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CTRI Number  CTRI/2015/12/006410 [Registered on: 03/12/2015] Trial Registered Retrospectively
Last Modified On: 01/12/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Structured Educational Programme]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Educational Programme to improve the knowledge about lithium therapy among patients with bipolar disorder 
Scientific Title of Study   A Structured Educational Programme to improve the knowledge about lithium therapy among patients with bipolar disorder – A randomized control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R Shree Aarthi 
Designation  Post graduate 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Department of Psychiatry, PSG Institute of Medical Sciences and Research, P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India
Department of Psychiatry, PSG Institute of Medical Sciences and Research, P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India 641004
Coimbatore
TAMIL NADU
641 004
India 
Phone  9791304815  
Fax  04222594400  
Email  dr.shreeaarthi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  G Raghuthaman 
Designation  Head of department 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Department of Psychiatry, PSG Institute of Medical Sciences and Research, P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India
Department of Psychiatry, PSG Institute of Medical Sciences and Research, P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India 641004
Coimbatore
TAMIL NADU
641 004
India 
Phone  9789459987  
Fax  04222594400  
Email  raghuthaman_gopal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  R Shree Aarthi 
Designation  Post graduate 
Affiliation  PSG Institute of Medical Sciences and Research 
Address  Department of Psychiatry, PSG Institute of Medical Sciences and Research, P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India
Department of Psychiatry, PSG Institute of Medical Sciences and Research, P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India 641004
Coimbatore
TAMIL NADU
641 004
India 
Phone  9791304815  
Fax  04222594400  
Email  dr.shreeaarthi@gmail.com  
 
Source of Monetary or Material Support  
PSG IMSR, Peelamedu, Coimbatore, TAMIL NADU 641004 India  
 
Primary Sponsor  
Name  PSG Institute of Medical Sciences and Research 
Address  Department of Psychiatry, PSG IMSR, Peelamedu, Coimbatore, TAMIL NADU 641004 India  
Type of Sponsor  Private medical college 
 
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 
Shree Aarthi  PSG Institute of Medical Sciences and Research  P.O Box no 1664, Avinashi Road, Peelamedu, Coimbatore, Tamil Nadu, India 641 004
Coimbatore
TAMIL NADU 		 9791304815
04222594400
dr.shreeaarthi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Bipolar Affective disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Structured Educational Programme   20 min video programme educating about lithium therapy  
Comparator Agent  Treatment as usual  20 min video programme about bipolar illness in general (without educating about lithium) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with bipolar disorder who receive inpatient treatment with lithium and their relatives 
 
ExclusionCriteria 
Details  1.Patients who have co-morbid substance dependence syndrome other than tobacco use are excluded.
2.Patients who are unable to come for follow-up assessment because of long distance are also excluded from our study.
3.Patients who are on other mood stabilizers (sodium valproate, carbamazepine)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in knowledge about lithium among patients and their family members after educational video which is assessed using Lithium Knowledge Test   at baseline, 2nd month,4th month , 12th month and 24th month. 
 
Secondary Outcome  
Outcome  TimePoints 
compliance with treatment  2nd month,4th month , 12th month and 24th month. 
Quantify the lithium monitoring frequency  2nd month,4th month , 12th month and 24th month. 
Recurrence of a new episode and hospitalization  2nd month,4th month , 12th month and 24th month. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/05/2015 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A Structured Educational Programme to improve the knowledge about lithium therapy among patients with bipolar disorder – A randomized control study


Objectives

1.     To assess the knowledge about  lithium in relatives and patients with  bipolar disorder before and after education programme

2.     To assess whether this education programme could decrease lithium toxicity , improve compliance and follow up

 

Methodology

 After getting informed consent from patients as well as their key care giver we would randomize consenting patients into 2 groups, using computer generated randomization procedure: 

1) Structured Educational Programme (SEP) and 2) Treatment As Usual (TAU).

 

 Structured Educational Programme (SEP):

        We would develop an educational video for 20 minutes that is aimed to impart knowledge about bipolar disorder, prophylaxis treatments and lithium therapy.

Families of patients in this group would be shown the educational video and would be provided any clarifications sought about the illness and treatments. After a months, when the patient has reached euthymic state, the same would be replicated including the patients. This video would be repeated once in 4 months for the next 3 years.

These patients also would be seeing their primary psychiatric clinicians as scheduled by them for monitoring their mental state, medications and investigations that includes lithium levels, thyroid tests and kidney functions tests. 

 

Treatment As Usual (TAU):

For patients belonging to this group we would develop an educational video for 20 minutes that is aimed to impart knowledge about only bipolar disorder. This video does not include information regarding prophylaxis treatments and lithium therapy.

These patients also would be seeing their primary psychiatric clinicians as scheduled.

The Primary outcome and secondary outcomes are measured at baseline, 2nd  month,4th month , 12th month and 24th month.

 
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