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CTRI Number  CTRI/2018/01/011377 [Registered on: 16/01/2018] Trial Registered Retrospectively
Last Modified On: 02/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Health education about oral cancer for rural community by Health workers  
Scientific Title of Study   Development of a Health Intervention Model(HIM) for Primary Health Care Work Force (PHCWF)in Implarting oral Cancer Information to Indian Rural Community 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shwetha KM 
Designation  Associate Professor 
Affiliation  Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences 
Address  Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences Gnanagangotri Campus New BEL road Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  08023600949  
Fax    
Email  shwethskm@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranganath 
Designation  Professor 
Affiliation  Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences 
Address  Dept of oral and maxilla facial surgery Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences Gnanagangotri Campus New BEL road Bengaluru

Bangalore
KARNATAKA
560054
India 
Phone  08023600949  
Fax    
Email  rang635@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shwetha KM 
Designation  Associate Professor 
Affiliation  Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences 
Address  Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences Gnanagangotri Campus New BEL road Bengaluru


KARNATAKA
560054
India 
Phone  08023600949  
Fax    
Email  shwethskm@yahoo.co.in  
 
Source of Monetary or Material Support  
Self Dept of Public Health DentistrY FDS, MSRUAS, New BEL road Bengaluru 560054 
 
Primary Sponsor  
Name  Self Shwetha KM 
Address  Faculty of Dental Sciences M.S.Ramaiah University of Applied Sciences New BEL road, Bengaluru 
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 
DrShwetha KM  Faculty of Dental Sciences, MS Ramaiah University of Health Sciences  Dept of Public Health Dentistry Room no 05 FDS, MSRUAS, new BEL road, Bengaluru-560054
Bangalore
KARNATAKA 
9845224049

shwethskm@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Working in rural areas 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Health education  Health education model for creating awareness about oral cancer among rural  
Comparator Agent  No health education   POster display at PHC 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Primary Health Care Workers at PHC, Sub-centre and ASHA 
 
ExclusionCriteria 
Details  primary Health Care Workers on contract basis 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in the intention to educate community.
2. Practicing Health education about oral cancer to the community 
3months  
 
Secondary Outcome  
Outcome  TimePoints 
Awareness about oral cancer in the rural community  6 months 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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   Phase 1 
Date of First Enrollment (India)   23/10/2017 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   no publications yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Oral cancer is the sixth most common cancer in the world and highly prevalent in in South-east Asian countries (Ken Russell Coelho2012, Warnakulasuriya S, 2010, Sully C  et al 2008). India has the highest prevalence of oral cancer in the world (20/100,000 population) and Incidence expected to rise by 2030 (Gupta B et al 2013, Ken Russell Coelho 2012, WHO 2005). There are challenges to tackle rise in the burden as there is inequality in the distribution of dental work force which is concentrated in urban areas. Primary health care facilities are established and successfully operating in our country since 1946 (park k 2011).  Various national health programs are reached to 1.3 billion Indian populations. The feasibility of utilising the primary health care personnel (PHCP) for promoting oral health is still in dawn stage.

So the possibility of leveraging on health care personnel to tackle the existing health burden, oral health promotion, and its need in  minimising challenges have to be established. Health education is a most important and powerful tool to address the issue as it is reported often in the literature.  The health education regarding the oral cancer and risk factors will be planned to the primary health care workforce. Health education based on theories or models help us to understand the factors that are influencing on behaviours. If the factors are properly understood the strategies and methods can be prepared which communicates better with the community and the goals are achieved. Theories are ‘‘useful in planning, implementing, and evaluating interventions’’ and are particularly valued in health promotion because they can explain influences on health as well as suggest ways where audience change can be achieved (Hall & Johnson-Turbes 2015; Jönsson et al. 2012, pine 2007).So this thesis will explore the feasible and sustainable health education model to create the awareness in the community regarding the oral cancer and its prevention

 
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