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CTRI Number  CTRI/2012/01/002380 [Registered on: 25/01/2012] Trial Registered Retrospectively
Last Modified On: 10/01/2012
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   An estimate of non-communicable diseases in rural areas derived form a house to house survey of 5 panchayaths. 
Scientific Title of Study   Epidemiology of Non-Communicable diseases in Rural Areas. 
Trial Acronym  ENDIRA 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1126-7873  ISRCTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jaideep C Menon 
Designation  Cardiologist 
Affiliation  MAGJ Hospital, Mookkannoor 
Address  DOCTORS QUARTERS MAGJ HOSPITAL MOOKKANNOOR KERALA
" KALYANI CHANAYIL " FLAT NO VI TOP CONSTRUCTIONS MACHINGAL LANE THRISSUR
Ernakulam
KERALA
683577
India 
Phone  04842615700  
Fax  04842616789  
Email  menon7jc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaideep C Menon 
Designation  Cardiologist 
Affiliation  MAGJ Hospital, Mookkannoor 
Address  DOCTORS QUARTERS MAGJ HOSPITAL MOOKKANNOOR KERALA
" KALYANI CHANAYIL " FLAT NO VI TOP CONSTRUCTIONS MACHINGAL LANE THRISSUR
Ernakulam
KERALA
683577
India 
Phone  04842615700  
Fax  04842616789  
Email  menon7jc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jaideep C Menon 
Designation  Cardiologist 
Affiliation  MAGJ Hospital, Mookkannoor 
Address  DOCTORS QUARTERS MAGJ HOSPITAL MOOKKANNOOR KERALA
" KALYANI CHANAYIL " FLAT NO VI TOP CONSTRUCTIONS MACHINGAL LANE THRISSUR
Ernakulam
KERALA
683577
India 
Phone  04842615700  
Fax  04842616789  
Email  menon7jc@gmail.com  
 
Source of Monetary or Material Support  
MAR AUGUSTINE GOLDEN JUBILEE HOSPITAL 
 
Primary Sponsor  
Name  MAGJ HOSPITAL 
Address  MAR AUGUSTINE GOLDEN JUBILEE HOSPITAL MOOKKANNOOR,683577, KERALA KERALA 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaideep C Menon  DEPARTMENT OF CARDIOLOGY,MAGJ HOSPITAL  DEPARTMENT OF CARDIOLOGY,MAR AUGUSTINE GOLDEN JUBILEE HOSPITAL, MOOKKANNOOR MOOKKANNOOR 683577
Ernakulam
KERALA 
04842615700
04842616789
menon7jc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAGJ Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Non- communicable diseases 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Survey in the general population 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of non communicable diseases  Prevalence of non communicable diseases by way of an oral questionnaire at a single point of time 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="100000"
Sample Size from India="100000" 
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)   04/01/2012 
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)  Open to Recruitment 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

         E N D I R A – Epidemiology of Non-communicable Diseases in Rural                                           Areas.

 

Introduction- With the increase in life expectancy non-communicable diseases ( NCD ) has out stripped infectious and nutrition related diseases as the major cause of morbidity and mortality in present day India.

     The prevalence of the so called life style related diseases, cancer and respiratory diseases are on the increase. The age of onset of these disease conditions is at a much earlier age than what is seen in the West.

  The reasons for this are many and would include

-       rapid urbanization and industrialization

-       rural to urban area migration

-       changing diet patterns especially in urban areas

-       increasing tobacco and alcohol use and from an earlier age

-       sedentary life styles specially so in urban areas

-       stresses of daily living in a competitive world specially so after the opening up of the economy and globalization

-       pollution

-       increasing prevalence of obesity

-       lack of awareness of the disease conditions and their potential consequences

  An individual admitted with a cerebro-vascular accident who is less than 45 years of age is more likely to be a male from the lower socio-economic strata ( SES )and a tobacco abuser. What was previously considered a domain of the rich is increasingly being seen in the lower SES.

 

Aim -The aim of the ENDIRA group was to look at the NCD profile of a population of 100,000 individuals in a rural area.

  This was coupled with an intervention by way of an audio-visual presentation documenting the ills related to tobacco and alcohol. The CD was presented in all the high schools of the respective panchayats. For an adult audience there were two other AV presentations on Diet & Exercise and Yoga& Meditation. The rationale being that educated children could pressurize their parent to quit tobacco and alcohol more effectively.

