CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2024/12/078740 [Registered on: 30/12/2024] Trial Registered Prospectively

Last Modified On:

28/12/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

quasi-experimental

Study Design

Single Arm Study

Public Title of Study

Development of a video on insulin administration for educating diabetes mellitus patients

Scientific Title of Study

Development, validation and user testing of video-based educational support on insulin administration for diabetes mellitus patients

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Vineeth Mascarenhas
Designation	Pharm D Student
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, (Nitte Deemed to be University), Deralaktte, Mangaluru Dakshina Kannada Karnataka 575018 India Dakshina Kannada KARNATAKA 575018 India
Phone	9108596852
Fax
Email	vineethm2001@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Praneetha Jain
Designation	Assistant Professor
Affiliation	NGSM Institute of Pharmaceutical Sciences
Address	Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru Dakshina Kannada KARNATAKA 575018 India
Phone	8431480836
Fax
Email	praneetha.jain@nitte.edu.in

Details of Contact Person
Public Query

Name	Dr Pratheeksha Rai G
Designation	Associate Professor
Affiliation	Justice K S Hegde Charitable Hospital
Address	Department of General Medicine, Justice K S Hegde Charitable Hospital, Mangaluru Dakshina Kannada KARNATAKA 575018 India
Phone	9945609818
Fax
Email	pratty.pr@nitte.edu.in

Source of Monetary or Material Support

Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru-575018 India

Primary Sponsor

Name	NIL
Address	NIL
Type of Sponsor	Other [NIL]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Praneetha Jain	Justice K S Hegde Charitable Hospital	Department of General Medicine, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru-575018 Dakshina Kannada KARNATAKA	8431480836 praneetha.jain@nitte.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E119\|\|Type 2 diabetes mellitus without complications,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients aged above 18 years, newly diagnosed with Diabetes Mellitus and prescribed insulin therapy. Patients who can understand English, Kannada, or Malayalam languages.

ExclusionCriteria

Details

Patients who are critically ill.
Patients who administer insulin with the pen.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Development of video-based educational support on insulin administration for diabetes mellitus patients	single-point

Secondary Outcome

Outcome	TimePoints
The study is expected to convey the relevance of using video to educate the patients on insulin administration	single-point

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
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)

10/01/2025

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

Diabetes mellitus encompasses a group of metabolic disorders characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action or both. Patient education is pivotal in enabling individuals with diabetes to accurately self-administer insulin, monitor blood glucose levels, and manage their condition effectively. Video-based learning leverages auditory and visual elements to deliver a consistent and comprehensive educational experience. This will offer valuable insights into optimizing patient education and improving diabetes self-management practices.

OBJECTIVES:

1. To develop a patient education video on insulin administration and perform its validation and translation.

2. To perform user testing of the video.

METHODOLOGY:

It is a Quasi- experimental pre-test and post-test study without the control group that follows the convenience sampling method, conducted in the Department of General Medicine, Justice K S Hegde Charitable Hospital, Deralakatte, Mangaluru. The study will be conducted for a duration of six months from September 2024 to February 2025 on a sample size of 60 newly diagnosed patients with Diabetes mellitus who are above 18 years of age and prescribed insulin therapy and who have given their consent for the study. The confidentiality of the participants will be assured. Audio-visual aids will be prepared in English, Kannada and Malayalam languages.