| CTRI Number |
CTRI/2025/02/081113 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Healthcare Services for Chronic Diseases in Udupi District |
|
Scientific Title of Study
|
Strengthening of health system capacity and service delivery with a focus on Non-Communicable Diseases in Udupi district |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Cherian Varghese |
| Designation |
Director and Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no.1,Director cabin,1st floor,Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8281458226 |
| Fax |
|
| Email |
cherian.varghese@manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Cherian Varghese |
| Designation |
Director and Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no.1, Director cabin, 1st floor, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
KARNATAKA 576104 India |
| Phone |
8281458226 |
| Fax |
|
| Email |
cherian.varghese@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Anupama DS |
| Designation |
Assistant Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no. 27, 1st floor, Department of Health Technology and Informatics, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8762769544 |
| Fax |
|
| Email |
anupama.s@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education (MAHE), Madhavanagar,Manipal,Karnataka,India - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education (MAHE), Madhavanagar,Manipal,Karnataka,India - 576104 |
| Type of Sponsor |
Other [Academic Institution ] |
|
|
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 Anupama DS |
Prasanna School of Public Health |
Room no.1, 1st floor, Department of Global Public Health Policy and Governance Udupi KARNATAKA |
8762769544
anupama.s@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic patients are available during the time of data collection and visiting public healthcare facilities for testing their glycemic levels/treatment. |
|
| ExclusionCriteria |
| Details |
Patients not willing to test for glycemic levels |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comprehensive data on the capacity of selected healthcare facilities in Udupi District to manage Non-Communicable Diseases (NCDs).
Workflow Analysis of Healthcare Providers and recommendations for optimizing the workload.
Point-of-care testing initiative demonstrates the potential to assess the glycemic control. |
Baseline, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Scalable model- the developed model could be utilized for proposing incremental improvements such as better resource allocation, workforce training & NCD service delivery. |
Baseline, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="490" Sample Size from India="490"
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)
|
05/03/2025 |
| 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="1" Months="0" 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
|
In India, NCDs account for approximately 60 percent of all deaths, making them a critical public health concern. The Government of India has initiated the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD) to address the major NCDs, including hypertension, diabetes, cardiovascular diseases, cancer, stroke, chronic kidney disease, COPD/asthma, and non-alcoholic fatty liver disease. The National Family Health Survey (NFHS-5) highlights the prevalence of NCDs in the Udupi District. There is a pressing need to assess the current capacity and service delivery for NCDs in Udupi District to identify gaps and areas requiring improvement. Evidence suggests that many health facilities in low- and middle-income countries, including India, lack adequate infrastructure, trained personnel, and essential medicines to provide comprehensive NCD care. Studies also point to inefficiencies in healthcare work patterns, including excessive time spent on administrative tasks, emphasizing the need for targeted policy interventions, reallocation of responsibilities, and improved work processes to streamline healthcare delivery. This study aims to Evaluate the capacity of healthcare workers in Udupi District, Propose strategies to enhance the efficiency of NCD management and Develop a scalable model to strengthen health system capacity for managing NCDs. Additionally, the PSPH research team has done the evaluation of the Grama Arogya program, which is now merged with the Gruha Arogya Scheme launched by the Government of Karnataka, focuses on screening for common NCDs such as diabetes, hypertension, cancers, obstructive sleep apnea, and mental health conditions. This project aligns with the scheme and aims to improve early disease detection and community health outcomes. |