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Study Protocol

Estimation of prevalence of risk factor of hypertension among population of Wardha district between age group of 35-60 years: a study protocol.

[version 1; peer review: 1 approved with reservations]
Amruta Dadmal
https://orcid.org/0009-0000-4913-4876
1, Gaurav Mude2
Amruta Dadmal
https://orcid.org/0009-0000-4913-4876
1, Gaurav Mude2
PUBLISHED 21 Aug 2023
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

A serious medical condition known as hypertension or elevated blood pressure significantly rises the risk of brain, heart, kidney, and other medical conditions. It is the most common cardiovascular disease globally and is now recognized as a major health issue that needs to be addressed. It serves as a warning sign for serious illnesses including myocardial infarction, stroke and renal failure. An estimated 46% of the population with hypertension are not aware of the condition they have. Only 42% of those diagnosed with hypertension receive a diagnosis and treatment.  21% (1/5) of the population who have hypertension have it under control. Around the world, high blood pressure (HBP) is a main cause of early death. Knowledge on the prevalence of risk factors for hypertension is needed because there are relatively few community-based research projects on the condition. The objective of this study is to assess the prevalence of hypertension risk factor in the Wardha district in the state of Maharashtra in western India. A cross-sectional study will be performed. The study’s strength lies in the use of a standardized risk factor check list, which will ensure consistency in data collection and minimize bias. The use of a large sample size (165 patients) will also improve the precision of study and increase the generalization of the result.

Keywords

Hypertension, Risk factors, Prevalence, Blood pressure, Cardiovascular-disease

Corresponding author: Amruta Dadmal
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2023 Dadmal A and Mude G. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Dadmal A and Mude G. Estimation of prevalence of risk factor of hypertension among population of Wardha district between age group of 35-60 years: a study protocol. [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1016 (https://doi.org/10.12688/f1000research.135188.1) First published: 21 Aug 2023, 12:1016 (https://doi.org/10.12688/f1000research.135188.1) Latest published: 16 Oct 2023, 12:1016 (https://doi.org/10.12688/f1000research.135188.2)

Introduction

Blood pressure (BP) is the force of the blood exerted on the walls of arteries as a result of the left ventricle contracting against the resistance provided by the arteries and arterioles, which is necessary for the best possible functioning of the body.1 HBP is the medical term for elevated BP. The BP is addressed as two numbers. The Systolic pressure, which is the first number, is the blood vessel pressure produced when the heart contract or beats. The Diastolic pressure which is the second number indicates the pressure in the arteries between heartbeats.2

HBP is regarded as the third most crucial element of danger for the associated burden of illness in South Asia. In India, the impact of hypertension (HTN) on the cardiovascular healthcare system and health status is significant. In India, hypertension is mainly accountable for more than 50% of all deaths from stroke and more than 20% of all fatalities from CDH (coronary heart disease) and according to World Health Organization (WHO), one of the main global elements of risk for early death is hypertension.3

The principal factor adding to cardiovascular mortality and morbidity is hypertension.4 Experts on hypertension continue to disagree on the HBP threshold that constitute abnormality, based on epidemiological and intervention research, the generally recognized criteria is systolic blood pressure (SBP) > or = 140 mmHg and/or diastolic blood pressure (DBP) > or = 90 mmHg.5 Adult blood pressure is divided into stages. Health and physical risks increase with each stage. These stages vary from normal, elevated (SBP 130-139mm Hg and DBP 80-89 mmHg), stage 2 Hypertension (SBP 140 mmHg and up and 90 mmHg and up), and hypertension crisis (SBP 180 mmHg and up and DBP 120 mmHg and up), a hypertension crisis is a sudden rise in blood pressure rise in blood pressure that can result in a stroke and is recorded at 180/120.6

BP by age and gender also vary from; 18–39-year male (119/70 mmHg) and female (110/68 mmHg), 40-59 years male (124/77 mmHg) and female (122/74 mmHg), 60 + years male (133/69 mmHg), and female (139/68 mmHg).6

According to epidemiological research, in India the prevalence of hypertension has been continuously rising over the past 40 years, with urban areas experiencing this trend more than rural ones.5 Based on The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) standard which was published 2003 and the American College of Cardiology/American Heart Association (ACC/AHA) guideline, Hypertension prevalence based on sex and age was 22.3% (95% CI: 20.6, 24.1) and 36.5% (31.1, 41.8), respectively.7

Primary hypertension & Secondary hypertension are the two main assortments of hypertension.

