CTRI Number |
CTRI/2022/05/042773 [Registered on: 24/05/2022] Trial Registered Prospectively |
Last Modified On: |
25/07/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Screening Behavioral |
Study Design |
Other |
Public Title of Study
|
Improve Rational Use of Topical Corticosteroids |
Scientific Title of Study
|
Assessment and Evaluation of Rational Dispensing of Topical Corticosteroids By Community Pharmacists and Its Implications On Health Science Population |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sowmya Spoorthi |
Designation |
PhD Research scholar |
Affiliation |
KLE college of pharmacy, KAHER |
Address |
Room no: 15, Department of Pharmacy practice, KLE college of Pharmacy, KAHER, JNMC campus, Nehru nagar
Belgaum KARNATAKA 590010 India |
Phone |
8884884875 |
Fax |
|
Email |
sowmya.spoorthi27@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M S Ganachari |
Designation |
Prof & HOD |
Affiliation |
KLE college of pharmacy, KAHER |
Address |
Room no: 15
Department of Pharmacy practice
KLE college of Pharmacy
KAHER
JNMC campus
Nehru nagger Room no: 15
Department of Pharmacy practice
KLE college of Pharmacy
KAHER
JNMC campus
Nehru nagger Belgaum KARNATAKA 590010 India |
Phone |
9448634457 |
Fax |
|
Email |
msganachari@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sowmya Spoorthi |
Designation |
PhD Research scholar |
Affiliation |
KLE college of pharmacy, KAHER |
Address |
Room no: 15, Department of Pharmacy practice, KLE college of Pharmacy, KAHER, JNMC campus, Nehru nagar
Belgaum KARNATAKA 590010 India |
Phone |
8884884875 |
Fax |
|
Email |
sowmya.spoorthi27@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
KAHER |
Address |
JNMC,Nehru Nagar,Belgavi |
Type of Sponsor |
Research institution and hospital |
|
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 Sowmya Spoorthi M |
KLE Hospitals |
Room no: 23, Department of dermatology, 1st floor, KLE hospitals. Belgaum KARNATAKA |
8884884875
sowmya.spoorthi27@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KAHER ethics committee on human subjects |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L309||Dermatitis, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Clinical Pharmacist Education and Awareness on use of Topical corticosteroids. |
Community Pharmacist
Health Science Students
Patients
are recruited for 6 months and follow up for 6 months |
Comparator Agent |
Standard counseling |
Standard treatment given for 6 months |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Registered Community Pharmacist in and around Belagavi.
Health Science Student Population of KLE University.
Patients who are prescribed with topical corticosteroid.
Patients who give history of TCs use on face. |
|
ExclusionCriteria |
Details |
Health Science Students already using systemic corticosteroids.
Patients on systemic corticosteroids.
Special population like pregnant and lactating women. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Promoting rational dispensing of topical corticosteroids among community pharmacist by 1 month and 3 months followup.
Increase the awareness about topical corticosteroids among undergraduate students for pre and post 1 month and 3 months followup.
|
followup for 1 month and 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
• To improve knowledge ,attitude and perception about topical corticosteroids among patients. |
1 year |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "265"
Final Enrollment numbers achieved (India)="265" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
06/06/2022 |
Date of Study Completion (India) |
25/02/2023 |
Date of First Enrollment (Global) |
06/06/2022 |
Date of Study Completion (Global) |
25/02/2023 |
Estimated Duration of Trial
|
Years="1" Months="10" Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
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)?
Response - NO
|
Brief Summary
|
1) 1) Approval
from the ethics committee will be obtained before conducting the study.
2) KAP
questionnaire & Subject Information Leaflet (PIL) will be prepared by
referring to various primary, secondary, and tertiary sources.
3) Prepared
SIL(Subject Information Leaflet) will be validated for its content and design
using various readability statistics (Western formula) and user readability
testing.
4) User
testing questionnaires will be developed based on the content of the SILS and
will also be validated.
5) The
validated KAP questionnaires will be used to identify the Knowledge ,Attitude
and perception of Community pharmacist, Students and Patients.
6) The
Community pharmacist, Students, Patients will be enrolled in the study after
obtaining written informed consent .
7) All
the relevant information will be collected in a specially designed data
collection.
8) The
Community Pharmacist , Students and patients will be assessed for the knowledge, Attitude
and Perception level using pre-validated
tools.
9) The
enrolled Community Pharmacist after screening them and obtaining Informed
Consent they will be administering KAP
questionnaires as pre test to assess knowledge Attitude and Perception.
10) The Community Pharmacist will be requesting
to attend Webinar and educational intervention by a clinical pharmacist.
(Educational intervention includes the additional Information offered by the
Clinical Pharmacist about Topical Corticosteroid. The pharmacist will analyse
the Knowledge level from the Pre-test conducted by using KAP Questionnaires and
will provide the Pharmacist education and counselling on various aspects of Topical
Corticosteroids , including potency of topical corticosteroids and its common
side effects, need for adherence to drug therapy. The student will be provided
with the validated SIL(Subject Information Sheet), after one month followup
will be taken using same KAP Questionnaires by electronic means)
11) The
enrolled Students will be randomly assigned to the two groups viz-intervention
group (IG) and the Control group (CG).
12) The Control
group will receive Student Information Leaflet without Counselling by the Clinical Pharmacist.
13) The
intervention group will receive the Counselling by the physician via Webinar
and educational intervention by a clinical pharmacist. (Educational
intervention includes the additional care offered by the Clinical Pharmacist.
The pharmacist will analyse the Student drug therapy if any, and will provide
the Student education and counselling on various aspects of Topical
Corticosteroids , including diseases, drugs and its common side effects, need
for adherence to drug therapy, and need and measures for lifestyle
modification. The student will be provided with the validated SIL, monthly
reminder regarding the drug therapy by electronic means if any)
14) All
the enrolled students in both of the groups will be called on follow up, and
the responses on the knowledge level, Attitude, and perception about Topical Corticosteroids
of the Students will be recorded. (A total of three times KAP Questionnaire
will be administered
, i.e., baseline, after 1st month and 3rd month .
15) The
enrolled Patients after screening them and obtaining Informed Consent they will
be administering KAP questionnaires as
pre test to assess knowledge , Attitude and Perception about Topical
Corticosteroids.
|