| CTRI Number |
CTRI/2018/07/014856 [Registered on: 13/07/2018] Trial Registered Prospectively |
| Last Modified On: |
11/07/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
population based study in which each individual is assessed |
| Study Design |
Other |
|
Public Title of Study
|
SHRADDHA- State government sponsored program for awareness and early detection of NCDs (non-communicable diseases) |
|
Scientific Title of Study
|
NCD (non-communicable Diseases) screening and establishment of primary laboratories in PHCs and taluk hospitals of eastern region of Ernakulam district. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaideep C Menon |
| Designation |
Cardiologist |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department od Adult Cardiology, Amrita Institute of Medical Sciences, Ponekkara, Ernakulam 682041
3/113A,Janaki Mandiram, Kothakulangara,ANGAMALY
Ernakulam
KERALA
683572
India |
| Phone |
09447352684 |
| Fax |
04842802120 |
| Email |
menon7jc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaideep C Menon |
| Designation |
Cardiologist |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Adult Cardiology, Amrita Institute of Medical Sciences, Ponekkara,Ernakulam 682041
3/113A,Janaki Mandiram, Kothakulangara,ANGAMALY
Ernakulam
KERALA
683572
India |
| Phone |
09447352684 |
| Fax |
04842802120 |
| Email |
menon7jc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaideep C Menon |
| Designation |
Cardiologist |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Adult Cardiology, Amrita Institute of Medical Sciences, Ernakulam 682041
3/113 A,Janaki Mandiram, Kothakulangara,ANGAMALY
Ernakulam
KERALA
683572
India |
| Phone |
09447352684 |
| Fax |
04842802120 |
| Email |
menon7jc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharat Petroleum Corporation Limited,
Bharat Bhavan II,
5th Floor4 & 6 Currimbhoy Road, Ballard Estate,
Mumbai - 400001 |
|
|
Primary Sponsor
|
| Name |
Bharat Petroleum Corporation Limited India |
| Address |
Bharat Petroleum Corporation Limited, Mumbai |
| Type of Sponsor |
Other [CSR of Bharat Petroleum Corporation Limited] |
|
|
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 |
| Jaideep C Menon |
Department of Adult Cardiology, Amrita Institute of Medical Sciences |
Amrita Institute of Medical Sciences and Research Centre,Ponekkara P.O., KOCHI - 682041
Ernakulam
KERALA |
09447352684
04842802120
menon7jc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
population study for assessment of NCDs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
the study intends to look at life style and prevalence of non-communicable diseases in the general population. All individuals more than 30 years in 27 panchayats and 4 municipalities would be so assessed |
|
| ExclusionCriteria |
| Details |
individuals unable to or unwilling to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
prevalence of NCDs in the general population,
- life style habits leading to the same |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
nil |
|
|
Target Sample Size
|
Total Sample Size="650000"
Sample Size from India="650000"
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)
|
24/07/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Potential for the use of m-Health in the management of cardiovascular disease in Kerala: A qualitative study - Nov- 2015, British Medical Journal, Open
2. Below the poverty line and non-communicable diseases in Kerala: The Epidemiology of Non-communicable Diseases in Rural Areas (ENDIRA) study, April 2015, International Journal of Cardiology
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Non communicable diseases are responsible for over 53% of deaths in India. Prevalence of diabetes, hypertension and dyslipidemia is on the increase. If these disease conditions are picked up early and treated along with life-style changes implementation, which would include abstinence from tobacco and alcohol, regular exercise and healthy diet, this would most definitely prevent the current pandemic of cardio-vascular disease that we now encounter. It is most important to be able to identify the at risk group so as to be able to bring about lifestyle changes. The ENDIRA investigators along with the district NHM had previously carried out a survey in 114,064 individuals of 5 panchayats in Ernakulam district. The prevalence of diabetes/HTN/Dyslipidemia was high and more importantly 60% of individuals with HTN /diabetes and 91% with a high cholesterol were not aware of that. With this in mind the ENDIRA investigators along with the district NHM submitted a proposal to the BPCL as a part of their CSR through the offices of the MP of Chalakudy constituency Shri Innocent, which got sanctioned. In this present study- "SHraddha-ENDIRA" we plan to survey all individuals in 27 panchayats and 3 municipalities for NCD’s through ASHA workers going to to house in their respective wards.Details would be entered on Tab PC’s with a software written for the same. All individuals > 30 years would have their sugars(glucometer), BP (digital BP) measured in this population of over 650,000. Individuals with high values on home checks are routed to the nearest PHC. All PHC’s of the 27 would be provided with semi-automatic analysers and all community/taluk and district hospitals with a fully automated analyser for bio-chemical analysis. This would work on a spoke and hub pattern. Each hub (CHC/THC/District hospital) subserving 9 spokes (PHC’s). Referral for a comprehensive analysis would ba along the same lines. With this we believe we would making more health aware and conscious besides strengthening the public health system in this area. We believe that the same model could be replicated elsewhere to the benefit of the community and the country. This is the largest community based screening program in India as of now.
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