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CTRI Number  CTRI/2025/07/091782 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Teaching People with Type 2 Diabetes About Low Blood Sugar Using Videos. 
Scientific Title of Study   Effectiveness of Video-based Education in Enhancing Hypoglycemia Knowledge among Patients with Type 2 Diabetes Mellitus 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adwaith V V  
Designation  PG Student 
Affiliation  NGSM Institute of pharmaceutical sciences 
Address  Department of pharmacy practice, NGSM Institute of pharmaceutical sciences, Paneer, Derlakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7559942636  
Fax    
Email  adwaithvvcheleri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nandakumar U P  
Designation  Assistant Professor 
Affiliation  NGSM Institute of pharmaceutical sciences 
Address  Department of pharmacy practice, NGSM Institute of pharmaceutical sciences, Paneer, Derlakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9633023062  
Fax    
Email  nandakumar@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Nandakumar U P  
Designation  Assistant Professor 
Affiliation  NGSM Institute of pharmaceutical sciences 
Address  Department of pharmacy practice, NGSM Institute of pharmaceutical sciences, Paneer, Derlakatte, Mangalore


KARNATAKA
575018
India 
Phone  9633023062  
Fax    
Email  nandakumar@nitte.edu.in  
 
Source of Monetary or Material Support  
Department of pharmacy practice, NGSM Institute of pharmaceutical sciences, Paneer, Derlakatte, Mangalore, Karnataka,575018  
Justice KS Hegde Charitable Hospital, Derlakatte, Mangalore, Karnataka, 575018 
 
Primary Sponsor  
Name  NGSM Institute of pharmaceutical sciences 
Address  Department of pharmacy practice, NGSM Institute of pharmaceutical sciences, Paneer, Derlakatte, Mangalore, Karnataka, 575018 
Type of Sponsor  Other [Academic Institute] 
 
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 Shuaib Ahmed M A   Justice KS Hegde Charitable Hospital  Department of General Medicine
Dakshina Kannada
KARNATAKA 
9880322268

shuaib9800@hotmail.com 
 
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 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Patients aged above 18 years, diagnosed with Type 2 Diabetes Mellitus and undergoing treatment in the department of general medicine.
2 Patients who can read and understand either English, Kannada or Malayalam languages.
3 Patients who give their consent
 
 
ExclusionCriteria 
Details  1 Critically ill patients
2 Pregnant and lactating women
3 Individuals with psychiatric and cognitive disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This research aims to enhance patients understanding and self management of hypoglycemia in diabetes through a validated video based educational intervention.   8 months 
 
Secondary Outcome  
Outcome  TimePoints 
The findings are expected to highlight the role of innovative patient education strategies in improving therapeutic outcomes and quality of life.  8 months 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   05/08/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  


INTRODUCTION

Hypoglycemia is a common and potentially life-threatening complication in diabetic patients. Despite its significance, many patients and their caregivers have limited awareness on the symptoms, prevention strategies, and appropriate corrective actions.

OBJECTIVES OF STUDY

To develop, validate and perform user-testing of an educational video on hypoglycemia for patients undergoing treatment for diabetes mellitus and to assess the impact of video-based education on knowledge of hypoglycemia among patients undergoing treatment for diabetes mellitus.

JUSTIFICATION OF THE STUDY

Traditional patient education methods, such as pamphlets and verbal counseling, often fail to ensure adequate knowledge retention and engagement. In contrast, multimedia tools, like videos, can enhance patient education and empower individuals to approach the treatment with more confidence. However, many of the available video-based educational resources contain incomplete and misleading information. This highlights the need for well structured, evidence-based, and professionally developed video content to ensure reliable patient education.

METHODOLOGY

Patients of either gender, aged above 18 years, diagnosed with Type 2 Diabetes Mellitus and undergoing treatment in the department of general medicine and patients who can read and understand either English, Kannada or Malayalam languages will be included in the study. An educational video on hypoglycemia will be developed based on the validated content using the Capcut Application in English and translated into Kannada and Malayalam. The video will be evaluated by a multidisciplinary team using a four-point Likert scale. A multiple-choice knowledge questionnaire will be prepared, validated, and translated into local languages. Participants’ baseline knowledge and the change in their understanding after having completely viewed the video will be assessed using this questionnaire.

STATISTICAL ANALYSIS

Statistical analysis will be done using SPSS 29.0 at 95% confidence interval. Qualitative data will be presented as frequency and percentage. Quantitative data will be presented as mean ± standard deviation. Cronbach’s alpha value greater than 0.70 will be considered acceptable, on testing the questionnaire for reliability. To compare pre and post user-testing scores, paired t-test/Wilcoxon sign rank test will be used. A p value <0.05 will be considered statistically significant.

OUTCOME MEASURES

This research aims to enhance patients’ understanding and self-management of hypoglycemia in diabetes through a validated video-based educational intervention. The findings are expected to highlight the role of innovative patient education strategies in improving therapeutic outcomes and quality of life.

 
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