CTRI Number |
CTRI/2018/05/014159 [Registered on: 29/05/2018] Trial Registered Retrospectively |
Last Modified On: |
16/05/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Drug usage in geriatric patients visiting medicine outpatient department |
Scientific Title of Study
|
“Drug utilization study in geriatric patients of
medicine out-patient departmentâ€
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Pradeep G Jadhav |
Designation |
Junior Resident |
Affiliation |
Government Medical College,Miraj |
Address |
Department Of Pharmacology,Pandharpur Road Government Medical College,Miraj.
Sangli MAHARASHTRA 416410 India |
Phone |
9764549422 |
Fax |
|
Email |
dr.jadhavpg15@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sunita J Ramanand |
Designation |
Professor and Head |
Affiliation |
Government Medical College,Miraj |
Address |
Department Of Pharmacology,Pandharpur Road Government Medical College,Miraj.
Sangli MAHARASHTRA 416410 India |
Phone |
7218664433 |
Fax |
|
Email |
sjramanand@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sunita J Ramanand |
Designation |
Professor and Head |
Affiliation |
Government Medical College,Miraj |
Address |
Department Of Pharmacology,Pandharpur Road Government Medical College,Miraj.
Sangli MAHARASHTRA 416410 India |
Phone |
7218664433 |
Fax |
|
Email |
sjramanand@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Pradeep G Jadhav |
Address |
Department of Pharmacology, Government Medical College, Miraj, Pandharpur Road, Miraj |
Type of Sponsor |
Other [Self] |
|
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 |
Pradeep G Jadhav |
Government Medical College and Hospital Miraj |
OPD No 8, Medicine outpatient department,Government Medical College,Miraj, Pandharpur Road, Miraj. Sangli MAHARASHTRA |
9764549422
dr.jadhavpg15@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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Geriatric patients visiting Medicine outpatient department, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
60.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
Prescription data of all patients above age 60yrs of medicine out-patient department . |
|
ExclusionCriteria |
Details |
Patients below age 60yrs |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Drug utilization pattern using WHO core indicators in geriatric patients of medicine outpatient department |
Six months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Identification of the commonly used class of drugs in the above patients. |
Six months |
Exposure rates of different class of drugs in the geriatric patients.
|
Six months |
Comparison of the results of drug utilization with Beer’s criteria |
Six months |
|
Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
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)
|
01/01/2018 |
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) |
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
|
Background:Geriatrics is a branch of medicine dealing with the
physiologic characteristics of aging and the diagnosis and treatment of
diseases affecting the aged.
In most of the countries in the world
including India cut-off point for geriatric age is 60 yrs. Recent increase in the proportion and number of elderly in many developing countries have drawn attention
to issues concerning the morbidity profile of this potentially vulnerable age group. As per the 1991 census the elderly population in
India was 57 million as compared with 20 million in 1951.As per 2011 census there
are nearly 104 million elderly persons; 53 million female and 51 million males.
It has been projected that by the year 2050, the number of elderly people would rise to about 324
million. More than half of the geriatric people are suffering from any sort of
physical morbidity. The 2012
American Geriatrics Society Beers Criteria, they include lists of potentially
inappropriate medications to be avoided in older adults. New to the criteria
are lists of select drugs that should be avoided or have their dose adjusted
based on the individual’s kidney function and select drug–drug interactions
documented to be associated with harm in older adults. The specific aim was to
have a 13-member interdisciplinary panel of experts in geriatric care and
pharmacotherapy update the 2012 AGS Beers Criteria using a modified Delphi
method to systematically review and grade the evidence and reach a consensus on
each existing and new criterion. The process followed an evidence-based
approach using Institute of Medicine standards. The 2015 AGS Beers Criteria are
applicable to all older adults with the exclusion of those in palliative and
hospital care. The intentions of the criteria include: 1) Improving the selection of prescription drugs by
clinicians and patients; 2) Evaluating patterns of drug use within
populations; 3) Educating clinicians and patients on proper drug
usage; and 4) Evaluating health-outcome, quality of care,
cost, and utilization data. Purpose of the study: The
present study intends to study drug utilization pattern in geriatric patients
of medicine outpatient department using WHO core indicators & study
exposure rates & compare with Beer’s criteria.
|