| CTRI Number |
CTRI/2024/06/068423 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
quality of life among diabetes patients |
|
Scientific Title of Study
|
Quality of life and its associated factors among patients with diabetes mellitus: A cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Bahadur Singh |
| Designation |
Post graduate student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of public health, room No: 201, K S Hegde medical academy, Deralakatte, Mangalore,
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7302225713 |
| Fax |
|
| Email |
deepaksinghh416@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mackwin D’mello |
| Designation |
Associate professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of public health,room no:201, K S Hegde medical academy, Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
Mackwin@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mackwin D’mello |
| Designation |
Associate professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of public health, room no:201, K S Hegde medical academy, Deralakatte, mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
Mackwin@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| justice k S hegde charitable hospital, Deralakatte, Manglaluru-575018, India |
|
|
Primary Sponsor
|
| Name |
Deepak Bahadur Singh |
| Address |
Derlakatte , Mangaluru-575018, India |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Deepak Bahaudur Singh |
Justice K S Hegde charitable hospital |
department of general medicine, endocrinology, room no: 9, Derlakatte, Mangalore
Dakshina Kannada
KARNATAKA |
7302225713
deepaksinghh416@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| KS Hegde Medical Academy |
Approved |
| KS Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 18 years and above with diabetes Mellitus.
Patients visiting department of general medicine with diabetes mellitus.
Patients with type 1 diabetes, type 2 diabetes and gestational diabetes mellitus.
|
|
| ExclusionCriteria |
| Details |
Individuals who is 17 years and younger with diabetes mellitus.
Those who are not willing to participate in the study and suffering from life threating complications of diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life and it’s associated factors among diabetes patients. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors associated with quality of life among diabetea patients |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="403"
Sample Size from India="403"
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)
|
16/06/2024 |
| 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="2"
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, a chronic condition with physical, emotional, and social ramifications, necessitates a comprehensive understanding of its impact on patients’ lives. By conducting an advanced research study within a hospital setting, we seek to unravel the intricate dynamics between medical management, lifestyle factors, and psychological well-being in the context of diabetes. The outcomes of this research are anticipated to contribute valuable insights to healthcare practitioners, policymakers, and researchers, fostering the development of tailored interventions and comprehensive care strategies to improve the overall quality of life for individuals grappling with diabetes in a hospital environment.
|