| CTRI Number |
CTRI/2024/01/062161 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Things that affect medication taking patterns in bipolar disorder patients in a tertiary care hospital in West Bengal |
|
Scientific Title of Study
|
Factors affecting medication adherence in bipolar disorder in a tertiary care hospital: a cross-sectional observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadeem Chowdhury |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Department of Pharmacology,244 AJC Bose Road, Kolkata 244 AJC Bose Road, Kolkata-20 Kolkata WEST BENGAL 700020 India |
| Phone |
9800399253 |
| Fax |
|
| Email |
tungsten786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gairik Sengupta |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Deptartment of Pharmacology
Institute of postgraduate medical education and research
244 AJC BOSE ROAD
Kolkata WEST BENGAL 700020 India |
| Phone |
9874621539 |
| Fax |
|
| Email |
drgairiksengupta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nadeem Chowdhury |
| Designation |
Post graduate trainee |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Department of Pharmacology
244 AJC Bose Road, Kolkata 244 AJC Bose Road, Kolkata-20 Kolkata WEST BENGAL 700020 India |
| Phone |
9800399253 |
| Fax |
|
| Email |
tungsten786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Institute of Postgraduate Medical Education and Research |
| Address |
244 AJC Bose Road, Kolkata-20 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nadeem Chowdhury |
Institute of Postgraduate Medical Education and Research |
Institute of Postgraduate Medical Education and Research, Department of Pharmacology, 244 AJC Bose Road Kolkata-20 Kolkata WEST BENGAL |
9800399253
tungsten786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F317||Bipolar disorder, currently in remission, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed bipolar disorder patients as per ICD-10 criteria and under stable prescribed dose of medicines for the last 6 months and in clinical remission at the time of assessment |
|
| ExclusionCriteria |
| Details |
Any acute illness likely to influence medication adherence
Patients in acute manic or depressed phase
Patients with other significant comorbidities including substance abuse except caffeine and nicotine |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the proportion of bipolar disorder patients adherent to their prescribed medication
To assess the factors influencing adherence to medication among these patients
|
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the attitudes of bipolar disorder patients about psychiatric medications
To assess the quality of life among bipolar disorder patients
To assess the need of counselling among these patients |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
04/02/2024 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
OBJECTIVES OF PROPOSED RESEARCH: Primary objective: · To assess the proportion of bipolar disorder patients adherent to their prescribed medication · To assess the factors influencing adherence to medication among these patients Secondary objective: · To assess the attitudes of bipolar disorder patients about psychiatric medications · To assess the quality of life among these patients · To assess the need of counselling among these patients BACKGROUND OF THE STUDY: Non-adherence in patients with bipolar disorder results in aggravation, bipolar disorder recurrence, emergency room visits, hospitalization, and poor psychosocial outcomes . Though non-adherence rates have been reported to range between 30-50% in patients with bipolar disorder , the problem of adherence is often either overlooked by the physician or denied by the patient. An essential first step to enhancing medication adherence is to objectively estimate adherence. METHODOLOGY: Bipolar disorder patients (diagnosed by ICD-10 criteria) under stable prescribed dose of medicines for 6 months and in clinical remission from the outpatient department will be recruited as per selection criteria. Patients will be assessed using the following scales: - Morisky Medication Adherence Scale (MMAS)-8
- Young Mania Rating Scale (YMRS)
- WHO Quality of Life – BREF
- Drug Attitudes Inventory (DAI)-10
EXPECTED OUTCOME: Possible factors behind poor adherence identified in the study may assist in better understanding of patient behaviour regarding medication intake and suggest ways to improve therapeutic outcome in the long run.
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