 

Methods- Five adjacent panchayats namely Mookkannoor (13 wards ), Karukutty(16 wards), Manjapra(13 wards), Thuravoor(14 wards) and Kalady were identified. The panchayats are all located in Ernakulam district of central Kerala.

 After an initial briefing of the panchayat committee and grant of permission, a training/orientation of the ASHA’s ( Accredited Social Health Activist ) and Kudumbashree workers is done. The ASHA’s are shown as to how to fill the questionnaire. The survey books, three( 150 pages each ) in all are given with a measuring tape and a weighing machine are what comprise a kit. It was demonstrated to the ASHA’s as to how to take the height and weight and how to make the entries.Telephone number of the PI was given to each individual ASHA in case she had any queries during the course of the survey.

  In parallel a video presentation called N2T-A ( no to Tobacco & alcohol ) was shown to the school and PTA representatives of higher secondary schools in the panchayat. Permission was taken from the school authorities to screen the video for their higher secondary classes, namely Std V11-X.

  The data was entered on a program written such as to be able to run a search on each of the individual conditions entered or on any combination.

 

The survey was started after clearance from the ethics committee of the MAGJ Hospital, Mookkannoor.

 

  The details of a single family are entered on a single page.

Names of the individual family members, respective age, sex, educational status, height in cm, weight in kg along with the “ House name “, telephone number, ward number and name, Panchayat APL/BPL status are entered.

  The importance of the “ House “ is in the fact that in Kerala the initials of an individual represent the name of the house he belongs to and not to the village like in some other parts of the country. One is identified by the house one belongs to. For example PP George would be Pynadath Poulose George in which the first P –Pynadath stands for his house name by which he is identified.

 The disease conditions questioned for include

   Diabetes mellitus- present/absent/do not know, when detected (year), mode of treatment whether diet/OHA/insulin

  Hypertension- yes/ no/DNK and duration if yes. Duration is always entered as the year in which it was picked up.

  Dyslipidaemia- Yes/No/DNK, duration if yes.

  Alcohol consumption in pegs per week, country liquor or Indian made foreign liquor.

  Use of tobacco products yes/No. usage per day, duration

  Amount of non vegetarian food items bought in a month this when entered in the data sheet was entered per week. The amount of meats excluded fish.

  Type of oil used by the household and the amount used per month.

  

  Whether the individual has undergone any surgery, and the body part operated upon.

   Presence of any chronic respiratory conditions, duration.

   Presence of cancer and where if yes.

   H/O death due to cancer in the family.

   H/O snake bite, any death due to snakebite in the family.

   H/O CAD in the family and duration.

   H/O CVA in the family and duration.

 

Details of a single individual are entered as a single entry on the data sheet.

 

The weighing machines and the tapes were calibrated before and after use. The details of individuals were verified by

-       medical camps conducted at the end of data entry of each panchayat, where fasting blood sugar and cholesterol were checked for

-       every 25th family was contacted by telephone if possible and the details entered tallied, in the rare instance that the family could not be contacted the next family on the list was contacted

-       individuals from the surveyed areas seen as out patients were cross checked for the veracity of details entered

   

 

DISCUSSION

 

Extrapolation of the data to the state and national levels would very much help health authorities in planning for expenditure on health at both central and state levels.

More intervention by way of educating the public should help decrease the incidence of lifestyle diseases and the complications secondary to it.

‘ CATCH THEM YOUNG” should be our motto. This could mean two things

  Firstly early detection of the life style diseases before they actually manifest, for example as pre-HTN, an impaired glucose tolerance or as borderline dyslipidaemia.  Appropriate life style changes by way of

-       weight reduction

-       regular exercise

-       cutting down on the red meats and the quantity consumed

-       abstinence from alcohol and tobacco use

-       plenty of green leafy vegetables and  fruits

-       cutting down on salt consumption

-       yoga and meditiation

should all go a long way in making our community a healthier community.

 

Secondly it could also mean educating the children at an impressionable age about what a healthy living really is. About the ills related to tobacco, alcohol etc.

The aim is to create a women & child lobby who would stridently protest about continued alcohol and tobacco use and would in time make the government ban the use of tobacco products.

 

  Dr Jaideep C Menon

  Cardiologist, MAGJ Hospital

  Mookkannoor 683577

 

Mob 094473-52684

 

 
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