| CTRI Number |
CTRI/2021/02/031008 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
21/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An intervention study to evaluate the effectiveness of Oral health education to ASHA workers at primary health centers. |
|
Scientific Title of Study
|
Strengthening of Primary oral health care knowledge by oral health education among Accredited Social Health Activists at the rural Primary Health Centers in Dharwad Taluk, Karnataka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini Marathe |
| Designation |
1st year PG student |
| Affiliation |
S.D.M.Dental college and hospital. |
| Address |
Department of Public Health Dentistry,S.D.M.Dental college and hospital, Sattur, Dharwad.
Department of Public Health Dentistry,S.D.M.Dental college and hospital, Sattur, Dharwad.
Dharwad
KARNATAKA
580004
India |
| Phone |
9900083849 |
| Fax |
|
| Email |
amishrikoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini Marathe |
| Designation |
1st year PG student |
| Affiliation |
S.D.M.Dental college and hospital. |
| Address |
Department of Public Health Dentistry,S.D.M.Dental college and hospital, Sattur, Dharwad.
Department of Public Health Dentistry,S.D.M.Dental college and hospital, Sattur, Dharwad.
Dharwad
KARNATAKA
580004
India |
| Phone |
9900083849 |
| Fax |
|
| Email |
amishrikoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwini Marathe |
| Designation |
1st year PG student |
| Affiliation |
S.D.M.Dental college and hospital. |
| Address |
Department of Public Health Dentistry,S.D.M.Dental college and hospital, Sattur, Dharwad.
Department of Public Health Dentistry,S.D.M.Dental college and hospital, Sattur, Dharwad.
Dharwad
KARNATAKA
580004
India |
| Phone |
9900083849 |
| Fax |
|
| Email |
amishrikoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural primary health centers at Dharwad Taluk.
1 Alnavar PHC
2 Aminbhavi PHC
3 Garag PHC
4 Kotu PHC
5 Mugad PHC
6 U.Betegeri PHC
|
|
|
Primary Sponsor
|
| Name |
Ashwini Marathe |
| Address |
1st floor, Amrut building, 4th main 8th cross, Gandhinagar, Dharwad. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shodan M |
Assoc Proffessor, Dept of Public health Dentistry.SDM College of Dental Sciences and Hospital.Sattur, Dharwad, Karnataka. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shodan M |
SDM College of Dental sciences and Hospital |
Department of Public health dentistry, Room No 10
Dharwad
KARNATAKA |
9886811031
shodanm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDSH-IEC, IRB.No. 2018/P/COMM/58 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral health care knowledge of ASHA workers. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Basic Oral Health Education |
Basic Oral health Education to control group. |
| Intervention |
Oral health education based on training manual. |
Oral health education based on "Training manual on oral health promotion for Health workers" for experimental group. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Accrediated social health activists at rural primary health centres Dharwad. |
|
| ExclusionCriteria |
| Details |
Accrediated social health activists not willing to participate, not present or on leave while providing Oral health education. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Oral health care knowledge among Acrediated social health activists. |
Oral health education after 4weeks of baseline data collection. Increase in oral health care knowledge analyzed by same questionnaire after 4 weeks of Oral health education |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in oral health care knowledge among rural population under ASHA workers trained using the manual |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/02/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomizes,double blinded and parallel group study to evaluate the effectiveness of Oral heath education based on "Training manual on promotion of Oral health care for Health Workers" introduced by NOHP Ministry of Family and Health Welfare, Goverment of India to Accrediated Social Health Activists ( ASHA Workers ). To strengthen the primary oral health care knowledge among ASHA workers at rural primary health centers in Dharwad Taluk. |