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CTRI Number  CTRI/2024/06/068261 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study on Knowledge Attitude and Practice Towards Risk Factor and Early Detection of Noncommunicable Diseases in Rural Area of Udupi District  
Scientific Title of Study   Study on knowledge attitude and practice towards risk factor and early detection of Noncommunicable diseases in rural area of Udupi district 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varun suvarna  
Designation  Post-Graduate student Masters in Hospital Administration 
Affiliation  Prasanna school of public health MAHE Manipal 
Address  Department of social and health innovation PSPH MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  8310878554  
Fax    
Email  varunsuvarna09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swathi KS 
Designation  Associate professor  
Affiliation  Prasanna school of public health MAHE Manipal 
Address  Department of social and health innovation PSPH MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Swathi KS 
Designation  Associate professor  
Affiliation  Prasanna school of public health MAHE Manipal 
Address  Department of social and health innovation PSPH MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9481749911  
Fax    
Email  swathi.ks@manipal.edu  
 
Source of Monetary or Material Support  
Prasanna school pf public health, MAHE, Manipal Udupi Karnataka-576104 
 
Primary Sponsor  
Name  varun suvarna  
Address  Department of social and health inovation PSPH MAHE Manipal udupi, karnataka, INDIA -576104 
Type of Sponsor  Other [self] 
 
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 Swathi K S  Prasanna school of public health, MAHE Manipal   Prasanna school of public health,Department of social and health inovation ,MAHE Manipal -576104, karnataka India
Udupi
KARNATAKA 
9481749911

swathi.ks@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college and kasturba hospital insttitutional ethics committee( student research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  volunteer participation 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals residing in rural areas of district
individuals available and willing to participate in the study 
 
ExclusionCriteria 
Details  Individuals residing in urban areas of district
Children and adolescents below the 18 years  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of this study has the potential to improve public health and to determimne the efects of intervention  8-9 months 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable   not applicable 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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)   15/06/2024 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Protocol (Description of the Project)

 Title of the project:

‘‘Study on knowledge, attitude and practice on risk factor and early detection of Non-communicable diseases in rural area of Udupi district”

 Type of Study:

Cross sectional study

 Aims & objectives:

 Aim: To study the knowledge, attitude and practices related to risk factor and early detection of non-communicable diseases among the rural area in Udupi district.

Objective:

       To evaluate the current level of knowledge among the rural area of Udupi district regarding common risk of non-communicable diseases.

       To assess the attitude of the rural population towards risk factor and early detection of non-communicable diseases.

       To examine the current practices related to early detection of non-communicable disease.

Justification for study (whether of national significance with rationale) :

Non-communicable diseases like heart diseases, diabetes and cancer are increasingly prevalent, not only in urban but also in rural areas. Rural population often face health disparities including limited access to healthcare and health education. This study address these disparities and promote health equity. Many non-communicable diseases are preventable or manageable with early detection and lifestyle changes. Assessing knowledge and practice is essential for prevention. Early detection of non-communicable diseases can significantly improve outcome and reduce the economic burden on patients and healthcare system. Understanding the specific needs of the rural population allow for more efficient allocation of healthcare resource and funding. Addressing non-communicable diseases in rural area can have broader social and economic impacts. It can improve the quality of life, workforce productivity and overall community well-being.

 Study period:

From October 2023 to April 2024

 Sample size :

Calculating sample size for an infinite population involves using a formula that considers a desired level of confidence, a margin of error, and an estimated population proportion. The formula for calculating sample size for an infinite population is:

15n=1.962×0.51-0.50.052=384.16"> 15n=1.962×0.51-0.50.052=384.16">

   Where:

  • n is the required sample size.
  • z is the Z-score corresponding to the desired level of confidence. For a 95% confidence level, the Z-score is approximately 1.96.
  • pÌ‚ is the population proportion.
  • ε is the desired margin of error, representing the maximum acceptable difference between the sample statistic and the population parameter.

 

15n=1.962×0.51-0.50.052=384.16">

So, in this case, you would need a sample size of approximately 384.

