| CTRI Number |
CTRI/2021/12/038412 [Registered on: 03/12/2021] Trial Registered Prospectively |
| Last Modified On: |
02/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative exploratory study based on expert in-depth interviews. |
| Study Design |
Other |
|
Public Title of Study
|
An in-depth interview-based study to understand the implementation of oral health-related policies and strategies in India. |
|
Scientific Title of Study
|
An appraisal of the oral healthcare and oral health policy implementation in India – A Qualitative Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Balraj |
| Designation |
PhD candidate |
| Affiliation |
Prasanna School of Public Health, MAHE. |
| Address |
Room No. 36, Prasanna school of Public Health, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9742504911 |
| Fax |
|
| Email |
lakshmi.balraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Helmut Brand |
| Designation |
Founding director |
| Affiliation |
Prasanna School of Public Health, MAHE. |
| Address |
Directors office, Prasanna School of Public Health, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9606978548 |
| Fax |
|
| Email |
helmut.brand@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Balraj |
| Designation |
PhD student |
| Affiliation |
Prasanna School of Public Health, MAHE. |
| Address |
Room No. 36, Prasanna School of Public Health, MAHE, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9742504911 |
| Fax |
|
| Email |
lakshmi.balraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| The project is self-funded by the PI. Infrastructural support by Prasanna School of Public Health, MAHE, Manipal. |
|
|
Primary Sponsor
|
| Name |
Lakshmi Balraj |
| Address |
Prasanna school of public health, MAHE, Manipal, Karnataka - 576104. |
| 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 |
| Dr Lakshmi Balraj |
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
IEC Secretariat, Room no. 22, Ground floor, Faculty room complex, KMC, Manipal. Ph.: 08202933522. E: iec.kmc@manipal.edu
Udupi
KARNATAKA |
9742504911
lakshmi.balraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA. Key policy experts and senior leaders in the field of oral health and/or policy planning/implementation included for key-informants interview. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Key informants. Owing to the ‘high-level’ nature of this study and the importance of participants having an extensive understanding and/or experience in oral health policy and planning, only senior leaders and key experts in India will be approached for participation. A combination of purposive and snowball sampling schemes will be used to select the key informants. The following main streams of participants will be targeted: (i) the academic professoriate, (ii) policymakers, (iii) bureaucrats or civil servants implementing the oral health-related policies and strategies at state/regional level.
Age/gender limits: NA |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study outcome will be the perspectives of key informants which will help in better
understanding the context of oral health policy implementation. Their perspectives and
recommendations will serve as advocacy calls to action to legislators and policymakers towards implementation of sustainable oral health strategic plans for India. So, the outcomes of this study
will be discussed as related to the qualitative data and will not be looking for any associations in the data. |
A prior consent will be obtained before conducting and audio-recording the interviews. Field notes will be taken during and immediately after the interviews. The recorded interviews will be transcribed verbatim before analysis is done by Atlas-ti software. Participant identities will be deidentified during analysis and reporting. The transcripts and the audio recordings of the interview will be immediately deleted after the findings are published. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Qualitative data on oral health strategies and/or policies implemented at a state or regional level in India. Factors influencing their implementation. |
Key informants (in this case state nodal officers) will be identified through snowballing after interviewing the initial few identified key experts/ senior leaders in the field. As and when state nodal (dental) officers will be interviewed, the transcripts will be coded to analyze and obtain the secondary outcome. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
23/12/2021 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None till now. Will publish findings of the study once completed and submit the details of the same. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is conducted to better understand the national efforts
focused on improving the oral healthcare scenario in India. Literature suggests that the national oral health
policy of India (OHP) was drafted way back in 1986. In 1994, the national oral health policy developed by DCI
was accepted as a part of National Health Policy of India. The current status of the policy remains bleak even
today. Although there is an increasing focus towards oral health policy among the researchers, much of the
available literature is limited to recommendations and suggestions for a sustainable OHP in India. Recently, as a
part of National Health Policy 2017, the working draft of national oral health policy by MoHFW was released on public domain seeking for public comments. Our research aims to fill the research gaps in oral health
policy research. Hence, an in depth understanding of various aspects of the OHP-implementation
process including an exploration of the factors influencing the implementation OHP in India will form the crux of our research.
Right from its inception, oral health policy has been incorporated to be a part of National health
policy (NHP) of India. Another recent component of NHP 2017 which envisages to channelize
some dedicated efforts towards oral health is the recently launched national healthcare scheme
‘Ayushman Bharat’. This scheme promises to provide certain basic oral health services to the
entitled beneficiaries under the PM-JAY insurance scheme. It also aims to
incorporate oral healthcare into the primary healthcare level by means of Health and Wellness
Centers (HWCs). Not much is known and scientifically published about what this scheme potentially holds for the oral health advancement in India. Hence, the research also attempts to
understand the perspectives of the key informants regarding the potential of the recently
launched ‘Ayushman Bharat’ and its inclusivity of oral health. The broad aim of the study is to better understand the national efforts focused on improving
the oral healthcare scenario in India. The main objectives of the study are: • To understand the current status of national oral health policy implementation in India. • To understand the policy process and the factors influencing the implementation of oral health-related policies in India at national and state level. • To understand the scope and potential of the national health insurance scheme
‘Ayushman Bharat’ in relation to oral health in India. |