| 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
|
|
|
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
|
|
|
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. |