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CTRI Number  CTRI/2024/01/061485 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening
Other (Specify) [Educational]  
Study Design  Other 
Public Title of Study   screening for High blood screening, high blood sugar, and certain important risk factors for heart diseases among patient bystandares 
Scientific Title of Study   Opportunistic screening for non-communicable diseases and selected cardiovascular risk factors among caregivers in a teaching hospital – quasi expiremental trial 
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 Sebin B Chirayath 
Designation  junior resident 
Affiliation  Kasturba Medical College, MANIPAL 
Address  Dept. of Community Medicine, Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576107
India 
Phone  9008370744  
Fax    
Email  sebin.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Sneha Deepak Mallya 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Community Medicine Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  988089331  
Fax    
Email  sneha.kamath@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Sneha Deepak Mallya 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Community Medicine Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  988089331  
Fax    
Email  sneha.kamath@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Private medical college 
 
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 Sebin Chirayath  Kasturba Medical College, Manipal  Department of Community Medicine, Third floor, Biochemistry block, Kasturba Medical College, Manipal Manipal Academy of Higher Education, Manipal-Pin-576104 Karnataka , India
Udupi
KARNATAKA 		 9008370744

sebin.kmcmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently healthy people will be screened for hypertension, diabetes and CVD risk factors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard Medical advice   Those with high BP and sugar will receive standard medical advice once during the first interview and the outcome will be assessed after 1 month from the date of first interview. Duration of advice: 5 minutes 
Intervention  Video based counseling   Those with high BP and sugar will receive video based counseling once during the first interview and the outcome will be assessed after 1 month from the date of first interview. Duration of video: 5 minutes 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Care givers of hospitalized patients visiting Kasturba hospital, Manipal and aged 30-60 years   
Has not been screened for hypertension and diabetes in last one year  
If an individual has only diabetes or hypertension and has not been screened for either disease in last one year, such people will be included 
 
ExclusionCriteria 
Details  Care givers of hospitalized patients visiting hospital ,with known history of diabetes and hypertension. Pregnant women caregivers, bystanders of ICU patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of people with elevated blood pressure and elevated sugar level and any of the cardio vascular disease risk factors like unhealthy diet, use of tobacco, use of alcohol, limited physical activities and Impact of video assisted counseling and standard medical advice on healthy seeking behavior of elevated blood pressure and elevated sugar level   Outcome measured at one point only. The health seeking behavior for identified risk factors assessed at end of one month 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="953"
Sample Size from India="953" 
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)   19/01/2024 
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="2"
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   The study aims at understanding the feasibility of opportunistic screening for hypertension, diabetes and select cardiovascular risk factors among patient caregivers in a teaching hospital with two main objectives of screening patient caregivers of hospitalized patients for hypertension, diabetes and selected CVD risk factors and  to evaluate the effectiveness of video assisted counselling on health seeking behavior for hypertension and diabetes. Participants who meet the study criteria will be identified and provided with questionnaires. Anthropometric measurements will be taken from these participants and their blood pressure and blood sugar levels will be estimated. Following this,  a subsample will be part of quasi experimental study and the participants will be categorized into two groups. One group will include participants with elevated blood pressure and blood sugar levels and the other group will include participants with normal blood pressure and blood sugar levels. The group of participants with elevated blood pressure and blood sugar levels will be allotted with odd and even numbers according to the serial number. All the individuals with even numbers will receive video assisted counselling and will be called for a follow up after a period of one month. The individuals with odd numbers will receive standard medical advice and will be called for follow up after one month. 
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