| CTRI Number |
CTRI/2010/091/000476 [Registered on: 16/09/2010] |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Other (Specify) [Psychoeducation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effect of psycho-educative intervention on adherence to treatment among persons with bipolar disorder |
Scientific Title of Study
Modification(s)
|
Randomized controlled trial on the effect of psychoeducative intervention on drug adherence among Bipolar Affective Disorder patients in selected hospitals of Karnataka |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
LINU SARA GEORGE |
| Designation |
PROFESSOR |
| Affiliation |
MANIPAL UNIVERSITY |
| Address |
MANIPAL COLLEGE OF NURSING
MANIPAL UNIVERSITY, MANIPAL
Same as Address 1
Udupi
KARNATAKA
576104
India |
| Phone |
0820-29-22021 |
| Fax |
|
| Email |
linu.j@manipal.edu |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
LINU SARA GEORGE |
| Designation |
PROFESSOR |
| Affiliation |
Manipal University |
| Address |
MANIPAL COLLEGE OF NURSING MANIPAL UNIVERSITY, MANIPAL
MANIPAL COLLEGE OF NURSING
MANIPAL UNIVERSITY, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
0820-29-22021 |
| Fax |
|
| Email |
linu.j@manipal.edu |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DRPSVN SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
MANIPAL UNIVERSITY |
| Address |
HOD DEPARTMENT OF PSYCHIATRY
KASTURBA HOSPITAL
MANIPAL
KASTURBA HOSPITAL
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
0820-29-22778 |
| Fax |
|
| Email |
psvn.sharma@manipal.edu |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Investigator |
| Address |
Manipal College of Nursing
Manipal University
Manipal |
| Type of Sponsor |
Other [Investigator] |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR.PSVN SHARMA |
DISTRICT HOSPITAL |
UDUPI,HOD, DEPARTMENT OF PSYCHIATRY-576101
Udupi
KARNATAKA |
0820-29-22778
psvn.sharma@manipal.edu |
| Dr PSVN Sharma |
Kasturba Hospital Manipal |
HOD DEPARTMENT OF pSYCHIATRY
KASTURBA HOSPITAL
Manipal 576104
Udupi
KARNATAKA |
0820-29-22778
psvn.sharma@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bipolar Affective Disorder, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Psycho educative intervention |
4 session,each session for 30 minutes |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Persons with bipolar affective disorder and their family caregivers who are between 20-60 years of age.
And those who could speak and understand kannada. Patients and family caregivers who could listen,comprehend and speak clearly. |
|
| ExclusionCriteria |
| Details |
Patients and family caregivers who are having chronic medical illness and those whoare on alcohol and drug dependence and organic mental disorders. |
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Adherence to treatment |
one |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Knowledge, Attitude ,Quality of life,Disability, Burden |
four |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
11/09/2008 |
| Date of Study Completion (India) |
28/01/2011 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study was a randomized clinical trial of the effect of psycho-educative intervention on adherence to treatment among persons with Bipolar afective disorder that was conducted in 2 hospitals;manipal and udupi.The primary outcome measure was adherence to treatment. The secondary outcomes are knowledge, attitude, quality of life and disability among persons with bipolar affective disorder and knowledge, attitude and burden for family caregivers. .The assessment was done at baseline,immediately after intervention,after one month and three months. Study completed in 2011. |