  Materials and methods:   

a) Inclusion and exclusion criteria:

Inclusion criteria:

          Individuals residing in rural areas of district

          Adults aged 18 years and above

          Individuals available and willing to participate in the study

Exclusion criteria:

          Individuals residing in urban areas of district

          Children and adolescents below the 18 years

          Individuals who refuse to  participant

         Individuals who are temporary residents in rural area and not part of the local population 

b) Biological materials required (type - blood, tissue etc and quantity): Nil

           

c) Statistical methods:

Descriptive statistics and advanced statistical tests like correlations, regression, and T-tests for independent samples will be performed.

 

d) Tools used:

Structured questionnaire for collecting data and Jamovi statistical software for analyzing data.

 Detailed description of procedure / processes:  

The study encompasses obtaining necessary ethical approval and permission for data collection through a validated questionnaire. The study design is a cross-sectional analysis conducted in the rural community of India, specifically in Udupi district in Karnataka. Participants eligible for the study are adult 18 years or older, who are the heads of their respective rural households in Udupi district and can communicate in English or Kannada.

The study are defined as households in the study area with a residency duration of at least 1 year and respondents encompass adult individuals, both male and female, who meets the inclusion criteria. These eligible participants receive a self-administered questionnaire available in English and Kannada. The questionnaire will focus on collecting information related to socio-demographics, perception towards tobacco use, health literacy level, relying on traditional methods and Limited preventive measures

Data are obtained in the three panchayat area those are 80th Bdagabettu, Alevoor and Kukehali.

A 5-point Likert scale will be used to measure the responses and the data analysis will be done by conducting regression and t-tests for independent samples.

 Outcome measures:

The outcome of this study has the potential to improve public health, reduce the impact of non-communicable diseases and empower rural communities to make informed decisions about their health. It can also guide policies and interventions that address the specific needs of the population in Udupi district.

 Potential risks and benefits :

Risk: Risk in this observational study is minimal, the study itself could have introduced some risk such as privacy violation, breach of confidentiality and the potential for participant distress if the questions asked were sensitive or personal.

Benefits:Understanding the level of knowledge, attitude and practice related to NCDs in rural areas can inform public health initiatives. It can help design targeted interventions to raise the awareness, promote healthier practice.The data from this study can be used to tailor healthcare and awareness programs to the specific need of the rural population in Udupi district.Effective prevention and early detection can help reduce the financial burden of NCDs on the individual and healthcare system.

 Review of literature (within 1000 words):  

The review studied on the risk factor and early detection of non-communicable diseases in rural areas. Researcher used the databases such as google scholar, scopes and web of science to identify the study using the keywords non-communicable diseases, risk factors and knowledge of NCDs. The studies published in English literature are considered. The relevant article are considered between 2016 to2023. Around 10 to 12 studies are considered for the review. Many of the studies are done in different district of India, southern Uganda. The researcher used the quantitative cross- sectional study, questionnaire are used to collect the data. Some study used the in-depth interviews for collection of the study. Then data are analyzed using the statistical method like spss, logistic regression and correlation analysis.

 

Non-communicable diseases are the major global causes of death, accounting for more fatalities than all other causes combined, and they disproportionately affect the world’s low and middle-income populations (1). Urbanization and associated life style change may increase the non-communicable diseases (2). The rapid expansion of the economy and ensuring progress have led to a transition from the prevalence of infection diseases to an increasing prevalence of non-communicable diseases (9). The socioeconomic consequences of non-communicable diseases are also impacting advancement towards achieving the millennium development goals, which has significant implication for both poverty reduction and economic growth (7). Over the past twenty year there has been a steady and concerning deterioration in the healthcare system of the nation (4).

 

Key risk factor associated with non-communicable diseases includes elevated blood pressure, high level of cholesterol in the blood stream, excess body weight and the use of tobacco (3). Long-term consumption of smokeless tobacco has been shown to elevate the risk of fatal heart attack and stroke (10). Smoking also increases the risk of developing these diseases, primarily through distinct mechanisms (3). It’s important to educate the population about the consequences of both smoking and the use of smokeless tobacco (10).

