| CTRI Number |
CTRI/2024/10/074737 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Frequency of non-compliance to medications and depression in the patients who are on five or more medicines |
|
Scientific Title of Study
|
Prevalence of non-adherence to medications and depression in patients with polypharmacy a cross-sectional 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 |
Dr Susmita Patwary |
| Designation |
Post graduate trainee in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831138264 |
| Fax |
|
| Email |
patwary.susmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Lopamudra Dhar Chowdhury |
| Designation |
Professor and Head in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9433135767 |
| Fax |
|
| Email |
drlopamudra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susmita Patwary |
| Designation |
Post graduate trainee in Department of Pharmacology |
| Affiliation |
R. G. Kar Medical College and Hospital |
| Address |
Department of Pharmacology, R. G. Kar Medical College and
Hospital, 1, Khudiram Bose Sarani, Kolkata-700004.
Kolkata
WEST BENGAL
700004
India |
| Phone |
9831138264 |
| Fax |
|
| Email |
patwary.susmita@gmail.com |
|
|
Source of Monetary or Material Support
|
| R. G. Kar Medical College and Hospital, Kolkata. |
|
|
Primary Sponsor
|
| Name |
R.G. Kar Medical College and Hospital |
| Address |
1, Khudiram Bose Sarani, Kolkata-700004. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Susmita Patwary |
R. G. Kar Medical College and Hospital, Kolkata. |
Medicine OPD(Room no 201), Psychiatry OPD(Room no 404) and Clinical Pharmacology OPD(Room no 209) of OPD building
Kolkata
WEST BENGAL |
9831138264
patwary.susmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, R. G. Kar Medical College and Hospital, Kolkata-700004 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (5) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (6) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
88.00 Year(s) |
| Gender |
Both |
| Details |
All the patients who are on 5 or more medicines for atleast 1 month and attending atleast 1 of the Medicine OPD, Psychiatry OPD or Clinical Pharmacology OPD.
|
|
| ExclusionCriteria |
| Details |
1) Patients attending the mentioned OPDs but who are on less than 5 medicines.
2) Patients attending the mentioned OPDs who are on 5 or more medicines but not yet completed 1month of the treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Score of Adherence by MAQ and Depression by HAM-D |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of adherence & depression |
6 months |
|
|
Target Sample Size
|
Total Sample Size="217"
Sample Size from India="217"
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)
|
21/10/2024 |
| 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="0"
Months="6"
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
|
This is a questionnaire based cross-sectional study. This study will be conducted in Medicine OPD, Psychiatry OPD and Clinical Pharmacology OPD for 6 months. The patients attending the aforesaid OPDs of R.G. Kar Medical College and Hospital, Kolkata who have received 5 or more medications for atleast 1month, will be randomly selected and then interviewed as per the standard questionnaire for medication adherence using Medication Adherence Questionnaire (MAQ) and for depression using Hamilton Depression Rating Scale(HAM-D).Finally, the prevalence of non-adherence to medications and prevalence of depression would be calculated and analysed for these polypharmacy patients. |