Improve Rational Use of Topical Corticosteroids

Completed

• Conditions: Dermatitis, unspecified,

• Registration Number: CTRI/2022/05/042773
• Lead Sponsor: KAHER

Brief Summary

1)

1)     Approvalfrom the ethics committee will be obtained before conducting the study.

2)      KAPquestionnaire & Subject Information Leaflet (PIL) will be prepared byreferring to various primary, secondary, and tertiary sources.

3)      PreparedSIL(Subject Information Leaflet) will be validated for its content and designusing various readability statistics (Western formula) and user readabilitytesting.

4)      Usertesting questionnaires will be developed based on the content of the SILS andwill also be validated.

5)      Thevalidated KAP questionnaires will be used to identify the Knowledge ,Attitudeand perception of Community pharmacist, Students and Patients.

6)      TheCommunity pharmacist, Students, Patients will be enrolled in the study afterobtaining written informed consent .

7)      Allthe relevant information will be collected in a specially designed datacollection.

8)      TheCommunity Pharmacist , Students and patients  will be assessed for the knowledge, Attitudeand Perception level  using pre-validatedtools.

9)      Theenrolled Community Pharmacist after screening them and obtaining InformedConsent they will be administering  KAPquestionnaires as pre test to assess knowledge Attitude and Perception.

10)    The Community Pharmacist will be requestingto attend Webinar and educational intervention by a clinical pharmacist.(Educational intervention includes the additional Information offered by theClinical Pharmacist about Topical Corticosteroid. The pharmacist will analysethe Knowledge level from the Pre-test conducted by using KAP Questionnaires andwill provide the Pharmacist education and counselling on various aspects of TopicalCorticosteroids , including potency of topical corticosteroids and its commonside effects, need for adherence to drug therapy. The student will be providedwith the validated SIL(Subject Information Sheet), after one month followupwill be taken using same KAP Questionnaires by electronic means)

11)  Theenrolled Students will be randomly assigned to the two groups viz-interventiongroup (IG) and the Control group (CG).

12)  The Controlgroup will receive Student Information Leaflet without Counselling  by the Clinical Pharmacist.

13)  Theintervention group will receive the Counselling by the physician via Webinarand educational intervention by a clinical pharmacist. (Educationalintervention includes the additional care offered by the Clinical Pharmacist.The pharmacist will analyse the Student drug therapy if any, and will providethe Student education and counselling on various aspects of TopicalCorticosteroids , including diseases, drugs and its common side effects, needfor adherence to drug therapy, and need and measures for lifestylemodification. The student will be provided with the validated SIL, monthlyreminder regarding the drug therapy by electronic means if any)

14)  Allthe enrolled students in both of the groups will be called on follow up, andthe responses on the knowledge level, Attitude, and perception about Topical Corticosteroidsof the Students will be recorded. (A total of three times KAP Questionnairewill be administered , i.e., baseline, after 1st month  and 3rd month .

15)  Theenrolled Patients after screening them and obtaining Informed Consent they willbe administering  KAP questionnaires aspre test to assess knowledge , Attitude and Perception about TopicalCorticosteroids.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-06
• Study Completion: 2023-02-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• Health Science Students already using systemic corticosteroids.
• Patients on systemic corticosteroids.
• Special population like pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Promoting rational dispensing of topical corticosteroids among community pharmacist by 1 month and 3 months followup.	followup for 1 month and 3 months
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 Measures

Name	Time	Method
•To improve knowledge ,attitude and perception about topical corticosteroids among patients.	1 year

Trial Locations

Locations (1)

KLE Hospitals; 🇮🇳 Belgaum, KARNATAKA, India

KLE Hospitals

🇮🇳Belgaum, KARNATAKA, India

Dr Sowmya Spoorthi M

Principal investigator

8884884875

sowmya.spoorthi27@gmail.com