Estimate of the diseases burden derived from analysing routine health data are valuable for making informed decisions about resource allocation and strategic investments in the prevention and management of non-communicable disease (8).  In 2016, the government of India restructured the non-communicable disease control program in line with its dedication to reducing early mortality caused by non-communicable diseases (5). To effectively plan and address non-communicable diseases, it is crucial to have precise assessments of their prevalence and factor that contribute to their risk (8). The challenges in early detection and treatment of non-communicable diseases in rural India encompass limited awareness, financial constraints, limited healthcare accessibility and shortage of medical professionals (6). These obstacles are mitigated to some extend through the delegation of responsibilities to community health workers (6). Community health worker are widely acknowledged for providing various preventive healthcare services directly to beneficiaries particularly in low and middle income countries (5).

REFERENCES:    

  1. Ade, A., Chethana, K. V., Mane, A., & Hiremath, S. G. (2014). Non-communicable diseases: Awareness of risk factors and lifestyle among rural adolescents. Int J Biol Med Res5(1), 3769-3771.
  2. Kavishe, B., Biraro, S., Baisley, K., Vanobberghen, F., Kapiga, S., Munderi, P., ... & Grosskurth, H. (2015). High prevalence of hypertension and of risk factors for non-communicable diseases (NCDs): a population based cross-sectional survey of NCDS and HIV infection in Northwestern Tanzania and Southern Uganda. BMC medicine13(1), 1-21.
  3. Saxena, V., Kandpal, S. D., Goel, D., & Bansal, S. (2011). Prevalence of Risk-Factors of Non-Communicable Diseases in Rural Population of Block Doiwala Dehradun. Indian Journal of Community Health23(2), 65-68.
  4. Nongkynrih, B., Patro, B. K., & Pandav, C. S. (2004). Current status of communicable and non-communicable diseases in India. Japi52, 118-23.
  5. Basu, P., Mahajan, M., Patira, N., Prasad, S., Mogri, S., Muwonge, R., ... & Jain, K. (2019). A pilot study to evaluate home-based screening for the common non-communicable diseases by a dedicated cadre of community health workers in a rural setting in India. BMC Public Health19(1), 1-12.
  6. Zaman, S. B., De Silva, N., Goh, T. Y., Evans, R. G., Singh, R., Singh, R., ... & Thrift, A. G. (2023). Design and development of a clinical decision support system for community health workers to support early detection and management of non-communicable disease. BMJ Innovations9(1).
  7. Islam, S. M. S., Purnat, T. D., Phuong, N. T. A., Mwingira, U., Schacht, K., & Fröschl, G. (2014). Non‐Communicable Diseases (NCDs) in developing countries: a symposium report. Globalization and health, 10(1), 1-8.
  8. Sarma, P. S., Sadanandan, R., Thulaseedharan, J. V., Soman, B., Srinivasan, K., Varma, R. P., ... & Kutty, R. V. (2019). Prevalence of risk factors of non-communicable diseases in Kerala, India: results of a cross-sectional study. BMJ open9(11), e027880.
  9. Ross, S., Chadha, K., Mishra, S., Lewington, S., Shepperd, S., Gathani, T., & NCDRI study collaborators Albert Sandra Bhatnagar Apoorva Chadha Kashika Gathani Toral Lacey Ben Lewington Sarah Mishra Shantanu Roest Jennifer Ross Stephanie Shepperd Sasha Violata Mara Gupta Sanjay Singh Vivek Sarkar Rajiv. (2022). The burden of risk factors for non-communicable disease in rural Bihar, India: a comparative study with national health surveys. BMC public health22(1), 1538.
  10. Mahajan, M., Naik, N., Jain, K., Patira, N., Prasad, S., Mogri, S., ... & Basu, P. (2019). Study of knowledge, attitudes, and practices toward risk factors and early detection of noncommunicable diseases among rural women in India. Journal of Global Oncology5, 1-10.

 
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