| CTRI Number |
CTRI/2025/07/091746 [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 |
Other |
|
Public Title of Study
|
Understanding Heart Health: A Study on Diabetes Patients and Their Risk of Heart Disease |
|
Scientific Title of Study
|
Assessment of Cardiovascular Risk Factor Among Diabetic Population using validated Heart Disease Fact Questionnaire |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi C Salian |
| Designation |
PG student |
| Affiliation |
NGSM Institute of pharmaceutical sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of pharmaceutical sciences paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9036838810 |
| Fax |
|
| Email |
sakshicsalian11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of pharmaceutical sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of pharmaceutical sciences paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Barma Naga Raju |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of pharmaceutical sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of pharmaceutical sciences paneer, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9949617946 |
| Fax |
|
| Email |
barmanagaraju08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacy Practice NGSM Institute of pharmaceutical sciences, (Nitte Deemed to be University) paneer, Deralakatte, Mangaluru, Karnataka 575018 |
| Justice KS Hegde Charitable Hospital, Deralakatte, Mangaluru, Karnataka 575018 |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of pharmaceutical sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of pharmaceutical sciences, (Nitte Deemed to be University) paneer, Deralakatte, Mangaluru, 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 |
| DrChethan Subramanya |
Justice KS Hegde Charitable Hospital |
Department of General Medicine
Dakshina Kannada
KARNATAKA |
8762552454
chethansub@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified 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 willing to give consent
2.Patient of 18 years and above
3.Diagnosed with type 2 diabetes with or without comorbidities
|
|
| ExclusionCriteria |
| Details |
1.Patient with severe illness who can’t communicate properly
2.Psychiatric, cognitive, and terminal illness patients
3.Pregnant and lactating women
4.Patients with type 1 diabetes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •This study will give insights on risk factors knowledge levels about heart disease of the diabetes patients. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study also will provide the information on factors associated with knowledge levels about the heart disease among the diabetes patients. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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 Diabetes is a metabolic disorder marked by high blood sugar due to insulin issues, causing long-term damage to organs like eyes, kidneys, nerves, and the heart. Both Type 1 (autoimmune) and Type 2 (insulin resistance) diabetes increase the risk of serious complications, especially cardiovascular diseases (CVD) like heart failure and hardened arteries, driven by shared genetic and lifestyle factors. With over 830 million people globally affected, preventing and managing CVD is a critical goal in diabetes care. Given the lack of specific tools in India, this study aims to translate, validate, and assess the reliability of the Heart Disease Fact Questionnaire and evaluate T2DM patients’ knowledge about CVD risk factors.
Need for the study The rising
global prevalence of DM and its strong link to CVD highlight the urgent need
for effective health education and awareness of risk factors among diabetic
patients. A lack of knowledge can lead to poor health management and increased
cardiovascular events. Therefore, assessing diabetic patients’ understanding of
heart disease risk factors is crucial for identifying educational needs and
developing targeted health promotion strategies. The HDFQ is a valuable tool
for this assessment of the knowledge about the CVD risk factors among DM
patients. The results will not only reveal current awareness levels but
also guide healthcare providers in addressing specific educational gaps.
Objectives of the study · To translate, validate, and
assess the reliability of the Heart Disease Fact
Questionnaire for patients with diabetes mellitus.
· To assess the knowledge
regarding cardiovascular risk factors using Heart Disease Fact Questionnaire
among the diabetes mellitus patients.
Methodology The study is designed as an observational cross-sectional study to be conducted at the Department of General Medicine, Justice K S Hedge Charitable Hospital in Deralakatte, Mangaluru. A sample size of 207 diabetic patients, aged 18 and above, will be recruited using convenience sampling. Inclusion criteria include patients willing to provide consent and diagnosed with type 2 diabetes, while exclusion criteria encompass those with severe illnesses, psychiatric conditions, pregnant or lactating women, and patients with type 1 diabetes. The study will span eight months, from July 2025 to February 2026. Data collection will involve a demographic and clinical details form, alongside the Heart Disease Facts Questionnaire (HDFQ), a 25-item tool assessing knowledge of heart disease risk factors in diabetic patients. The HDFQ will be translated into Kannada and Malayalam, validated through a forward-backward translation process, and assessed for reliability using the test-retest method and Cronbach’s alpha. Statistical analysis will be performed using SPSS software version 29.0, with qualitative data expressed as frequency and percentage, and quantitative variables as (mean, standard deviation, median). Logistic regression will identify factors linked to knowledge levels, with a significance threshold set at a p-value of 0.05 or lower.
Anticipated outcome This study will give
insights on risk factors knowledge levels about heart disease of the diabetes
patients. This study also will provide the information on factors associated
with knowledge levels about the heart disease among the diabetes patients.
|