Annexure -1

Proforma to be submitted to the A.C.S. Medical College and

Hospital, Chennai Institute Ethics committee

Title of the Project To Evaluate the Awareness of

Hypertension and Factors associated
with hypertensive people.
Name of the investigator Anaida Carmel D’coutho

Name of co-investigator (s)

V. Divakar, T. JayaKodi,
M.Vedhaashya, E. Santhana Lakshmi
Name of the Guide Ms. Annie Caroline. P
Source of funding Not applicable
Objectives of study To estimate the level of awareness on
hypertension and factors associated with
hypertensive people.
Justification for conduct of study The worse quality of life of individuals
with hypertension is more evident in
patients under treatment.
Methodology – it should provide detail Enclosed
of number of patients, inclusion criteria,
exclusion criteria, control(s), study
design
Ethical issue involved in study
Cost involved Not applicable
Permission from Drug Controller Not applicable
General of India, if applicable
Whether consent form in local language Enclosed
is enclosed
Conflict of interest for any other No
investigator, if any

Signature of investigator
 STUDY PROTOCOL
BACKGROUND

Hypertension, is a chronic illness is a growing condition in our society, due

to life style changes. Once it is diagnosed, it depends on adapting a healthy
lifestyle and therapeutic compliance.

Hypertension is the silent killer disease of today and the single most
important predictor of cardiovascular risk. High BLOOD PRESSURE is
responsible for 7.6 million deaths per annum worldwide (13.5% of the total) , more
than any other risk factors. Around 54% of stroke and 47% of coronary heart
disease are attributable to high BLOOD PRESSURE.

Hypertension is defined as a consistent elevation of systolic blood pressure

>140 mm of Hg and consistent elevation of diastolic blood pressure >90 mm of
Hg.

In 2017 the American heart Association published new guidelines for

Hypertension management and defined hypertension as BLOODPRESSURE above
130/80mmHg rather than 140/90.

Categories in the new guideline are

Normal:- less than 120/80mmHg

Elevated:-systolic between 120-129 and diastolic less than 80.
Stage 1:- systolic between 130- 139 or diastolic between 80-89.
Stage 2:- systolic at least one 140 or diastolic at least 90mmHg.
Mainly, Hypertension is of two types:-Primary (essential) hypertension and
Secondary hypertension. Primary hypertension is non-identifiable cause.
Secondary hypertension is when high blood pressure is the result of medical
problems occurring in the kidneys, arteries, heart, or endocrine system.

Thus, this study is to examine the level of knowledge among Hypertensive

People, about hypertension and Factors Associated with hypertension.
OBJECTIVES:

To estimate the level of awareness on hypertension and factors associated

with hypertensive people.

METHODOLOGY:

Type of Study: Questionnaire study

Sample size: 100

Inclusion Criteria

 Patient diagnosed with essential hypertension.

 Age above 18years
 Patients of either sex

Exclusion Criteria

 Below 18 years
 Pregnancy Induced Hypertension

Methods:
The study is done by distributing survey questionnaire to 100 hypertensive
patients selected randomly by volunteer sampling and survey questionnaire
consists Socio-demographic characteristics which includes personal information,
assessment of awareness of hypertension and factors associated with hypertension.
 PROFORMA
1. NAME :

2. AGE :

3. HEIGHT :

4. WEIGHT :

5. BMI :

6. GENDER : Male

Female

7. EDUCATIONAL QUALIFICATION : Educated Uneducated

8. OCCUPATION :

9. DID YOU HEARD THE TERM “HYPERTENSION”

YES NO

10. ARE YOU AWARE OF HYPERTENSION

YES NO

11. DO YOU HAVE ANY CO-MORBID STATUS

SUGAR
HEART DISEASES
OBESITY
CHOLESTROL
ALL OF THESE

12. HABITS
SMOKING
ALCOHOLIC
TOBACCO
NONE

13. FOR HOW LONG DO YOU HAVE HIGH BLOOD PRESSURE

< 1 Yrs 5 to 10 Yrs

2 to 3 Yrs >10 Yrs
14. WHERE DID YOU DIAGNOSED WITH HIGH BLOOD PRESSURE.
HOME MONITORING
PRIMARY HEALTH CARE
ACS HOSPITAL
GOVERNMENT HOSPITAL
PRIVATE HOSPITAL
15. DO YOU GO FOR ROUTINE CHECKUP
YES
NO
ONCE IN A WHILE
IF YES, HOW AND WHERE:- ________________

HOME MONITORING
PRIVATE CLINICS
PRIMARY HEALTH CENTERS
ACS HOSPITAL
GOVERNMENT HOSPITAL

16. HOW OFTEN DO YOU SEE YOUR DOCTOR FOR BLOOD PRESSURE CHECKUP
DAILY
WEEKLY
MONTHLY
WHEN NEEDED

17. DO YOU MEASSURE BLOOD PRESSURE AT HOME

YES
NO

18. DOES HIGH BLOOD PRESSURE AFFECTS THE ABILITY TO PERFORM YOUR
DAILY ACTIVITIES
YES
NO

19. HAVE YOU EVER BEEN INTO AN EMERGENCY DUE TO HGH BLOOD
PRESSURE.
YES
NO
20. DO YOU TAKE ANY MEDICATIONS TO CONTROL YOUR BLOOD PRESSURE

YES NO

IF YES, NAME THE DRUG :______________

ACE INHIBITORS

BETA BLOCKERS

CALCIUM CHANNEL BLOCKERS

DIURETICS

21. HOW LONG HAVE YOU BEEN TAKING MEDICATION

<1YR
1 TO 2 YRS
>2YRS

22. TYPE OF YOUR DIET

VEG:
Green leaves
Pulses
Cereals
Dairy products
NON VEG:
Chicken
Mutton
Red meat
Sea food

23. HAVE YOU EVER THOUGHT ON REDUCING SALT INTAKE

YES
NO

24. DO YOU KNOW THE CAUSES OF HIGH BLOOD PRESSURE,

AGE, CHOLESTEROL, SUGAR, SMOKING,ALCOHOL,FAMILY HISTORY.