Essential hypertension, which is commonly called as primary hypertension, is a multifactorial form of HBP that has multiple causing factors. It is often referred to as essential or idiopathic hypertension, anything above 120/80 mmHg is normally considered to be above normal, indicating that arteries are under more pressure than they should be. You are more likely to develop essential primary hypertension if you engage in unhealthy behaviours and certain situations.8 Other forms of hypertension have a unique root cause, including a medical condition or drug side effects. Secondary hypertension is the term used when there is a clear direct cause. Primary and secondary hypertension can coexist, and when there is an instant deterioration of BP, a new secondary cause should be considered.8

Secondary hypertension may frequently be cured effectively in order to minimize both the HBP & the disorder that causes it. The risk of major consequences, such as kidney failure, heart disease and stroke are decreased by effective therapy. Even if BP has risen to risky levels, secondary BP typically exhibits no particular symptoms, similar to primary hypertension. Secondary hypertension can result from many medical problems also secondary hypertension may be caused by a number of renal disorders, including: Polycystic kidney disease, Diabetes compilation (diabetic nephropathy), Renovascular hypertension, Glomerular disease, etc.9

Another type of hypertension is pregnancy-induced hypertension. Pregnancy-induced hypertension can be characterized as a disorder of conditions that happens following 20 weeks of pregnancy described by an expansion in circulatory strain to more than 140/90 mmHg regardless of proteinuria.10

A vital causal factor for stroke, long-term heart disease and coronary heart disease is high BP unhealthy diets, use of cigarettes and alcohol, inactivity, excessive salt consumption, being overweight or obese, diet high in saturated and trans fats, are some of the modifiable risk factors that may be altered.2 Non-modifiable risk factor of hypertension includes being older than 64 years, having a heredity of hypertension, and having other diseased condition like diabetes or renal disease; these risk factors cannot be altered.2 The aim of the proposed study is to estimate the prevalence of risk factor of hypertension among population of age group 35-60-years in Wardha district.

Objective

To assess the prevalence of risk factor of hypertension

To state the risk factor of hypertension

Protocol

Methodology

Type of study – Observational study (Cross-sectional)

Duration of study – 4 months

  • • The study will be a cross-sectional observational study, and will be carried out over a period of four months

  • • Conceptual research on hypertension will be done

  • • Prior to the initiation of the study permission will be obtained from the ethics committee

  • • The subject will be assigned, with the help of simple random sampling method

  • • The evaluation of prevalence of risk factor of hypertension will be done through face-to-face interview by using standardized risk factor check list

  • • Subjects will be provided Informed Consent, which will be filled after explaining the purpose of study

  • • Standardized risk factor check list will be given to the subject and will be filled by them

  • • The data collected will be tabulated and analysed

Study design

The study is about the prevalence of risk factor oh high BP. The study will be conducted among the hypertensive population of Wardha district. The recruitment of the subjects will be done independently, and the evaluation will be observed through a risk factor check list.

The subjects will be recruited using simple random sampling from various private and government hospitals in Wardha district.

Sample size11 – 165

Daniel formula for sample size:

n=Zα/22∗P1−Pd2

Where’s

Zα/2 is the level of satisfaction at 5% i.e. 95%

Confidence interval = 1.96

P = Prevalence = 29.8% = 0.298

d=7%=0.07=1.962×0.298×1−0.2980.072=164.009

n = 165

hence, 165 subjects will be needed in the study.

Selection of subject

Inclusion criteria:

  • 1. Males or Females with hypertension

  • 2. population between 35-60 years age group

Exclusion criteria:

  • 1. Age below 35 and above 60 years

  • 2. Clinical diagnosis of malignant tumour

  • 3. Pregnant/lactating women

Method of data collection

Instrument – Risk factor check list (see extended data)

The check list will include details of the subject such as Name of the subject, Age, Gender, blood pressure of the subject.

The check list will also include different risk factors of hypertension such as Age, Obesity, Genetic and Family history, Alcohol Consumption, Physical inactivity, etc.

Steps of data collection

Step 1: Permission will be obtained prior from the Ethics Committee for the data collection

Step 2: Introduction between the participants and the researcher

Step 3: The participants will be assigned by using random sampling method

Step 4: Written, informed consent will be taken from all the participants who are willing to participate, after explaining the study purpose

Step 5: Standardized risk factor check list will be filled out by the subjects with the help Of face-to-face interview

Step 6: The data collected will be tabulated and analyzed

Primary outcome

To state the risk factors of hypertension among hypertensive population of Wardha district.

Method of data analysis

Statistical analysis including standard deviation, mean, proportion, frequency, and percentage and inferential statistics comprising χ2 test, discriminants analysis and factor analysis will be used to analyse the data using Statistical Package for Social Sciences (SPSS)12 and Excel.

Dissemination

It will be published in an indexed journal.

Study status

Yet to be started.

