| CTRI Number |
CTRI/2017/01/007700 [Registered on: 13/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Motivational interviewing for ASHA and Anganwadi workers to bring about behavior change related to oral health at Kaiwara |
|
Scientific Title of Study
|
Effectiveness of Motivational Interviewing to facilitate behaviour change among health workers at Kaiwara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Shenoy K |
| Designation |
Post Graduate student |
| Affiliation |
Faculty of Dental Sciences , MSRUAS |
| Address |
Department of Public Health Dentistry
Faculty of Dental Sciences
M.S. Ramaiah University of Applied Sciences
MSRIT Post
MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9844994993 |
| Fax |
|
| Email |
sne.shen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anitha Sagarkar |
| Designation |
Reader |
| Affiliation |
Faculty of Dental Sciences , MSRUAS |
| Address |
Department of Public Health Dentistry
Faculty of Dental Sciences
M.S. Ramaiah University of Applied Sciences
MSRIT Post
MSR Nagar
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9448520027 |
| Fax |
|
| Email |
draniraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anitha Sagarkar |
| Designation |
Reader |
| Affiliation |
Faculty of Dental Sciences , MSRUAS |
| Address |
Department of Public Health Dentistry
Faculty of Dental Sciences
M.S. Ramaiah University of Applied Sciences
MSRIT Post
MSR Nagar
Bangalore
Koppal
KARNATAKA
560054
India |
| Phone |
9448520027 |
| Fax |
|
| Email |
draniraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, MSRUAS |
|
|
Primary Sponsor
|
| Name |
Faculty of Dental Sciences |
| Address |
Faculty of Dental Sciences , M.S.RAMAIAH UNIVERSITY OF APPLIED SCIENCES
MSRIT Post
MSR Nagar
Bangalore 560054 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sneha Shenoy K |
Primary Health Centre, Kaiwara |
Primary Health Centre, Kaiwara
Bangalore
KARNATAKA |
9844994993
sne.shen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.S.Ramaiah Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASHA and Anganwadi workers of PHC in Kaiwara |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Health education |
In this group baseline data will be assessed if the ASHA and Angawadi(health workers) are incorporating oral health in their general health promoting activity using questionnanire.Health education will be given and assessed using the same questionnaire to assess change in behaviour |
| Intervention |
Motivational Interviewing |
In this group baseline data will be assessed if the ASHA and Angawadi(health workers) are incorporating oral health in their general health promting activity using questionnanire.Motivational Interviewing will be done and assessed using the same questionnaire to assess change in behaviour |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All the ASHA and Anganwadi workers who work in PHC of Kaiwara |
|
| ExclusionCriteria |
| Details |
THe ASHA and Anganwadi workers who were absent on day of intervention |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess if oral health component is included in their general health promoting activities |
To assess if oral health component is included in their general health promoting activities |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if oral health component is included in their general health promoting activities post Motivational Interviewing and health education |
1st,2nd and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM: To assess the effectiveness of
motivational interviewing to facilitate behavioral change among health workers
at Kaiwara.
OBJECTIVES:
1.
To assess if oral health is incorporated in health promoting activities
of health workers and to identify the barriers for incorporation of oral health
component.
- To
motivate health workers to incorporate oral health component in their
health promoting activity through Motivational Interviewing.
- To
assess the incorporation of oral health component in health promoting
activities post intervention at the interval of 1, 2 and 3 months.
7.
MATERIALS AND METHODS.
7.1
SOURCE OF DATA
Administrative
limits of Primary Health Center (PHC) of Kaiwara, which is the rural field
practice area of the Department of Public Health Dentistry of M S Ramaiah
Dental College, Bangalore.
Study subjects: Health
workers of Primary Health Care centre of Kaiwara
.
Sample size :
All the ASHA and Anganwadi workers under Primary Health Care centre in Kaiwara.
STUDY
DESIGN: Interventional study
INCLUSION CRITERIA
Anganwadi and ASHA workers under
Primary Health Care centre in Kaiwara
7.2
METHOD OF COLLECTING DATA
The study has
been drafted into three phases as follows:
Informed consent: Written informed
consent will be taken from the subjects.
Socio
demographic details will be collected.
Phase I:
1) To assess if oral health component is
incorporated in health promoting activities among community health workers.
2) To identify the barriers for incorporating
oral health component .
Phase II:
1) To
motivate health workers to incorporate oral health component in their health
promoting activity through Motivational Interviewing approach.
Phase III:
1) Booster sessions will be
conducted at 3 intervals ie 1,2,3 months.
2) Questionnaire
will be given to assess incorporation of oral health component post
intervention at 3 intervals ie 1,2 and 3 months later. |