| CTRI Number |
CTRI/2024/01/061592 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how people in Udupi take care of their general and oral health |
|
Scientific Title of Study
|
Assessment of General and Oral health literacy levels among outpatients visiting Dental Outreach Programs and Camps in Udupi District, Karnataka State |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RITIKA VASANTH |
| Designation |
MHA second year student |
| Affiliation |
Prasanna School of Public Health |
| Address |
LH3, Department of Social and Health Innovation ,Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7994572376 |
| Fax |
|
| Email |
ritika.psphmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Rani |
| Designation |
Associate Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Dept. of Social and Health Innovation, Prasanna School of Public Health, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310214742 |
| Fax |
|
| Email |
usha.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramprasad V P |
| Designation |
Professor and Head , Dept of Public Health Dentistry, MCODS, Manipal |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Dept. of Public Health Dentistry , Room No. 08, Second floor, MCODS Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845100424 |
| Fax |
|
| Email |
vasthare.ram@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Social and Health Innovation ,Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
DR RITIKA VASANTH |
| Address |
Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka |
| 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 Ritika Vasanth |
Manipal College of Dental Sciences |
room no.2 ,Department of Public Health Dentistry, Manipla college of Dental Sciences, Eshwar Nagar, Manipal, Karnataka
Udupi
KARNATAKA |
7994572376
ritika.psphmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and kasturba Hospital Institutional Ethics Committee -2(student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged 18 years and above
2. Participants who come for various District Health Programs organized by Manipal College
of Dental Sciences
3. Participants who are willing to the study, who have signed the consent form. |
|
| ExclusionCriteria |
| Details |
1. Participants who are not physically or mentally stable
2. Participants who have severe language barriers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A questionnaire consisting of 13 questions related to basic HL and another
questionnaire which is divided into three parts to assess the Oral health literacy level will be given to
the participant, and the outcome will be derived based on the data collected from the questionnaire. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Title of the project: Assessment of General and Oral Health Literacy Levels among outpatients visiting Dental Outreach Programs and Camps in Udupi District, Karnataka State. 2. Type of Study: Prospective study- cross sectional study 3. Aims & objectives (hypotheses if applicable): Aim: To assess the general and oral health literacy levels and to identify the potential factors contributing to the health literacy levels among the outpatients visiting Dental Outreach Programs and Camps in Udupi District. Objectives of the study: • To assess the general health literacy levels among outpatients visiting Dental Outreach Programs and Camps in Udupi District through a validated assessment tool • To explore the oral health literacy levels among outpatients visiting Dental Outreach Programs and Camps in Udupi District through a validated assessment tool • To identify the potential factors contributing to the health literacy levels. 4. Justification for study (whether of national significance with rationale): Health literacy plays an important role in an individual’s ability to understand, navigate, and make informed decisions about their health. By understanding the health literacy level of the community in Udupi District, we can gain insights into their comprehension of health-related information and services, including oral health practices. This study can help fill the research gaps and contribute to the understanding of health literacy in a population. Over the past two decades, there’s been a growing emphasis on a concept benefiting personal and public health and the healthcare system’s stability. This focus is crucial amid the rise of non-communicable diseases (NCDs) and their costs. It highlights the need for people to engage more in managing their health efficiently. Limited health literacy connects to struggles in grasping health information, lack of disease understanding, and medication nonadherence. This results in poor health, high mortality rates, and health disparities. Oral health literacy is very important in maintaining good oral hygiene practices and preventing oral diseases. Identifying potential gaps in oral health literacy among adults can guide the implementation of targeted oral health promotion initiatives and health address oral health inequalities within the community. Our study aims to shed light on the influence of health literacy levels on patient’s interactions within the healthcare system and their participation in making treatment choices. This research study can inform healthcare providers and policymakers about the most effective ways to communicate health information to the target population. This in turn can lead to enhanced patient-provider communication, increased adherence to treatment plans, and better overall health outcomes. Our study aims to shed light on the influence of health literacy levels on patient’s interactions within the healthcare system and their participation in making treatment choices. This research study can inform healthcare providers and policymakers about the most effective ways to communicate health information to the target population. This in turn can lead to enhanced patient-provider communication, increased adherence to treatment plans, and better overall health outcomes. 5. Departments involved: Department of Social and Health Innovation, Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education (MAHE), Manipal Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal 6. Study period: A time of 6 months from October 2023 to March 2024 will be utilized to complete this study. 7. Sample size: Complete Time-bound enumeration. 8. Materials and methods: • Inclusion criteria: 1. Participants aged 18 years and above 2. Participants who come for various District Health Programs organized by Manipal College of Dental Sciences 3. Participants who are willing to the study, who have signed the consent form. • Exclusion Criteria: 1. Participants who are not physically or mentally stable 2. Participants who have severe language barriers b) Biological materials required (type - blood, tissue etc., and quantity): Yes ☠No �’ i) Biological material: Nil. ii) Biosafety Measures: Mention the biosafety concerns and precautions taken: (e.g.: Specific training involved, transportation, testing precautions, lab credentials, and disposal method) c) Statistical methods: Descriptive statistics like Mean and standard deviation will be used for continuous variables. For categorical variables, frequency and proportion will be used. Graphical and pictorial tools like pie charts and bar graphs will be used to project participants’ health literacy levels. Inferential Statistical tools like the Chi-square test will be used in the analysis. d) Tools used: The predesigned EMAHL13 HL questionnaire will be used for general health literacy and the OHLI questionnaire will be used for Oral health literacy. We have email permission from the author to reuse the same questionnaire and use it by translating it into Indian local languages. 9. Detailed description of procedure / processes: Plan for gathering data from participants using a predesigned questionnaire after obtaining approval from the ethics committee. For translation of the questionnaire The “forward-backward-forward†method will be used. The questionnaire will be translated from English to Kannada and Kannada to English and then it will be back translated to Kannada by a bilingual expert. The Kannada version will be validated by the experts. The validated version of the English and Kannada questionnaire will be used for the study. Study participants will give their consent in writing. They will be requested to fill out a self-administered tool and provided with clarification on the questionnaire if needed. Collected data will undergo analysis, evaluation, and organization in an Excel sheet. To maintain confidentiality, each participant will be assigned a distinct code. 10. Outcome measures: A questionnaire consisting of 13 questions related to basic HL and another questionnaire which is divided into three parts to assess the Oral health literacy level will be given to the participant, and the outcome will be derived based on the data collected from the questionnaire. 11. Potential risks and benefits: The participants are at a minor increase over minimal risk because this study is questionnaire-based. The benefit of this study is that it enables the participants to assess their degree of health literacy regarding general and oral health. 12. Ethical considerations and methods to address issues: The study protocol will be submitted to the Institutional Ethics Committee (IEC). The study participant’s confidentiality will be rigorously respected. 13. Budget (give details) and proposed funding source: The study is self-funded |