Discussion

HBP is a notable cause of element of danger for stroke, chronic heart disease and coronary heart disease. Unhealthy diet (diets heavy in saturated and trans fats, excessive salt intake, insufficient intake of vegetables and fruits), use of tobacco and alcohol, inactivity, and being obese or overweight are some of the modifiable risk factors that can be changed. Family history of hypertension, having additional illness like diabetes or kidney disease and being over 65 years are all non-modifiable risk factors that cannot be changed.2

Cardiovascular morbidity and mortality are increased by hypertension by a factor of two to four. Atherosclerosis and coronary disease are now the main risks. The degree of diastolic or systolic BP elevation in either sex, at any age, is inversely correlated with risk of hypertension. Patients with hypertension who also have an impaired glucose tolerance, high-density/high total lipoprotein (HDL) - cholesterol ratio, abnormal electrocardiographic (ECG) results, high fibrinogen levels and who smoke cigarette are at a higher chance to develop coronary heart disease.13

HBP is a prime element of danger for heart attack and stroke and affects almost 30% of adults. Due to hypertension, the sympathetic nervous system (SNS) and the renin-angiotensin-aldosterone system (RAAS) are affected and that are also associated with the regulation of salt-water balance and cardiovascular function.14

Hypertension a condition that can be controlled. It has been claimed that targeted reductions in the number of persons with hypertension are projected to result in significant decreases in the burden of cardiovascular disease. The acceptance of healthy lifestyle by every individual is essential for the prohibition of high BP, according to the JNC-7. Therefore, accurate estimates of hypertension are required to develop effective control strategies.15

A two-dimensional methodology is utilized for the underlying treatment of hypertension, with an emphasis on way of life changes and extra pharmacological administration. Lifestyle management, also known as non-pharmacological treatment, is essential for both individual with hypertension and individual without hypertension. Non-hypertensive individual, including those with pre-hypertension, can reduce their risk of BP-related clinical consequences and lower their blood pressure through lifestyle modifications. If the patient is able to maintain lifestyle changes, these interventions may enable drug step-down in hypertensive patients whose blood pressure is controlled by medication. The therapy is successful when a various aspects of the subject’s life are considered because essential hypertension is thought to be the result of interactions between genes and the environment. In the treatment of high blood pressure, it is crucial to control environmental factors considering they are powerful and cause the majority of variations in BP across individuals and communities. Consumption of inactivity, psychosocial stress, alcohol, and a diet deficient in fibre and potassium are all important lifestyle or environmental factors. Obesity, particularly truncal obesity, is a strong proximate determinant of high blood pressure in Indians as well. It is well known that lifestyle factors contribute to their onset.16

All individuals with hypertension should start non-pharmacologic therapies. Changing one’s lifestyle early on can lessen the likelihood of developing other diseases and even eliminate the need for pharmaceutical treatment. However, maintaining a healthy lifestyle is insufficient or However, majority of subjects will require pharmaceutical therapies to manage their blood pressure, and leading a healthy lifestyle is inadequate or difficult to adhere to.17

The following drugs are used to treat high blood pressure18:

Diuretics (Water pills): The elimination of salt and water from the body is aided by these medications. These are frequently the 1st medications used to treat high BP. Depending on the measurements of blood pressure and other medical conditions, such as kidney disease or heart failure, diuretics can be grouped into a number of different categories, such as potassium sparing, loop, and thiazide.

Angiotensin-converting enzyme (ACE) inhibitors: By causing the secretion of a natural chemicals that narrows the blood vessels, ACE inhibitors assist in blood vessel relaxation. Benazepril (Lotensin), lisinopril (Prinivil, Zestril), captopril, and others are examples of angiotensin-converting enzyme inhibitors.

Angiotensin II receptor blockers (ARBs): Additionally, angiotensin II receptor antagonists relax blood vessels. They prevent the natural chemical that dilates blood vessels from acting, not from developing. Losartan (Cozaar), candesartan (Atacand), and other Angiotensin II receptor blockers include.

Alpha blockers, Alpha-beta blockers, Beta Blockers, Aldosterone antagonists, Renin inhibitor, Vasodilators, and Central acting agents are other medications that can be used to treat high blood pressure.

Ayurvedic medications have also been shown to help with conditions like hypertension and improve heart function for a long time. To ensure that the patient’s health is a primary concern, various principles and guidelines are described in Ayurvedic texts. Jatamamsi, Sarpagandha, Rason, and Arjuna are some of the therapeutic plants used to treat hypertension.19

Shamak Yoga is the type of yoga which also helps to treat hypertension. “Shamak Yoga” is a polyherbal combination of 10 Ayurvedic plants. In individuals with moderate hypertension, Shamak Yoga was shown to be statistically significant and equivalent to Atenolol for systolic and diastolic blood pressure.20

This observational study will highlight the prevalence of risk factors of hypertension among population of Wardha district between age group of 35-60 years.

Based on The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) standard which was published 2003 and the American College of Cardiology/American Heart Association (ACC/AHA) guideline, Hypertension prevalence based on sex and age was 22.3% (95% CI: 20.6, 24.1) and 36.5% (31.1, 41.8), respectively.7

This study is limited to Hypertensive population of Wardha district between age group 35-60 years.

