| CTRI Number |
CTRI/2019/07/020438 [Registered on: 30/07/2019] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To check for any Inappropriate combination of multiple medications taken by the elderly population admitted in the Medicine, Psychiatry and Oncology departments |
|
Scientific Title of Study
|
Critical and Clinical evaluation of Potentially Inappropriate Medications use in geriatric patients admitted to Medicine, Psychiatry and Oncology departments-A cohort observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| - |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amberkar Mohanbabu |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacology, Kasturba Medical College, Manipal |
| Address |
Department of Pharmacology,
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148844558 |
| Fax |
|
| Email |
drmohan7amberkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amberkar Mohanbabu |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacology, Kasturba Medical College, Manipal |
| Address |
Department of Pharmacology,
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148844558 |
| Fax |
|
| Email |
drmohan7amberkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amberkar Mohanbabu |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacology, Kasturba Medical College, Manipal |
| Address |
Department of Pharmacology,
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9148844558 |
| Fax |
|
| Email |
drmohan7amberkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amberkar Mohanbabu |
| Address |
Department of Pharmacology, Kasturba Medical College, Manipal |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 |
| Sutanka Sujaini |
Kasturba Hospital, Manipal |
Department of Medicine(Unit 1 and 3), Phychiatry and Oncology, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA |
9148844558
sutanka.sujaini@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethics Committee, Kasturba Medical College, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Includes the geriatric population |
|
| ExclusionCriteria |
| Details |
Patients below 60 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interaction patterns and frequency of inappropriate combinations |
Collection of Data over 2 months.
Study of Interaction patterns over the next month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Benefits include enhancement of impact of medicines thereby reducing problems related to dosage of medications. |
After collection of data, checking of drug interaction patterns. If inappropriate combinations found, follow up with specific department. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
18/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/08/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Multimorbidity leads to use of multiple drugs, a condition known as polypharmacy. A simple definition of polypharmacy would be the administration of more medicines than are clinically indicated. In some studies, authors have defined the concomitant ingestion of four or more as Polypharmacy while some other studies mentioned the use of five and more medications as polypharmacy. The chances of unintended adverse drug reactions due to drug-drug interactions are greater in geriatric patients because an assortment of different drugs may be administered to a patient depending on the disease or symptoms. The majority of patients admitted in department of medicine are between age group 65-75 years. In admitted elderly patients mean number of drugs prescribed was increased as age of patients increased but this was not true for discharged patients in which older elderly patients received less number of drugs. Polypharmacy is unavoidable as elderly patients usually suffer from many chronic diseases which demand use of multiple drugs resulting in complex regimen. Multiple physicians treating one patient, increasing comorbidities, and an increase in the variety of drugs available contribute to the adverse effects of polypharmacy on the elderly patient. Application of Beers criteria, appropriate therapeutic drug monitoring , and careful, periodic review of the patients medication list will assist with preventing the sometimes lethal complications of polypharmacy. Polypharmacy has somewhat variably been incorporated into geriatric assessment studies in geriatric oncology, and polypharmacy has not been consistently evaluated as a predictor of negative outcomes in patients with cancer. There is a great need to create standardized interventions to improve polypharmacy in geriatrics, and particularly in geriatric oncology. The process of deprescribing is aimed at reducing medications for which real or potential harm outweighs benefit. |