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
|
|
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
|
|
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 |