Compared to males, older women had a greater risk of developing hypertension (AOR, 4.24; 95% CI, 3.94-4.57 for men aged 50–54 and AOR, 5.58; 95% CI, 5.16–6.03 for women aged 40–49). Other than age, it has been shown that drinking alcohol, having diabetes, and not working are the main risk factors for this condition in women. In order to prevent the early onset of hypertension, teenagers and adults in India should be encouraged to adopt new lifestyle habits including eating a diet high in fruits and vegetables and getting regular blood pressure checks.21

19.1% of people worldwide had hypertension. Adults were 3.6 times more likely to develop hypertension if they had known diabetes mellitus. Risk factors for hypertension include a family history of HT (OR:1.82), cigarette use (OR:1.94), and alcohol use (OR:1.54 for men). With a BMI of 25 to 29.9 and below 30 correspondingly, it was shown that the risk of hypertension increased to 1.45 times and 2.27 times, respectively. Age, family history of hypertension, known history of diabetes mellitus, and body mass index were the factors of hypertension in multiple logistic regression analysis.22

As similar study is not conducted in Wardha district the result from this study will add data to the data base related to prevalence of risk factors of hypertension.

Ethical approval

Approval by the Institutional Ethics Committee Ref. No. DMIHER (DU)/IEC/2023/594.

Datta Meghe Institute of Higher Education and Research Sawangi (M) Wardha- 442107 Maharashtra, India.

Data availability

Underlying data

No underlying data are associated with this article.

Extended data

Zenodo: Check list Hypertension, https://zenodo.org/record/7997228 (Amruta Dadmal, 2023).

This project contains the following extended data:

Check list hypertension.doc

Data are available under the terms of the Creative Commons Attribution 4.0 International (CC-BY 4.0)

References

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  • 4.  Kota V, Kumar S, Wanjari A, et al.: Lifestyle modification and nutrition in preventing prehypertension and hypertension — Narrative review. International Journal of Nutrition, Pharmacology, Neurological Diseases. 2023 Mar; 13(1): 9.
  • 5.  Gupta R: Hypertension in India— definition, prevalence and evaluation. J. Indian Med. Assoc. 01 Mar 1999; 97(3): 74–80. PubMed Abstract
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  • 8.   Primary Hypertension (Formerly Known as Essential Hypertension) .Reference Source
  • 9.   Secondary hypertension. Reference Source
  • 10.  Dhingra G, Jungari ML, Shrivastava D: Study of Management of Pregnancy Induced Hypertension by Magnesium Sulfate and a Calcium Channel Blocker in Central India. IJCRR. 2020; 12(15): 140–144. Publisher Full Text
  • 11.  Anchala R, Kannuri NK, Pant H, et al.: Hypertension in India: a systematic review and meta-analysis of prevalence, awareness, and control of hypertension. J. Hypertens. 2014 Apr 30; 32: 1170–1177. PubMed Abstract | Publisher Full Text | Free Full Text
  • 12.  SPSS Statistics Version 22: A Practical Guide - Murdoch University.cited 2023 Jun. Reference Source
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Dadmal A and Mude G. Estimation of prevalence of risk factor of hypertension among population of Wardha district between age group of 35-60 years: a study protocol. [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1016 (https://doi.org/10.12688/f1000research.135188.1)
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Reviewer Report 03 Oct 2023
Jelina Basnet, Department of Cell and Molecular Biology, University of Mississippi Medical Center, Jackson, MS, USA 
Approved with Reservations
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https://doi.org/10.5256/f1000research.148292.r206364
The overall approach of study is convincing. The rationale and aim of the study can be strengthened by providing a more detailed overview of why you chose to do the study on the prevalence of hypertension risk factor in Wardha ... Continue reading
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Basnet J. Reviewer Report For: Estimation of prevalence of risk factor of hypertension among population of Wardha district between age group of 35-60 years: a study protocol. [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1016 (https://doi.org/10.5256/f1000research.148292.r206364)
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  • Author Response 06 Oct 2023
    Amruta Dadmal, Clinical Research, School of Allied Health Sciences, Datta Meghe Institute of Higher Education and Research, Wardha, India
    06 Oct 2023
    Author Response
    Thank you for your response, and for the valuable time that you have given for my article.
    As I am PG student of Clinical Research from Datta Meghe Institute of ... Continue reading
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  • Author Response 06 Oct 2023
    Amruta Dadmal, Clinical Research, School of Allied Health Sciences, Datta Meghe Institute of Higher Education and Research, Wardha, India
    06 Oct 2023
    Author Response
    Thank you for your response, and for the valuable time that you have given for my article.
    As I am PG student of Clinical Research from Datta Meghe Institute of ... Continue reading
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