YES

NO
25. HAVE YOU EVER THOUGHT ABOUT CHANGING YOUR LIFESTYLE TO
CONTROL YOUR BLOOD PRESSURE.

YES
NO

26. DO YOU KNOW THAT OBESE PEOPLE ARE MORE PRONE TO HYPERTENSIVE
HEART DISEASES

YES NO

27. HAVE YOU EVER SUFFERED FROM ANY OF THE FOLLOWING SYMPTOMS
SHORTNESS OF BREATH
CHEST PAIN
LOSS OF CONSCIOUSNESS
DIZZINESS
PALPITATION

28. DOES YOUR BLOOD RELATIONS HAVE A HISTORY OF HIGH BLOOD

PRESSURE
YES
NO

29. ARE YOU AWARE OF THE COMPLICATIENTS OF HYPERTENSION

STROKE, RENAL FAILURE, CARDIAC ARREST, BLINDNESS

YES

NO

30. YOUR AVERAGE BLOOD PRESSURE LEVELS

130/90mmHg

140/90mmHg

150/95 to 200/100mmHg

>200/100mmHg
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 >200\100 mmHg

VOLUNTARY CONSENT BY THE PARTICIPATION

PARTICIPATION IN THIS STUDY IS COMPLETELY VOLUNTARY, AND

YOUR CONSENT IS REQUIRED BEFORE YOU CAN PARTICIPATE IN THIS
STUDY.

I have read this consent form (or it has been read to me) and I fully understand the
contents of this document and voluntarily consent to participate in this study. If I
have any questions in the future about this study, they will be answered by the
investigator listed above. I understand that this consent ends at the conclusion of
this study.

Principle Investigator: Anaida Carmel D’coutho

Contact Number: 7907773863

E-mail id: carmenanaida@gmail.com

By signing this form, I agree to participate in this study.

Date: Participant’s Signature

Address:
Ph No: Name:

VOLUNTARY CONSENT BY THE PATIENT’S RELATIVE

(in case the patient is unfit to consent himself/herself).
PARTICIPATION IN THIS STUDY IS COMPLETELY VOLUNTARY, AND
YOUR CONSENT IS REQUIRED BEFORE YOU CAN PARTICIPATE IN THIS
STUDY.

I have read this consent form (or it has been read to me) and I fully understand the
contents of this document and voluntarily consent to participate in this study. If I
have any questions in the future about this study, they will be answered by the
investigator listed above. I understand that this consent ends at the conclusion of
this study.

Principle Investigator: Anaida carmel D’coutho

Contact Number: 7907773863

E-mail id: carmenanaida@gmail.com

By signing this form, I agree to participate in this study.

Date: Participant’s Signature

Address:
Ph No: Name:

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njhiyNgrp vz;: 7907773863

kpd;dQ;ry;: carmenanaida@gmail.com

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Kjd;ik Ma;thsh;: midlh fhh;nky; b’NfhNjh

njhiyNgrp vz;: 7907773863

kpd;dQ;ry;: carmenanaida@gmail.com

vd;Dila ifnahg;gj;jpd; %ykhf vd;Dila tpUg;gj;ij njhptpj;Jf; nfhs;fpNwd;.

Njjp: gq;Fnfhs;Nthhpd; ifnahg;gk;

Kftup:

njhiyNgrp vz;: ngah;:

 CERTIFICATION OF INFORMED CONSENT

I certify that I have explained the nature and purpose of this study to the above-
named individual, and I have discussed the potential benefits of this study
participation. The questions, the individual had about this study have been
answered, and we will always be available to address future questions.

Date: Signature of person obtaining consent

Signature of PI Name:

தெரிவிக்கப்பட்ட ஒப்புதலின் சான்று

மேலேகுறிப்பிடப்பட்டுள்ளநபரிடம்இந்தஆய்வின்தன்மைமற்றும்நோக்கத்தைவிளக்
கிவிட்டேன்என்றுசான்றளிக்கிறேன்.
இந்தஆய்வில்பங்கேற்பதனால்கிடைக்கக்கூடியநன்மைகளைப்பற்றியும்கலந்துரையா
டிஇருக்கிறேன்.
இந்தஆய்வைக்குறித்துஇவருக்குஇருந்தசந்தேகங்கள்நிவர்த்திசெய்யப்பட்டன.மேலு
ம்>வருங்காலத்தில்எழக்கூடியகேள்விகளுக்குபதிலளிக்கதயாராகஇருப்போம்.

தேதி: ஒப்புதல்பெறுபவரின்கையொப்பம்
மேற்பார்வையாளரின் கையொப்பம் பெயர்:

CURRICULUM VITTAE

NAME: Ms. Anaida Carmel D’coutho

ADDRESS : Appartment No.L4, Jamals Granduer, Cauvery Nagar Main

Road, Thiruverkadu. Chennai-77

E-MAIL ID: carmenanaida@gmail.com

PHONE NUMBER: 7907773863E

NAME TITLE DATE OF BIRTH

Anaida Carmel To evaluate the awareness 11/07/1999
D’coutho of hypertension and factors
associated with
hypertensive patients

EDUCATION

INSTITUTION QUALIFICATIO YEAR

N
ACS Medical College Bsc. Cardiac Perfusion 2017-2021
Techniology

LFCHS Koratty,Kerala HSC 2017

Little Flower Public SSLC 2015
school, Muringoor,
Kerala