventing relapse of the symptoms. The study will shred light on the attitude of the patients towards drug adherence and understanding of the medication. Problem statement: A study to assess the Attitude towards Drug Adherence among the patient admitted in a Tertiary Mental Healthcare Institute, Northeast India. Aim and objectives: The study aims to assess the attitude of patients towards drug adherence and to determine the association between attitude and socio-demographic data. Methodology: Quantitative Approach and Descriptive Cross Sectional Research Design will be adopted in this study. The study will be conducted among the people diagnosed with mental illness and are admiited in LGBRIMH, Tezpur by using Systematic Random Sampling Technique. The sample size is  320; calculated by the Yamane Formula as per the census of 2024. The Assamese translated Drug Attitude Inventory will be used in the study to measure the patient’s attitude towards use of psychotrophic medication.  The permission was obtained from the author through email. The data will be analyzed through descriptive statistic such as frequency and percentage distribution and inferential statistics such as chi-square by using SPSS software. 
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